Job Title: Head – Quality Assurance & Regulatory Affairs (Medical Devices) Location: Visakhapatnam /Chennai Position Type: Full-Time Experience Level: Senior (Individual Contributor + Leadership Oversight) Reports To: CEO / COO / Head of Operations About the Role We are looking for a highly experienced and execution-driven QA/RA professional to lead our Quality and Regulatory function as we scale medical device manufacturing under FDA and EU MDR frameworks. This role is ideal for someone who combines deep regulatory expertise with a hands-on approach —someone who leads by doing, not just directing. You will be responsible for establishing and maintaining the entire Quality Management System (QMS) , ensuring regulatory compliance, and guiding the company through audits, certifications, and product registrations—while also being actively involved on the ground with documentation, process qualification, and compliance monitoring. Key Responsibilities Own and lead all aspects of Quality Assurance and Regulatory Affairs for medical device manufacturing and compliance Establish, implement, and maintain a fully compliant QMS aligned with ISO 13485 , FDA 21 CFR Part 820 , and EU MDR requirements Prepare and manage technical documentation , regulatory submissions , design dossiers , risk files , and CE/FDA pathways Act as the Management Representative for audits, inspections, and regulatory communications Lead internal audits , CAPAs , nonconformance investigations , and supplier qualification processes Oversee validation and qualification protocols (equipment, process, software) and ensure traceability and documentation control Guide the team through design transfer and ensure manufacturing readiness Develop and enforce quality culture across functions and teams Provide strategic regulatory guidance while staying actively involved in the execution of QA/RA tasks Qualifications Bachelor's or Master’s degree in Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field 7–12 years of experience in medical device QA/RA , with at least 3+ years in a leadership role Proven track record of working with FDA (QSR) , ISO 13485 , and EU MDR frameworks Experience in leading regulatory submissions for 510(k), CE Marking, and ISO audits Strong documentation, technical writing, and compliance skills Comfortable being hands-on: writing procedures, reviewing records, attending floor-level quality issues Excellent communication and leadership skills; able to interface with auditors, regulators, and internal teams Experience in a start-up or scale-up manufacturing environment is a strong plus What We’re Looking For A doer and leader who takes ownership and drives outcomes Someone who can build and lead systems , but also get into the details when required A compliance-focused mindset with the practicality to operate in a dynamic environment Someone passionate about building safe, effective, and regulatory-compliant medical technologies To Apply: Please send your resume and a short note on your most relevant QA/RA leadership experience to hr@adiuvodiagnostics.com Show more Show less
Company: Adiuvo Diagnostics Private Limited About Us: Adiuvo Diagnostics Private Limited, an ISO 13485:2016 QMS company, is a leader in developing innovative medical devices. We are seeking a Regulatory Head to oversee end-to-end regulatory affairs, ensuring compliance with US FDA, EU MDR, and Indian CDSCO requirements. Key Responsibilities: Seeking an experienced Mechanical Design Engineer with a background in new product development (NPD) for consumer electronics or medical devices. Key Responsibilities: Lead NPD Projects – Manage electro-mechanical and opto-mechanical design projects, ensuring adherence to budgets and timelines. CAD & Design Optimization – Proficient in Autodesk Fusion 360 and SolidWorks; optimize designs for manufacturability. Technical Documentation – Develop detailed specifications, GD&T, and manufacturing drawings. Simulation & Analysis – Use tools like Ansys for simulations, tolerance stack-up, and optical design analysis. Manufacturability – Apply DFM/DFA principles; experience with additive manufacturing and 3D printing. Material & Prototyping – Select materials and conduct prototyping/testing. Compliance Standards – Familiar with ISO 13485 and relevant medical device standards. Communication & Presentation – Strong technical communication and rendering skills. Qualifications: 2-4+ years in mechanical design engineering, NPD focus Strong understanding of mechanical principles and optical components
The Production Lead will oversee end-to-end manufacturing operations for active medical devices, ensuring smooth, efficient, and cost-effective production while maintaining compliance with ISO 13485:2016, FDA QSR (21 CFR Part 820), EU MDR, and GMP requirements. While regulatory submissions are handled separately, this role ensures production-level compliance, process validation, and continuous improvement in the shop floor environment. Key Responsibilities Production Management Plan and execute daily/weekly/monthly production schedules aligned with demand forecasts. Manage assembly, integration, and testing of active medical devices to meet quality and delivery commitments. Ensure cleanroom operations and adherence to production SOPs. Drive equipment qualification and process validation (IQ, OQ, PQ) at the production floor. Monitor and improve key production metrics: yield, first-pass success rate, downtime, scrap rate, and productivity . Ensure timely availability of materials, spares, and consumables by coordinating with supply chain. Support design transfer to production , ensuring prototypes scale effectively into full manufacturing. Production-Level Compliance & Quality Ensure production floor compliance with ISO 13485, GMP, and device master record (DMR)/device history record (DHR) requirements. Oversee in-process quality checks , functional testing, and batch release readiness. Implement CAPA, change control, and training programs for production teams. Collaborate with QA to ensure timely audit readiness , focusing on production-level practices. Maintain production documentation, validation records, and traceability. Team & Leadership Supervise production staff, technicians, and line engineers. Train and mentor the production team on good documentation practices (GDP), cleanroom behavior, and regulatory compliance . Drive a culture of continuous improvement in manufacturing operations. Act as the point person for production issues during customer visits, audits, and inspections. Qualifications and Experience Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical) or equivalent. 5+ years of experience in medical device production/manufacturing, preferably active devices. Strong knowledge of production planning, assembly/test operations, and GMP compliance . Hands-on experience with process validation, equipment qualification, and cleanroom manufacturing . Familiarity with ISO 13485:2016, FDA QSR (21 CFR Part 820), EU MDR, and ISO 14971. Proven ability to lead teams , solve production problems, and ensure regulatory compliance in manufacturing. Key Competencies Production floor leadership with strong operational discipline . Knowledge of lean manufacturing and continuous improvement methodologies. Ability to balance throughput, cost control, and compliance . Strong interpersonal and problem-solving skills to manage cross-functional challenges.
Role Overview We are looking for a detail-oriented and hands-on Assemble Engineer to support the production, assembly, testing, and integration of medical devices and hardware systems. The role involves working closely with the production and R&D teams to assemble electronic and hardware components, ensure quality standards, troubleshoot issues, and contribute to continuous improvements in assembly processes. Key Responsibilities Assemble electronic, hardware, and electro-mechanical components of medical devices as per design drawings, schematics, and SOPs. Perform PCB assembly, soldering, wiring, cabling, and connector integration . Assemble and integrate optical, electronic, and mechanical modules into final device builds. Conduct functional and quality testing on assembled units to ensure compliance with defined standards. Maintain production records, assembly checklists, and test reports . Troubleshoot and resolve assembly issues in coordination with R&D/Engineering teams. Follow ESD protocols, cleanroom practices, and Good Manufacturing Practices (GMP) . Support prototype builds, pilot production, and scaling to manufacturing . Ensure safety, calibration, and upkeep of tools/equipment used in assembly. Collaborate with cross-functional teams (Production, QA, R&D) to improve assembly efficiency and quality. Qualifications & Experience Diploma / Bachelor’s degree in Electronics, Electrical, Mechatronics, or related field . 2–4 years of hands-on experience in electronics/hardware assembly (medical devices preferred). Skilled in PCB handling, soldering, wiring, and assembling electronic modules . Familiarity with mechanical fitting, optical alignment, or device integration is an advantage. Knowledge of ISO 13485, GMP, and medical device quality requirements desirable. Strong attention to detail, good documentation practices, and teamwork mindset. Key Competencies Hands-on assembly skills (electronics + hardware). Ability to read schematics, wiring diagrams, and CAD drawings . Troubleshooting mindset and problem-solving skills. Willingness to work in a fast-paced startup environment with flexibility and ownership.
The Production Lead will oversee end-to-end manufacturing operations for active medical devices (USFDA Approved), ensuring smooth, efficient, and cost-effective production while maintaining compliance with ISO 13485:2016, FDA QSR (21 CFR Part 820), EU MDR, and GMP requirements. While regulatory submissions are handled separately, this role ensures production-level compliance, process validation, and continuous improvement in the shop floor environment. Key Responsibilities Production Management Plan and execute daily/weekly/monthly production schedules aligned with demand forecasts. Manage assembly, integration, and testing of active medical devices to meet quality and delivery commitments. Ensure cleanroom operations and adherence to production SOPs. Drive equipment qualification and process validation (IQ, OQ, PQ) at the production floor. Monitor and improve key production metrics: yield, first-pass success rate, downtime, scrap rate, and productivity . Ensure timely availability of materials, spares, and consumables by coordinating with supply chain. Support design transfer to production , ensuring prototypes scale effectively into full manufacturing. Production-Level Compliance & Quality Ensure production floor compliance with ISO 13485, GMP, and device master record (DMR)/device history record (DHR) requirements. Oversee in-process quality checks , functional testing, and batch release readiness. Implement CAPA, change control, and training programs for production teams. Collaborate with QA to ensure timely audit readiness , focusing on production-level practices. Maintain production documentation, validation records, and traceability. Team & Leadership Supervise production staff, technicians, and line engineers. Train and mentor the production team on good documentation practices (GDP), cleanroom behavior, and regulatory compliance . Drive a culture of continuous improvement in manufacturing operations. Act as the point person for production issues during customer visits, audits, and inspections. Qualifications and Experience Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical) or equivalent. 5+ years of experience in medical device production/manufacturing, preferably active devices. Strong knowledge of production planning, assembly/test operations, and GMP compliance . Hands-on experience with process validation, equipment qualification, and cleanroom manufacturing . Familiarity with ISO 13485:2016, FDA QSR (21 CFR Part 820), EU MDR, and ISO 14971. Proven ability to lead teams , solve production problems, and ensure regulatory compliance in manufacturing. Key Competencies Production floor leadership with strong operational discipline . Knowledge of lean manufacturing and continuous improvement methodologies. Ability to balance throughput, cost control, and compliance . Strong interpersonal and problem-solving skills to manage cross-functional challenges.
The Production Lead will oversee end-to-end manufacturing operations for active medical devices (USFDA Approved), ensuring smooth, efficient, and cost-effective production while maintaining compliance with ISO 13485:2016, FDA QSR (21 CFR Part 820), EU MDR, and GMP requirements. While regulatory submissions are handled separately, this role ensures production-level compliance, process validation, and continuous improvement in the shop floor environment. Key Responsibilities Production Management Plan and execute daily/weekly/monthly production schedules aligned with demand forecasts. Manage assembly, integration, and testing of active medical devices to meet quality and delivery commitments. Ensure cleanroom operations and adherence to production SOPs. Drive equipment qualification and process validation (IQ, OQ, PQ) at the production floor. Monitor and improve key production metrics: yield, first-pass success rate, downtime, scrap rate, and productivity . Ensure timely availability of materials, spares, and consumables by coordinating with supply chain. Support design transfer to production , ensuring prototypes scale effectively into full manufacturing. Production-Level Compliance & Quality Ensure production floor compliance with ISO 13485, GMP, and device master record (DMR)/device history record (DHR) requirements. Oversee in-process quality checks , functional testing, and batch release readiness. Implement CAPA, change control, and training programs for production teams. Collaborate with QA to ensure timely audit readiness , focusing on production-level practices. Maintain production documentation, validation records, and traceability. Team & Leadership Supervise production staff, technicians, and line engineers. Train and mentor the production team on good documentation practices (GDP), cleanroom behavior, and regulatory compliance . Drive a culture of continuous improvement in manufacturing operations. Act as the point person for production issues during customer visits, audits, and inspections. Qualifications and Experience Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical) or equivalent. 5+ years of experience in medical device production/manufacturing, preferably active devices. Strong knowledge of production planning, assembly/test operations, and GMP compliance . Hands-on experience with process validation, equipment qualification, and cleanroom manufacturing . Familiarity with ISO 13485:2016, FDA QSR (21 CFR Part 820), EU MDR, and ISO 14971. Proven ability to lead teams , solve production problems, and ensure regulatory compliance in manufacturing. Key Competencies Production floor leadership with strong operational discipline . Knowledge of lean manufacturing and continuous improvement methodologies. Ability to balance throughput, cost control, and compliance . Strong interpersonal and problem-solving skills to manage cross-functional challenges.
Company Description Adiuvo Diagnostics is a techno-social enterprise focused on developing state-of-the-art platform technologies in optoelectronics. Our mission is to aid early disease detection and to enable advanced healthcare diagnostics in low-resource settings. We strive to bring cutting-edge diagnostic technologies to the places they are needed most. Job Description We are seeking a highly driven Principal Engineer & Head of R&D (Hardware & Optics) to lead the development of next-generation medical diagnostic devices. This role requires a unique blend of hands-on technical expertise, cross-disciplinary knowledge, and leadership skills. The ideal candidate will not only design and execute cutting-edge R&D projects but also build and mentor a strong engineering team to deliver seamless innovation from concept to commercialization. Key Responsibilities Lead end-to-end R&D activities in hardware, optical systems, and device integration. Design, prototype, and validate novel hardware and optics solutions for imaging and diagnostic platforms. Translate product requirements into scalable technical designs in close collaboration with software, clinical, and regulatory teams. Build, guide, and mentor a multi-disciplinary team, fostering a culture of innovation and accountability. Oversee data-driven design decisions, ensuring precision, robustness, and compliance with regulatory standards. Drive experimental design, testing, and validation, including wet-lab support and cross-functional collaborations. Develop and maintain documentation required for regulatory submissions (FDA, CE, CDSCO). Manage project timelines, resource planning, and vendor coordination while staying hands-on with technical problem solving. Represent R&D leadership in discussions with external partners, investors, and collaborators. Key Qualifications Master’s or PhD in Electronics, Optics, Physics, Biomedical Engineering, or related field. Strong technical expertise in hardware systems, optical instrumentation, sensors, and imaging technologies. Proven experience in leading experimental design, prototyping, and lab-based validation. Ability to manage and mentor engineers/scientists, while remaining hands-on in solving complex technical problems. Familiarity with regulatory documentation (e.g., ISO 13485, IEC 60601, FDA/CE submissions). Strong analytical mindset with ability to assimilate and interpret data. Excellent communication skills, with ability to collaborate across clinical, regulatory, and commercial teams. Prior experience in medical devices, diagnostics, or imaging platforms is highly desirable. Why Join Us? This is not a “manager-only” role — it is a hands-on leadership position at the heart of innovation. You will directly shape cutting-edge products, learn continuously across disciplines, and play a pivotal role in building a high-performance R&D organization.
Company Description Adiuvo Diagnostics is a techno-social enterprise focused on developing state-of-the-art platform technologies in optoelectronics. Our mission is to aid early disease detection and to enable advanced healthcare diagnostics in low-resource settings. We strive to bring cutting-edge diagnostic technologies to the places they are needed most. Job Description We are seeking a highly driven Principal Engineer & Head of R&D (Hardware & Optics) to lead the development of next-generation medical diagnostic devices. This role requires a unique blend of hands-on technical expertise, cross-disciplinary knowledge, and leadership skills. The ideal candidate will not only design and execute cutting-edge R&D projects but also build and mentor a strong engineering team to deliver seamless innovation from concept to commercialization. Key Responsibilities Lead end-to-end R&D activities in hardware, optical systems, and device integration. Design, prototype, and validate novel hardware and optics solutions for imaging and diagnostic platforms. Translate product requirements into scalable technical designs in close collaboration with software, clinical, and regulatory teams. Build, guide, and mentor a multi-disciplinary team, fostering a culture of innovation and accountability. Oversee data-driven design decisions, ensuring precision, robustness, and compliance with regulatory standards. Drive experimental design, testing, and validation, including wet-lab support and cross-functional collaborations. Develop and maintain documentation required for regulatory submissions (FDA, CE, CDSCO). Manage project timelines, resource planning, and vendor coordination while staying hands-on with technical problem solving. Represent R&D leadership in discussions with external partners, investors, and collaborators. Key Qualifications Masters or PhD in Electronics, Optics, Physics, Biomedical Engineering, or related field. Strong technical expertise in hardware systems, optical instrumentation, sensors, and imaging technologies. Proven experience in leading experimental design, prototyping, and lab-based validation. Ability to manage and mentor engineers/scientists, while remaining hands-on in solving complex technical problems. Familiarity with regulatory documentation (e.g., ISO 13485, IEC 60601, FDA/CE submissions). Strong analytical mindset with ability to assimilate and interpret data. Excellent communication skills, with ability to collaborate across clinical, regulatory, and commercial teams. Prior experience in medical devices, diagnostics, or imaging platforms is highly desirable. Why Join Us This is not a manager-only role it is a hands-on leadership position at the heart of innovation. You will directly shape cutting-edge products, learn continuously across disciplines, and play a pivotal role in building a high-performance R&D organization. Show more Show less
Job Description – Financial Controller (Head) Companies: Teralumen, Ayur.AI, and Adiuvo Diagnostics Pvt. Ltd. Location: SIPCOT, Chennai Employment Type: Full-time (Monday–Saturday, 2nd & 4th Saturday off) Experience Required: 3–5 years in Accounting/Finance Qualification: Chartered Accountant (CA) – Mandatory About the Group Teralumen, Ayur.AI, and Adiuvo Diagnostics are deep-tech and healthcare-focused companies driving innovation across integrative medicine, medical diagnostics, and advanced technologies. We are seeking a Financial Controller (Head) to oversee the financial health, compliance, and governance across all three entities. Role Summary The Financial Controller will be responsible for financial reporting, compliance, planning, and investor interactions across the group. The role requires a strategic thinker with hands-on expertise in accounting, taxation, audits, and financial control. The individual will work closely with management and boards of all three companies to ensure transparency, efficiency, and regulatory adherence. Key Responsibilities Financial Reporting & Analysis Prepare monthly MIS, profit center–wise budgets, and annual financial statements. Conduct financial analysis to track variances and highlight opportunities for optimization. Consolidate financial reports across the three companies and present to management/board. Statutory Compliance & Audits Ensure compliance with GST, TDS, Income Tax, Companies Act, and other applicable laws. Coordinate with external auditors and company secretaries to complete audits and filings on time. Stay updated on regulatory changes and implement process updates as required. Budgeting & Forecasting Lead annual budgeting and periodic forecasting for each company. Monitor actuals vs. budgets and recommend corrective measures. Financial Planning & Strategy Support management in capital structure planning, fundraising, and investor relations. Conduct due diligence, support valuation discussions, and prepare investor materials. Track detailed business plans and KPIs; ensure robust dashboards and reporting systems. Cash Flow & Working Capital Management Monitor daily cash flow and ensure liquidity for operations. Develop strategies for efficient working capital management. Internal Controls & Risk Management Implement and maintain strong financial controls and risk management systems. Review agreements/MoUs for financial implications before execution. Systems & Process Improvements Oversee accounting systems (Tally, financial software) and promote automation. Drive efficiency in finance operations across the three companies. Additional Responsibilities Oversee HR administration in finance-related areas (PF, payroll, insurance). Manage company assets, leases, and insurance coverage. Support administrative and vendor management where finance is involved. Any other roles as defined by the CEO/Board. Requirements Chartered Accountant (CA) with 3–5 years of relevant experience. Strong knowledge of Indian Accounting Standards, taxation, and compliance. Experience in financial reporting, audits, investor communication, and fundraising support. High attention to detail, strong analytical ability, and business acumen. Strong communication skills and ability to manage finance across multiple companies.
Company: Adiuvo Diagnostics Pvt. Ltd. www.adiuvodiagnostics.com Job Title: Quality Control Engineer About Us: Adiuvo Diagnostics is a deep-tech medical startup developing next-generation diagnostic solutions. Our interdisciplinary team combines expertise in optics, electronics, microbiology, and artificial intelligence to create innovative point-of-care medical technologies. Role Summary: We are looking for a dedicated and detail-oriented Quality Control Engineer to ensure the quality and compliance of materials, components, and products sourced from suppliers. The role will focus on supplier quality assurance, raw material validation, and robust incoming inspection processes to ensure our diagnostic solutions consistently meet regulatory and customer requirements. Key Responsibilities Supplier Quality Management Evaluate and qualify suppliers to ensure adherence to company and regulatory quality standards. Conduct supplier audits and drive corrective actions for non-conformances. Monitor supplier performance and maintain compliance records. Incoming Material & Component Inspection Establish inspection criteria, sampling plans, and acceptance standards for raw materials and components. Perform and oversee incoming inspections using precision instruments (calipers, micrometers, gauges, spectrometers, etc.). Document non-conformances and coordinate with suppliers for corrective and preventive actions. Quality Systems & Compliance Ensure compliance with ISO 13485, ISO 9001, and medical device regulatory standards. Maintain accurate inspection records, certificates of analysis, and quality reports. Participate in risk assessment, root cause analysis, and CAPA processes. Cross-Functional Collaboration Work closely with Procurement, R&D, and Manufacturing teams to resolve supplier-related quality issues. Support new product development by validating supplier materials and components. Train team members on inspection methods and quality best practices. Required Skills & Experience Bachelor’s degree in Mechanical, Electronics, Biomedical, or Industrial Engineering (or related field). 2–5 years of experience in supplier quality control, incoming inspection, or QC roles , preferably in medical devices, electronics, or precision manufacturing. Strong knowledge of quality tools : 8D, RCA, CAPA, FMEA, and statistical process control. Hands-on experience with measurement and testing instruments. Familiarity with ISO 13485 / ISO 9001 quality management systems. Strong analytical and communication skills; ability to work cross-functionally. Nice to Have Prior experience in medical devices, diagnostics, or regulated industries . Exposure to regulatory requirements (e.g., CE, FDA, IVD). Knowledge of supplier development programs and lean quality systems.
Company Description Adiuvo Diagnostics is a techno-social enterprise focused on developing cutting-edge platform technologies in optoelectronics. Our mission is to effectively aid in early disease detection and enable advanced healthcare diagnostics in low-resource settings. We are committed to improving healthcare access and outcomes through innovative solutions. Role Description This is a full-time, on-site role for a Mechanical Design Intern located in Chennai. The intern will be responsible for assisting in the design and development of mechanical components and systems, utilizing computer-aided design (CAD) software. Day-to-day tasks include performing maintenance, conducting mechanical inspections, and supporting automotive mechanical engineering projects. Collaboration with the engineering team to ensure design accuracy and functionality is key in this role. Qualifications Proficiency in Mechanical Engineering and Automotive projects Experience with Computer-Aided Design (CAD) software Skills in performing maintenance and conducting inspections Familiarity with fabrication methods such as FDM printing, SLA printing etc. Strong problem-solving and analytical skills Ability to work on-site in Chennai Bachelor's degree in Mechanical Engineering or a related field (in progress or completed) Excellent teamwork, communication skills for active interaction with vendors.
About Us: Adiuvo Diagnostics is a deep-tech medical technology company developing next-generation diagnostic platforms that integrate optics, electronics, and artificial intelligence to enable rapid, non-invasive detection of infections at the point of care. Our interdisciplinary team brings together expertise in engineering, biology, and computational sciences to transform diagnostics globally. Role Summary: We are looking for a hands-on R&D leader to drive the research, design, and development of Adiuvo’s diagnostic technologies. The role demands a balance between technical depth and practical product realization — someone who can architect systems, mentor engineers, and personally contribute to design, prototyping, and problem-solving. While medical device experience is an advantage, it is not mandatory ; an adaptable engineer with a strong foundation in electronics, optics, and mechanical design will excel with domain training. Key Responsibilities: Lead end-to-end product design and development from concept to design transfer. Provide technical direction in electronics, optics, and system integration . Ensure robust design control and documentation aligned with ISO 13485 standards. Oversee verification and validation testing, ensuring design intent and reliability. Guide the team in translating research prototypes into manufacturable, scalable products. Collaborate with Quality, Manufacturing, and Clinical Affairs for design transfer and regulatory readiness. Mentor a multidisciplinary team of engineers and researchers. Evaluate new technologies and contribute to the long-term R&D roadmap. Required Skills & Experience: Ph.D. or Master’s degree in Electronics, Instrumentation, Optics, Biomedical, or related engineering discipline. Minimum 8+ years in product R&D, preferably in medical devices, diagnostics, or high-precision systems . Strong knowledge of electronic circuit design, embedded systems, and optical subsystems . Working understanding of mechanical design, assembly, and manufacturability principles . Experience in ISO 13485-driven product development , including design verification, validation, and risk management. Demonstrated record of hands-on problem-solving and guiding cross-functional engineering teams. Preferred Attributes: Experience in medical device or diagnostic system development . Familiarity with optical imaging, spectroscopy, or sensor integration . Understanding of CE/FDA/IVD regulatory requirements . A “builder mindset” — technical leadership through doing, not just managing. What We Offer: A chance to lead innovation at the intersection of optics, electronics, and AI. A collaborative, interdisciplinary environment with direct impact on healthcare outcomes. Competitive compensation and opportunity for long-term growth with the company.
Role Overview: As the Senior Assembly Engineer at Adiuvo Diagnostics Private Limited in Vishakhapatnam, AMTZ Unit, your main responsibility will involve the assembly, integration, and quality control of optical, electronic, and mechanical components used in advanced diagnostic devices. Your expertise in hands-on assembly, PCB soldering, optical alignment, and QA/QC procedures will play a crucial role in ensuring compliance with ISO 13485:2016 and GMP standards. Key Responsibilities: - Assemble, align, and integrate optical components, lenses, and precision mechanical parts to meet design specifications. - Ensure accurate positioning and calibration of optical paths. - Perform manual and automated PCB assembly, ensuring proper component placement and secure connections. - Soldering (SMD & through-hole) of electronic components with precision and adherence to industry standards. - Assemble complete diagnostic devices, ensuring all components (optical, electronic, and mechanical) function seamlessly. - Troubleshoot and resolve any assembly-related issues. - Conduct thorough inspections and functional testing of assembled units. - Identify defects and ensure compliance with quality standards. - Follow Good Manufacturing Practices (GMP) and ISO 13485:2016 for medical device assembly. - Maintain proper documentation for audits and regulatory compliance. - Maintain and calibrate assembly tools, soldering equipment, and optical alignment systems. - Ensure proper handling of ESD-sensitive components. - Identify and implement improvements in assembly efficiency, product reliability, and defect reduction. - Coordinate with R&D, design, and production teams to ensure a smooth assembly workflow. - Provide technical support to production and junior technicians. - Guide and train junior engineers/technicians in assembly best practices. Qualifications & Skills: - Diploma/Bachelors Degree in Electronics, Electrical, Mechanical, or Optical Engineering (or related field). - 3+ years of hands-on experience in optical, electronic, and PCB assembly. - Strong knowledge of PCB soldering (SMD & through-hole), optical alignment, and precision mechanical assembly. - Experience with QA/QC inspections, testing procedures, and ISO 13485:2016 compliance. - Ability to troubleshoot and optimize assembly processes. - Hands-on experience with microscopes, reflow ovens, soldering stations, and ESD protection. - Excellent problem-solving skills, attention to detail, and teamwork. Preferred Qualifications: - Prior experience in medical device manufacturing or regulated industries. - Knowledge of automated assembly equipment and process automation.,
About Us: Adiuvo Diagnostics is a deep-tech medical technology company developing next-generation diagnostic platforms that integrate optics, electronics, and artificial intelligence to enable rapid, non-invasive detection of infections at the point of care. Our interdisciplinary team brings together expertise in engineering, biology, and computational sciences to transform diagnostics globally. Role Summary: We are looking for a hands-on R&D leader to drive the research, design, and development of Adiuvo's diagnostic technologies. The role demands a balance between technical depth and practical product realization someone who can architect systems, mentor engineers, and personally contribute to design, prototyping, and problem-solving. While medical device experience is an advantage, it is not mandatory ; an adaptable engineer with a strong foundation in electronics, optics, and mechanical design will excel with domain training. Key Responsibilities: Lead end-to-end product design and development from concept to design transfer. Provide technical direction in electronics, optics, and system integration . Ensure robust design control and documentation aligned with ISO 13485 standards. Oversee verification and validation testing, ensuring design intent and reliability. Guide the team in translating research prototypes into manufacturable, scalable products. Collaborate with Quality, Manufacturing, and Clinical Affairs for design transfer and regulatory readiness. Mentor a multidisciplinary team of engineers and researchers. Evaluate new technologies and contribute to the long-term R&D roadmap. Required Skills & Experience: Ph.D. or Master's degree in Electronics, Instrumentation, Optics, Biomedical, or related engineering discipline. Minimum 8+ years in product R&D, preferably in medical devices, diagnostics, or high-precision systems . Strong knowledge of electronic circuit design, embedded systems, and optical subsystems . Working understanding of mechanical design, assembly, and manufacturability principles . Experience in ISO 13485-driven product development , including design verification, validation, and risk management. Demonstrated record of hands-on problem-solving and guiding cross-functional engineering teams. Preferred Attributes: Experience in medical device or diagnostic system development . Familiarity with optical imaging, spectroscopy, or sensor integration . Understanding of CE/FDA/IVD regulatory requirements . A builder mindset technical leadership through doing, not just managing. What We Offer: A chance to lead innovation at the intersection of optics, electronics, and AI. A collaborative, interdisciplinary environment with direct impact on healthcare outcomes. Competitive compensation and opportunity for long-term growth with the company.
Company Description Adiuvo Diagnostics is a techno-social enterprise focused on developing state-of-the-art platform technologies in optoelectronics. Our mission is to aid early disease detection and to enable advanced healthcare diagnostics in low-resource settings. We strive to bring cutting-edge diagnostic technologies to the places they are needed most. Job Description We are seeking a highly driven Principal Engineer & Head of R&D (Hardware & Optics) to lead the development of next-generation medical diagnostic devices. This role requires a unique blend of hands-on technical expertise, cross-disciplinary knowledge, and leadership skills. The ideal candidate will not only design and execute cutting-edge R&D projects but also build and mentor a strong engineering team to deliver seamless innovation from concept to commercialization. Key Responsibilities Lead end-to-end R&D activities in hardware, optical systems, and device integration. Design, prototype, and validate novel hardware and optics solutions for imaging and diagnostic platforms. Translate product requirements into scalable technical designs in close collaboration with software, clinical, and regulatory teams. Build, guide, and mentor a multi-disciplinary team, fostering a culture of innovation and accountability. Oversee data-driven design decisions, ensuring precision, robustness, and compliance with regulatory standards. Drive experimental design, testing, and validation, including wet-lab support and cross-functional collaborations. Develop and maintain documentation required for regulatory submissions (FDA, CE, CDSCO). Manage project timelines, resource planning, and vendor coordination while staying hands-on with technical problem solving. Represent R&D leadership in discussions with external partners, investors, and collaborators. Key Qualifications Master’s or PhD in Electronics, Optics, Physics, Biomedical Engineering, or related field. Strong technical expertise in hardware systems, optical instrumentation, sensors, and imaging technologies. Proven experience in leading experimental design, prototyping, and lab-based validation. Ability to manage and mentor engineers/scientists, while remaining hands-on in solving complex technical problems. Familiarity with regulatory documentation (e.g., ISO 13485, IEC 60601, FDA/CE submissions). Strong analytical mindset with ability to assimilate and interpret data. Excellent communication skills, with ability to collaborate across clinical, regulatory, and commercial teams. Prior experience in medical devices, diagnostics, or imaging platforms is highly desirable. Why Join Us? This is not a “manager-only” role — it is a hands-on leadership position at the heart of innovation. You will directly shape cutting-edge products, learn continuously across disciplines, and play a pivotal role in building a high-performance R&D organization.
Role Overview: Adiuvo Diagnostics is looking for a highly motivated Principal Engineer & Head of R&D (Hardware & Optics) to spearhead the development of advanced medical diagnostic devices. As the ideal candidate, you will lead a talented team in designing and implementing innovative solutions from conception to market launch. Key Responsibilities: - Lead end-to-end research and development efforts in hardware, optical systems, and device integration. - Design, prototype, and validate new hardware and optics solutions for imaging and diagnostic platforms. - Collaborate closely with software, clinical, and regulatory teams to translate product requirements into scalable technical designs. - Foster innovation and accountability within the engineering team through mentorship and guidance. - Ensure precision, robustness, and compliance with regulatory standards in all data-driven design decisions. - Drive experimental design, testing, and validation processes, including wet-lab support and cross-functional collaborations. - Prepare and maintain necessary documentation for regulatory submissions such as FDA, CE, CDSCO. - Manage project timelines, resource allocation, and vendor relationships while actively engaging in technical issue resolution. - Represent R&D leadership in engagements with external partners, investors, and collaborators. Key Qualifications: - Masters or PhD in Electronics, Optics, Physics, Biomedical Engineering, or a related field. - Proficiency in hardware systems, optical instrumentation, sensors, and imaging technologies. - Demonstrated leadership in experimental design, prototyping, and laboratory-based validation. - Ability to lead and mentor a team of engineers and scientists while actively participating in solving complex technical challenges. - Familiarity with regulatory documentation standards like ISO 13485, IEC 60601, and FDA/CE submissions. - Strong analytical skills with the ability to analyze and interpret data effectively. - Excellent communication skills to collaborate with clinical, regulatory, and commercial teams. - Previous experience in medical devices, diagnostics, or imaging platforms is advantageous. (Note: No additional company details were mentioned in the provided job description.),
About Us: Adiuvo Diagnostics is a deep-tech medtech company building next-generation diagnostic platforms that integrate optics, electronics, and AI to enable rapid, non-invasive infection detection at the point of care. Role Summary: We're seeking a Ph.D.-level Photonics Scientist to drive optical design, imaging, and system integration for Adiuvo's diagnostic technologies. The ideal candidate combines deep expertise in optics and photonics with practical experience in developing real-world hardware for biomedical or analytical systems. Key Responsibilities: Lead the design, prototyping, and optimization of optical subsystems (illumination, imaging, spectroscopy). Develop and implement optical architectures that interface with electronics and embedded systems. Conduct simulations, optical modeling, and experimental validation of optical setups. Collaborate with electronics, mechanical, and software teams to achieve system-level integration. Contribute to design documentation, verification, and regulatory readiness (ISO 13485 environment). Evaluate emerging optical technologies to shape the company's product roadmap. Requirements: Ph.D. in Photonics, Optics, or Applied Physics (mandatory). Prior R&D experience in imaging, spectroscopy, or optical sensing systems. Experience integrating optics with electronics and mechanical assemblies. Proven ability to take optical systems from lab prototype to product.