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Job Discretion: JL 5 - Sr Associate role - Electrical or Mechanical Engineering with 5+ years of experience . 3+ relevant years of experience in Design Control of Medical Devices . Life cycle management, making decisions in change management. Change management - Cost reduction, process improvement. Regulatory affairs MDR to EMUDR , follow the regulatory & statutory requirements Work with cross functional teams. Excellent written & verbal communication. Act as project lead – coordinate with different teams - Design Control , MTO, Service, Regulatory Affairs . Team lead experience. Good to have experience in ophthalmology . Consumables and Accessories experience. People with experience in Sterile Barrier/Packaging, Biocompatibility, and sterilization . They have min understanding of it.

Role/Summary: Collaborate with cross-functional teams to identify and assess risks associated with medical device development and integrate risk management activities into the V&V process, ensuring that potential hazards and risks are adequately addressed and mitigated in accordance with ISO 14971. Utilize risk-based testing methodologies to prioritize V&V activities based on the level of risk associated with medical devices. Evaluate the effectiveness of risk controls and mitigation strategies through V&V testing activities. Develop verification and validation protocols and test plans based on product requirements, design specifications, and regulatory standards. Document and maintain comprehensive records of V&V activities, including test results, deviations, and corrective actions taken. Ensure that V&V activities are integrated into the product development lifecycle and are compliant with regulatory requirements. Ensure compliance requirements according to ISO 13485, CDSCO and EU MDR, ISO 14971 and other applicable regulations and standards. Prepare and maintain V&V documentation for regulatory submissions, including technical files and design dossiers. Experience with complete DHF development. Job Responsibility: Performs the role of a Verification Lead Provide technical guidance, review support to the test team( manual and automation). Support & train test engineers on process/domain Formulate the test strategy for a product/subsystem including test automation Participates in Review of test deliverable. Handle the estimation, planning , resource identification and risk management activities related to test automation. Lead and participate in automation test case development, review, execution, reporting and traceability. Ownership of completeness of all test documents Manages technical communication within team and partners/stakeholders Participates in improvement initiatives to enhance productivity Drive the automation work within the team & aim to achieve committed automation coverage Ownership of Test deliverable for the scope of work responsible Mentor the junior testers on automation as Subject Matter Expert (SME). Provide status update to management on overall Verification progress Behavioral Competencies: Firm decision maker and shall possess good influencing skills Openness to collaborate in interest of project/organization Proactive and self-driven, possesses due sense of urgency Integrity & Corporate Values: Best in Class Is focused on Quality, and works with a mindset of continuous improvement Integrity – The job should be performed with the value of honesty, good principles, fairness and maintain confidentiality Open to Change – to have a creative mindset while performing one’s job, explore new processes and procedures to increase efficiency and effectiveness Respect - Gives respect in communication, work, collaboration with internal as well as external customers Alliance – Maintains timelines, understands the role one’s department plays across a larger picture, hence standing by commitments made to the team, other departments, vendors and external customers Diversity – Welcomes diversity as a stepping stone to innovation and builds stronger bonds with people to deliver better and more comprehensive results.

Role & responsibilities 1. Hands on experience in design controls requirements in medical device industry 2. Design verification, Design Outputs etc. 3. Experience developing test protocols and test plans 4. Strong Communication (written & verbal). 5. Ability to collaborate effectively with cross-functional teams 6. Knowledge in PLM/ALM tools (SAP, Team Centre, Windchill, etc.) 7. Technical knowledge of engineering statistics (Minitab Preferred)

Educational Requirements Master Of Engineering,MTech,Bachelor of Engineering,BTech Service Line Engineering Services Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide your teams towards developing optimized high quality code deliverables, continual knowledge management and adherence to the organizational guidelines and processes. You would be a key contributor to building efficient programs/ systems and if you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you!If you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you! Technical and Professional Requirements: Primary Skills: CTQ, QMS, ISO 13485, Design Documentation, CAPA, DHF Preferred Skills: Technology->CAD->CAD - Others

Join a team that values innovation, growth, and impactful work. Don't miss the chance to work with cutting-edge projects in SME and be a part of something transformative! Drive Date: 26th July Saturday (9AM-2PM) Skills Required: - Experience in DHF remediation - Proficiency in Design Control, Design Verification, and Design Validation - Expertise in WindchillPLM in the medical domain Venue Location: HCLTech Elcot Sez, New Cafeteria 2nd Floor, 602/3, 138, Medavakkam High Road, Sholinganallur, Chennai-600119 Position: Mechanical Design (Lead, Technical Lead) Experience: 2.5-10 years Job Location: Chennai Job Description: - B.E / B.Tech or higher education in Mechanical Engineering - Sustaining Engineers should have 3 to 7 years of experience in Medical Device Design Controls, Design Verification & Validation - Proficient in Design Control processes for Medical Devices - Led Change Qualification projects for medical devices, working with multi-cultured CFT - Experience in developing test protocols and test plans - Ensures quality of deliverables, including design, data summary and interpretation, and report generation - Expertise in Mechanical Engineering basics - Proficient in Risk Management (Proactive risk identification and mitigation planning) - Self-motivated and capable of working independently with strong project management skills - Knowledge of ISO13485 would be an added advantage - Excellent Oral and written Communication skills with proven Technical writing skills and interpersonal skills Software Tools: - SolidWorks, 2D Tolerance Stackup, MS Word/Excel/PowerPoint Skill 2 Job Description (DHF Remediation): - Experience in gap assessment processes such as Testing gap assessment, Standards gap assessment, Requirements gap assessment - Knowledge in Design History File remediation Skill 3 Job Description (WindchillPLM - Medical Domain): - Proficiency in WindchillPLM in the medical domain, BOM structure, and Change order process Interested candidates can share their CV to Katherinesylvia.k@hcltech.com with the following details: Current Company, Current CTC, Expected CTC, Notice Period, Location. CONSIDER THIS AS CALL LETTER,

Additional Locations: India-Haryana, Gurgaon Diversity Innovation Caring Global Collaboration Winning Spirit High Performance At Boston Scientific, well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges With access to the latest tools, information and training, well help you in advancing your skills and career Here, youll be supported in progressing whatever your ambitions, Key Responsibilities Read and interpret technical drawings, procedures, and protocols, Import and maintains the project documentation in online RM tool throughout all phases of NPD and Sustaining, Investigates and evaluates the compliance requirements driven from organizations QMS/Work Instructions and validate the same in templates developed in RM tool, Investigates and evaluates existing RM tools/technologies JAMA, Polarion, Cockpit etc Investigates compliance gaps in project documents and resolve them with project stake holders Collaborate with cross-functional process, method, and teams to understand and implement solutions to resolve compliance gap issues in documents, Performs validation of patches and versions of RM tool as and when available, Support multiple projects across different time zones Asia, Ireland, and North America Qualifications Required Mechanical Engineering ( B E /b-tech) with 4-5 years of experience Preferred experience in management of DHF documentation during full life cycle of medical device as per ISO 13485, and ISO 14971 Preferred experience in RM tools like JAMA, Polarion, DOORS, Cockpit Knowledge of MS Office Tools Word, Excel, PowerPoint, Strong attention to detail with good communication skills, Strong strategic / analytical thinking and problem-solving abilities, with a data-driven approach to decision-making, Ability to collaborate and work as a team player, Nice to have experience in product lifecycle management software and tools, Willingness to work in an agile environment, Requisition ID: 610104 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most united by a deep caring for human life Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate Now more than ever, we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen, So, choosing a career with Boston Scientific (NYSE: BSX) isnt just business, its personal And if youre a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! Show

Develop & operate the Pilot plant from the R&D lab trial data till Commissioning of the Plant setup Ensure the production plant is working within the targeted norms, Safety & quality scales Continue implementation of IMS & PSM practices of the plant Required Candidate profile BE CHEMICAL ENGG 3+yrs exp into MAINT/NEW PROJECTS/NPD/ROCESS with CHEMICAL Unit Exposure in HYDRO FLURIC ACID, HYDROFLUOROCARBON REFRIGERANTS, SPECIALTY ORGANIC FLUORIDES etc ++++ Work @ CUDDALORE Perks and benefits cv.ch1@adonisstaff.in Call @ 9677076683 now

As a Medical Mechanical Design Verification/Control Engineer at HCLTech in Chennai Shollinganallur, you will be joining a team that values innovation, growth, and impactful work. This is an opportunity to work on cutting-edge projects in SME and be a part of something transformative! The walk-in drive is scheduled for 21st July Saturday from 9AM to 2PM at HCLTech Elcot Sez, 602/3, 138, Medavakkam High Road, Sholinganallur, Chennai-600119. The position available is for Mechanical Design (Lead, Technical Lead /Sr Lead) with an experience requirement of 3-7 years. To be eligible for this role, you should have a B.E/B.Tech or higher education in Mechanical Engineering. Sustaining Engineers are expected to have experience in Medical Device Design Controls, Design Verification & Validation for 3 to 7 years. You should be adept with the Design Control process for Medical Devices and have led Change Qualification projects for medical devices, collaborating with multi-cultured CFT. Your responsibilities will include developing test protocols and test plans, ensuring the quality of deliverables, expertise in Mechanical Engineering basics, Risk Management, applying statistical methods to problem-solving, and driving solutions for technical issues. Additionally, you should be self-motivated, capable of working independently, possess strong project management skills, and have excellent oral and written communication skills including technical writing. Knowledge of ISO13485 would be an added advantage for this role. Proficiency in software tools such as SolidWorks, 2D Tolerance Stackup, MS Word/Excel/PowerPoint is required. Interested candidates can share their CV with Katherine Sylvia at Katherinesylvia.k@hcltech.com, including details such as Current Company, Current CTC, Expected CTC, Notice Period, and Location. Make sure to bring this call letter for the walk-in interview on 21st July.,

As a Design Quality Engineer at our company, your primary responsibility will be to develop, establish, and maintain quality engineering methodologies, systems, and practices that align with BSC, customer, and regulatory requirements. You will serve as a Quality representative to enhance awareness, visibility, and communication on quality initiatives, supporting departmental, functional, site, divisional, and corporate quality goals and priorities. Your role will involve providing focused quality engineering support within new product development, operational, or system/services support. In this position, you will collaborate with sustaining project teams and engage in design quality engineering throughout the entire product cycle. Your duties will include ensuring the creation and proper execution of Project/Sustaining Quality Deliverables, such as Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan. Additionally, you will work on product Design History File (DHF), design input, design output, product risk management, usability, verification, and validation efforts for commercial products. Furthermore, you will be responsible for managing electronic document control and version control on all project-related documents, ensuring adherence to quality systems and design assurance Standard Operating Procedures (SOPs), and providing quality and regulatory compliance guidance to product development or design change project teams. You will lead the implementation of assurances, process controls, and Corrective and Preventive Action (CAPA) systems to meet or exceed internal and external requirements. As an effective communicator and team member, you will support quality disciplines, decisions, and practices while applying sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues. Your role will also involve assisting in the development and execution of streamlined business systems to effectively identify and address quality issues. In all your actions, you will demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures. As a Design Quality Engineer, you will be expected to have expanded conceptual and technical knowledge in the Medical Device Design Quality domain, broaden your capabilities in applying concepts in your job function, demonstrate working knowledge of business and industry practices, and company processes to accomplish your work. You will be accountable for your contributions and meeting objectives, with no supervisory responsibility. Your role will involve planning and organizing non-routine tasks with approval, initiating or maintaining work schedule and priorities, organizing project assignments, and maintaining project schedules. You will use judgment to solve problems in straightforward situations, working under general direction from more senior-level roles or managers. Your interactions and communications will primarily involve explaining factual information of limited complexity to others in straightforward situations and organizing, presenting, and explaining data/information to internal audiences.,

HCLTech WalkInDrive In Chennai for Mechanical Engineers on 26th July Saturday. CONSIDER THIS AS CALLLETTER Medical Mechanical DHF/ windchillPLM/Design Verification/Control Engineer- WalkIN on 26th July in Chennai Shollinganallur Join a team that values innovation, growth, and impactful work. Dont miss the chance to work with cutting-edge Project in SME and be a part of something transformative! Drive Date:26th July Saturday (9AM-2PM) Skill1: #DHF #remediation #DHFremediation Skill2: #Designcontrol #designverfication #designvalidation Skill3: #WindchillPLM in medical domain Contact Person: Katherine Sylvia Venue Location: #HCLTech Elcot Sez, 602/3, 138, Medavakkam High Road, Sholinganallur, #Chennai -600119 Position:Mechanicaldesign (Lead, Technical Lead) Experience: 2.5-9 years Job Location:Chennai Skill : Medical device, Design control, Design Verification, DHF, MDR, ISO13485, Risk management, DHF Remediation, WindchillPLM #changeorder #Designhistoryfiles #JD : B.E / B.Tech or higher education in Mechanical Engineering #EXPERIENCE : Sustaining Engineers should have Medical Device #DesignControls , #Design verification & Validation experience of 3 to 7 years. Adept with #DesignControlprocess for #MedicalDevices . Led Change Qualification projects for medical devices, working with multi-cultured CFT. Experience developing test protocols and test plans Ensures quality of deliverables, including design, data summary and interpretation and report generation. Expertise in #MechanicalEngineering basics. #RiskManagement (Proactive risk identification and mitigation planning) Self-motivated and capable of working independently & Strong project management skills. Knowledge on #ISO13485 would be an added advantage. Excellent Oral and written Communication (MUST prove Technical writing skills with samples and/or assessment during the interview) & Interpersonal skills #SOFTWARETOOLS : #Mechanical #SolidWorks , #2D #ToleranceStackup , MS Word/ Excel/ Power point, #Skill2#JD : #DHFRemediation Experience in gap assessment process such as Testing gap assessment, Standards gap assessment, Requirements gap assessment Knowledge in Design History File remediation #Skill3#JD : #windchillPLM #medicaldomain #BOMstructure #Changeorder Create, Revise, Release parts (ZFIN, ZRAW, ZSMI, ZMOD, ZNVL) in Wind-chill according to the requirements defined in WI Create, Revise, Release Documents (Protocols, Reports, FAB, TRAV, PFMEA, IFU, Drawing Specification, Device tracking kit etc) in Wind-chill according to the requirements defined in WI Update Document and Part structure Create, Update BOM structure Create Change order with change description and justification for change. Assign Change Activity Assignee and Peer Reviewer. Assign approvers to the Change Implementation Board for change orders per the approval requirements. Create manual Pre- and Post-Release Adhoc Tasks Follow up with approvers to get the COs reviewed and approved Release of the Change Orders in Wind chill #Contact Person: #KatherineSylvia Interested candidates can share their CV on below mail id Katherinesylvia.k@hcltech.com with Below details Current Company, Current CTC, Expected CTC, Notice Period, Location . CONSIDER THIS AS CALLLETTER

HCLTech WalkInDrive In Chennai for Mechanical Medical Design Verification Engineer on 26th July Saturday. ( Medical Devices experience - Preferable or equalent Experience) Job Location : Chennai DriveDate :26th July Saturday (9AM-2PM) Venue Location : Chennai HCLTech Elcot Sez, New Cafeteria 2nd Floor 602/3, 138, Medavakkam High Road, Sholinganallur,hashtag Chennai -600119 Position : Mechanicaldesign (Engineer, Lead) APPLY - https://lnkd.in/gHQ5PFt6 Experience : 2.5-9 years Skill : M edical device, Design control, Design Verification, DHF, MD, Design validation ISO 13485 DHF remediation D esign history files JD : B.E / B.Tech or higher education in Mechanical Engineering EXPERIENCE : • Sustaining Engineers should have Medical Device Design Controls, Design verification & Validation experience of 3 to 5 years. • Adept with Design Control process for Medical Devices . • Led Change Qualification projects for medical devices, working with multi-cultured CFT. • Experience developing test protocols and testplans • Ensures quality of deliverables, including design, data summary and interpretation and report generation. • Expertise in MechanicalEngineering basics. • RiskManagement (Proactive risk identification and mitigation planning) • Hands-on with Computing skills (Basics of Engineering calculations). • Ability to apply statistical methods to problem solving. • Drive solutions for technical issues and convince Stakeholders on technical issues, backed up with Engineering Basics & Judgment. • Self-motivated and capable of working independently & Strong project management skills. • Knowledge on ISO13485 would be an added advantage. • Excellent Oral and written Communication (MUST prove Technical writing skills with samples and/or assessment during the interview) & Interpersonal skills SOFTWARETOOLS : Mechanical SolidWorks , 2D ToleranceStackup , MS Word/ Excel/ Power point, (Note: Software tools are for guidance only; Knowledge and experience in a fore mentioned software tools alone is not an eligibility criteria / strategy to qualify a resource). ContactPerson : Katherine Interested candidates can share their CV on below mail id Katherinesylvia.k@hcltech.com Subject Line:Application for Design Verfication Engineer- Chennai https://lnkd.in/g-H4ztQM Role & responsibilities

Join our Sustaining Engineering Team and contribute to: New Product Development (NPD) Design History File (DHF) updates Risk Management & DFMEA Verification & Validation (V&V) Design Controls Required Candidate profile Experince range 4 to 15 years only. Medical experince is must. Only immediate and serving notice period required.

Develops, establishes and maintains quality engineering methodologies, systems,practices which meet BSC,customer,regulatory requirements. Serves as a Quality representative to improve awareness,visibility,communication on quality initiatives Required Candidate profile Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.

Job Title: Senior Design Engineer Reports to: D&D Head Job Summary: The Senior Design Engineer will lead the design and development of innovative medical devices, ensuring compliance with regulatory and industry standards. This role involves mentoring junior team members, managing complex design projects, coordinating with cross-functional departments, and preparing comprehensive design documentation for regulatory submissions. The candidate must have a strong understanding of manufacturing processes, regulatory expectations, and design control principles. Key Responsibilities: 1. Design & Product Development Lead the design and development of new products and improvements to existing devices using SolidWorks and AutoCAD. Translate clinical and market requirements into functional designs while ensuring manufacturability and cost-effectiveness. Validate engineering calculations, tolerance stack-ups, and material selection for implantable devices and surgical instruments. 2. Project Leadership Plan and execute design activities in alignment with project timelines. Coordinate design reviews, risk analysis, and design verification/validation. Collaborate with the D&D Head to define design strategy and resource allocation. 3. Mentorship & Team Development Guide and mentor Junior Design Engineers in modeling, drafting, design analysis, and documentation. Review work submitted by junior staff and provide constructive feedback. 4. Manufacturing Integration Ensure designs are optimized for manufacturing processes such as CNC machining, laser marking, anodizing, and PEEK/titanium-specific considerations. Work closely with production, quality, and supply chain teams to ensure smooth handover from design to production. 5. Regulatory & Documentation Prepare and review Design History Files (DHF), Technical Files, Risk Management Reports, and Engineering Change Requests (ECRs). Ensure all designs and documentation meet CE MDR, US FDA, and CDSCO regulatory requirements. Support audits and regulatory submissions with accurate and complete documentation. 6. Design Evaluation & Predicate Comparison Conduct design benchmarking and engineering justification reports. Compare new designs against predicate or competitive devices for clinical and functional performance. 7. Innovation & Continuous Improvement Research new design trends, technologies, and surgical techniques in arthroscopy and orthopedics. Contribute to IP development, design patents, and publications where applicable. Qualifications: Education: Bachelors or Master’s degree in Mechanical, Biomedical, or Product Design Engineering. Experience: 3–6 years of experience in medical device design, preferably with exposure to orthopedic/arthroscopic implants and instruments. Skills: Advanced proficiency in SolidWorks and AutoCAD. Strong knowledge of GD&T, DFMA, FMEA, and design verification protocols. Familiarity with regulatory frameworks (CE MDR, US FDA 21 CFR 820, ISO 13485). Hands-on experience with prototype evaluation, testing fixtures, and validation tools. Good communication, leadership, and documentation skills.

Note: Qualification: B.Tech / B.E. in Biomedical Engineering, Biotechnology, or related Medical Engineering field (Pharma background (B. Pharma / M. Pharma) profiles will not be considered) Mandatory Skills: Regulatory Affairs Medical Devices EU MDR compliance Design History File (DHF) Risk Assessment & Risk Management Familiarity with ISO 13485 and other applicable standards Key Responsibilities: Prepare, review, and manage regulatory submissions for medical devices (India and international markets) Ensure compliance with EU MDR (Medical Device Regulation) and local regulatory requirements Maintain and update Design History Files (DHF) , Technical Files, and Risk Management documentation Conduct risk assessments and support implementation of risk mitigation strategies Work closely with cross-functional teams R&D, Quality Assurance, and Product Development to ensure regulatory compliance Monitor changes in medical device regulations and assess their impact on company products Interface with regulatory bodies for product approvals and audits

Purpose of the role: The Design Quality Engineer will be responsible for ensuring the design, development, and manufacturing processes comply with regulatory requirements, industry standards, and company quality policies. This role will involve close collaboration with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Quality Assurance. Roles & Responsibilities: Ensure design control activities comply with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485) and standards (e.g., ISO 14971, IEC 62366). Participate in design reviews and provide quality engineering support throughout the product development lifecycle. Establish and maintain Design History Files (DHF) and Risk Management Files (RMF). Conduct design verification and validation activities, ensuring product safety and efficacy. Develop and implement risk management activities including Failure Mode and Effects Analysis (FMEA). Collaborate with cross-functional teams to ensure effective design transfer from R&D to manufacturing. Support the creation and review of technical documentation, including design inputs/outputs, specifications, and reports. Manage non-conformances, CAPAs, and change management activities related to design quality. Provide guidance on regulatory requirements and standards related to orthopedic implant design. Participate in internal and external audits, including regulatory inspections.

Join our Sustaining Project Team as a Design Quality Engineer. Handle DHF, risk management, V&V, doc control, and ensure compliance with quality systems & regulatory standards. Experience with PLCP, FMEA, and CAPA is preferred. Required Candidate profile This role is strictly focused on Design Quality Engineering. It does not include Regulatory Affairs or Post-Market Surveillance (PMS) responsibilities.

Educational Bachelor of Engineering,BTech,Master Of Engineering,MTech Service Line Engineering Services Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide your teams towards developing optimized high quality code deliverables, continual knowledge management and adherence to the organizational guidelines and processes. You would be a key contributor to building efficient programs/ systems and if you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you!If you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you! Technical and Professional : Primary Skills: CTQ, QMS, ISO 13485, Design Documentation, CAPA, DHF Preferred Skills: Technology-CAD-CAD - Others

Educational Requirements Master Of Engineering,Master Of Technology,Bachelor Of Engineering,Bachelor Of Technology Service Line Engineering Services Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide your teams towards developing optimized high quality code deliverables, continual knowledge management and adherence to the organizational guidelines and processes. You would be a key contributor to building efficient programs/ systems and if you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you!If you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you! Technical and Professional Requirements: Primary Skills: CTQ, QMS, ISO 13485, Design Documentation, CAPA, DHF Preferred Skills: Technology->CAD->CAD - Others

Role & responsibilities: Product development experience in range of 4-7 years Experience with Medical device preferred. Experience with design change management and DHF deliverables. Good at communication Basic understanding of PLM/Windchill Technical report writing and communication with stakeholders. Skill Set: Must have - Product development experience Strong DHF Process Knowledege & working experience, ECN / ECR activities Techanical Report writing Medical Regulatory Medical domain Quality process Key Words & Tools: Medical Device design and development , Medical Domain Process, DHF , Risk Management , PLM activities Solidwork , PLM Windchill,

Verification and Validation R&D Primary responsibilities: Represent the Design Quality function on device development project teams and cross functional co-ordination with multiple departments including R&D, Quality Control, Manufacturing and Regulatory Affairs. Ensure that device development projects and changes to existing devices are conducted in compliance with the FDA 21CFR Part 820 Quality System Regulation, ISO 13485 Regulations, and other applicable standards like ISO 14971. Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting devices can be adequately manufactured and verified. Lead or support design activities including design verification, validation, test procedure development, usability engineering, and risk management. Generate or apply statistical methods with appropriate risk-based justification. Hands-on experience in Design History File compilation / Technical file documentation. Support internal and external inspections/ regulatory audits. Promote continuous improvement in design control activities and use of quality tools with design team. In-depth knowledge and understanding of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, 21 CFR 4 Regulation of Combination Products, 14971 Risk Management Standard, MDD, MDR, IEC/EN 62366 Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices Secondary responsibilities (Wherever applicable): Experience interacting with regulatory agencies and notified bodies Experience with process improvements, process qualification and validation. Experience in complaint investigation, corrective action and preventive action system, statistical methods, quality risk management and Post Market Surveillance.

Key Responsibilities: Create and update 2D and 3D CAD models and engineering drawings using SolidWorks. Maintain accurate CAD databases and revision-controlled design files in accordance with Quality Management System (QMS) protocols. Generate and maintain Bill of Materials (BOMs) for all products and design configurations. Support the Design History File (DHF) compilation by providing up-to-date drawings, BOMs, and release records. Ensure proper version control, file storage, and change documentation in alignment with document control procedures. Process Engineering Change Requests (ECRs) and execute Engineering Change Orders (ECOs) with appropriate drawing updates. Participate in design reviews, perform CAD documentation updates, and review drawing checklists for accuracy and completeness. Maintain traceability of design records across design input, output, verification, and validation stages. Collaborate with Quality Assurance (QA) to ensure all CAD deliverables meet internal standards and regulatory requirements (ISO 13485, FDA 21 CFR Part 820). Provide necessary design documentation and CAD records during internal and external audits. Support prototype and production teams by delivering precise and manufacturable CAD files and drawings. Communicate cross-functionally with R&D, QA, Manufacturing, and Regulatory teams. Required Qualifications: Diploma/Degree in Mechanical Engineering, Biomedical Engineering, or related field. 3+ years of experience in a CAD engineering role within a medical device or precision engineering company; orthopedic implant experience preferred. Expertise in SolidWorks and AutoCAD (3D modeling, assemblies, drafting, GD&T, drawing templates, etc.). Strong knowledge of engineering drawing standards (ASME Y14.5, ISO) and tolerancing practices. Familiarity with PLM/PDM systems and CAD data management tools. Understanding of Design Control principles, DHF documentation, and regulatory requirements for Class II/III medical devices. Hands-on experience with ECR/ECO processes and BOM management. Knowledge of manufacturing processes, particularly CNC machining, casting, and surface treatments relevant to orthopedic implants. Proficient in drawing review, revision tracking, and model history documentation. Detail-oriented, with strong analytical and organizational skills. Ability to work both independently and in a team-oriented environment. Nice to have hands on: Experience with Additive Manufacturing and FEA simulations is a plus. Familiarity with ISO 13485, FDA Design Control regulations, and CE/USFDA design documentation standards. Experience supporting audit processes (Notified Body, FDA, Internal) from a CAD/documentation perspective. Key Tools & Documents: SolidWorks, AutoCAD (2D/3D Modeling) Drawing Review Checklists Engineering Change Requests (ECRs) & Engineering Change Orders (ECOs) Bill of Materials (BOMs) DHF Drawing Contribution Records CAD Model Revision Logs Verification and Validation Evidence Document Control Systems (PDM/PLM)

Evaluate and improve Design History Files (DHFs) to ensure compliance with regulatory requirements, identifying gaps and implementing corrective actions. Conduct detailed audits and assessments of existing DHFs to identify non-conformances and areas for improvement, ensuring alignment with current regulations and standards, such as FDA and ISO 13485. Ensure completeness, accuracy, and accessibility of all DHF documentation, including design controls, specifications, verification and validation reports, and risk management files. Collaborate with R&D, Quality Assurance, Regulatory Affairs, and other relevant teams to gather necessary information for DHF updates and improvements, facilitating effective communication among stakeholders. Stay updated on current regulatory requirements and industry best practices related to medical device documentation and design controls, providing training and guidance to team members on DHF requirements and remediation processes. Support risk management processes by integrating relevant risk analysis and mitigation strategies into DHF documentation, collaborating on development and updates to the product Risk Management File. Utilize analytical skills to identify root causes of DHF issues and implement robust solutions, developing creative strategies to address complex documentation challenges. Lead DHF remediation projects, ensuring timely completion of tasks and adherence to project timelines, and reporting project status, challenges, and achievements to management and stakeholders. Conduct thorough reviews and validation of DHF and associated documentation to ensure compliance with quality standards, supporting audits and inspections by regulatory bodies with organized and accurate DHF documentation. 2-6 years of experience in DHF preparation or remediation in the medical device industry, and demonstrate strong understanding of regulatory standards and requirements, excellent organizational, project management, and communication skills.

Packaging Validation Engineer: Lead and execute packaging validation activities with a primary focus on seal integrity testing for sterile barrier systems. Develop and implement packaging test protocols and reports in alignment with ISTA (International Safe Transit Association) and ASTM standards. Design and perform package performance and distribution testing, including drop, vibration, and compression tests. Collaborate with R&D, Quality, Regulatory, and Manufacturing to ensure robust package designs and validation strategies. Drive root cause analysis and CAPA related to packaging failures. Maintain compliance with applicable regulatory standards including ISO 11607, FDA 21 CFR 820, and related guidelines. Manage packaging documentation including DHF, DMR, and validation records. Support continuous improvement initiatives in packaging processes and materials. Interface with external testing labs and suppliers to coordinate validation activities.

Packaging Validation Engineer: Lead and execute packaging validation activities with a primary focus on seal integrity testing for sterile barrier systems. Develop and implement packaging test protocols and reports in alignment with ISTA (International Safe Transit Association) and ASTM standards. Design and perform package performance and distribution testing, including drop, vibration, and compression tests. Collaborate with R&D, Quality, Regulatory, and Manufacturing to ensure robust package designs and validation strategies. Drive root cause analysis and CAPA related to packaging failures. Maintain compliance with applicable regulatory standards including ISO 11607, FDA 21 CFR 820, and related guidelines. Manage packaging documentation including DHF, DMR, and validation records. Support continuous improvement initiatives in packaging processes and materials. Interface with external testing labs and suppliers to coordinate validation activities.