Role & responsibilities Build the QMS end to end to ISO 13485:2016 : perform gap analysis, draft SOPs/WIs, deploy training, run Stage 1/2 audits and close nonconformities to achieve certification. Own Design Controls & Documentation: create/maintain SRS, DHF, DMR, Risk Management File (ISO 14971) , software lifecycle records (IEC 62304), trace matrices and labelling; ensure change control discipline. Regulatory Strategy & Submissions: chart and execute stepwise pathways CDSCO manufacturing licence & device registration first, then FDA 510(k) and EU MDR CE Mark ; prepare technical documentation/dossiers and coordinate with test labs, auditors and notified bodies. Audits, CAPA & Metrics: plan and conduct internal audits, lead CAPA investigations, track effectiveness, and publish quality KPIs (training status, NC/CAPA ageing, doc control health) to leadership. Supplier & Manufacturing Quality: qualify critical suppliers/CMOs; define IQ/OQ/PQ plans; establish incoming /in-process controls, traceability and batch-release evidence. Consumables & Sterilisation Readiness: support packaging validation and sterile barrier qualification (ISO 11607) and sterilisation modality alignment (EtO/Gamma) as relevant. Post Market & Vigilance: set up complaint handling, PMS/vigilance procedures and field action workflows aligned with India/US/EU expectations. Enable & Train Teams: interpret standards for engineers, run checklists and docs clinics, and raise the organisation's documentation quality. eQMS / Doc Control: implement pragmatic doc and record control and training record systems with audit trails. Preferred candidate profile Bachelor's degree in Engineering/Life Sciences (Biomedical/Mechanical/Electronics or related). ISO 13485 internal auditor certification preferred (or willingness to obtain within 6 months). 4+ years of QARA experience on Class II+ medical devices, with hands-on ISO 13485 implementation and participation in at least one CDSCO dossier or a 510(k)/EU MDR Technical File. Working knowledge of ISO 14971, IEC 62304, IEC 60601 (awareness), IEC 623661 (usability), ISO 10993, ISO 11607, and Indian MDR 2017; familiarity with UDI concepts and eQMS workflows (doc control, training, CAPA). Excellent technical writing and the ability to translate regulatory language into clear, actionable guidance for engineers. Track record of operating with minimal supervision across multiple concurrent workstreams.
Role & responsibilities Lead schematic, PCB layout reviews and BOM ownership for low-power, battery-operated Class II devices using STM32 MCUs, sensors and actuator drivers; drive DfX (DfM/DfT/DfA). Design robust power architecture (Lithium-ion battery, charging, fuel gauge, buck/boost rails) and implement protections, measurement and low power strategies. Own board bring-up, functional test jigs and production test plans; collaborate with Firmware on diagnostics and calibration. Engineer for EMC/EMI and safety from day one: return path control, filtering, shielding, creepage/clearance; plan pre-compliance for IEC 606011/12 and CISPR 11; address ESD/transients. Implement safety/diagnostic circuitry (e.g., watchdog, current/thermal limits, sensor redundancy/fault detection) aligned with risk controls (ISO 14971). Manage fab/assembly vendors: Gerbers, fabrication notes, stackup, panelisation, DFM feedback, FAI/PPAP-like qualification, ECOs and component LTB/alternate planning. Maintain complete design control documentation (schematics, layouts, calculations, verification reports) and support regulatory/lab testing. Work with Mechanical on packaging, connectors, flex assemblies and thermal considerations. Preferred candidate profile Bachelor's/Master's in Electrical/Electronics Engineering or related field. 3+ years of experience designing mixed signal embedded hardware; proficiency with KiCad or Altium, and SPICE level simulation. Strong fundamentals in analogue/frontend design, sensor interfacing, motor/actuator drivers and power electronics for wearables. Hands-on skill with oscilloscopes, analysers and bench debug; ability to read and critique layouts for EMC/DFM. Working knowledge of ISO 13485 (design controls), IEC 606011/12, ISO 14971; familiarity with IEC 62304 interfaces and IEC 623661 is a plus; awareness of IEC 62133 for rechargeable cells. Startup Environment and Mindset: Operate like an owner in a startup: high autonomy, proactive problem solving, minimal supervision, and a willingness to wear multiple hats beyond your primary role (including documentation, supplier calls and quick lab work). Bias for clear written communication and early escalation of blockers. There is limited handholdingexpect to define, implement and continuously improve processes.
Role & responsibilities Design and develop medical device mechanical components and assemblies from concept to production Take full ownership of assigned projects, ensuring on-time completion with minimal supervision Create detailed 3D CAD models, engineering drawings, and specifications with appropriate GD&T Select appropriate materials, components, and manufacturing processes for medical devices Perform engineering analyses including tolerance stack-ups, stress analysis, and failure mode investigations Collaborate with cross-functional teams including electronics, firmware, and regulatory affairs Design for manufacturability, reliability, and cost-effectiveness Develop and execute verification and validation testing protocols Participate in risk management activities including FMEA and hazard analyses Identify and qualify vendors for components and manufacturing processes Prepare technical documentation for regulatory submissions (Indian and future FDA) Continuously improve existing designs based on feedback and performance data Preferred candidate profile Bachelor's or Master's degree in Mechanical Engineering or related field 3+ years of experience in mechanical design for medical devices or similar regulated products Proficiency in 3D CAD software (preferably SolidWorks) Strong knowledge of manufacturing processes, material selection, and DFM principles Experience with GD&T and engineering tolerancing Familiarity with medical device standards and regulations (ISO 13485, IEC 60601, FDA QSR) Understanding of sterilization methods and biocompatibility considerations for medical devices Experience with prototype development, testing, and validation Knowledge of risk management processes (ISO 14971) and quality management systems Strong problem-solving abilities and attention to detail Self-motivated with exceptional initiative and ability to work with minimal supervision Excellent communication skills and ability to work in a collaborative environment Experience bringing a medical device from concept to production is highly desirable Startup Environment and Mindset: Operate like an owner in a startup: high autonomy, proactive problemsolving, minimal supervision, and a willingness to wear multiple hats beyond your primary role (including documentation, supplier calls and quick lab work). Bias for clear written communication and early escalation of blockers. There is limited handholdingexpect to define, implement and continuously improve processes.
Role & responsibilities Lead end-to-end design and industrialisation of disposable drug reservoirs, infusion sets and fluidpath components for wearable delivery devices. Create concept and detailed CAD, drawings and tolerance stacks optimised for highvolume injection moulding and automated assembly; drive DfM/DfA with suppliers. Prototype rapidly and validate to requirements (leak/occlusion/burst, flow resistance, particulate, usability) with documented V&V. Select materials and joining methods (medicalgrade polymers, adhesives, cannulas, membranes) aligned with ISO 10993, ISO 80369 and ISO 11607; consider sterilisation (EtO/gamma) and package validation. Own DHF artefacts and risk analysis (ISO 14971); support process validation (IQ/OQ/PQ), FAI/PPAP and production ramp. Identify and onboard manufacturers; qualify moulds/tooling, agree process windows and inspection plans; monitor cost, yield and reliability. Feed postmarket learnings into design updates to improve robustness and cost. Preferred candidate profile Bachelor's/Masters in Mechanical Engineering, Polymer Science or related field. 4+ years of experience with Mandatory prior experience in delivering medical consumables (reservoirs/tubing/catheters or analogous devices) from concept to mass production. Proficiency in SolidWorks (required), GD&T, tolerance analysis; exposure to Moldflow/CAE is a plus. Strong grasp of fluid handling, sealing and failure mode prevention for small volume drug delivery; familiarity with sterilisation and shelf-life considerations. Working knowledge of ISO 13485, ISO 80369, ISO 10993, ISO 11607 and ISO 8536 where applicable. Clear, complete documentation and effective supplier collaboration. Startup Environment and Mindset: Operate like an owner in a startup: high autonomy, proactive problem solving, minimal supervision, and a willingness to wear multiple hats beyond your primary role (including documentation, supplier calls and quick lab work). Bias for clear written communication and early escalation of blockers. There is limited handholding—expect to define, implement and continuously improve processes.