Biocon - Senior/Design Quality Engineer - Medical Devices Design Verification/Validation

Sr. ENGINEER - Medical Devices DESIGN Verification & Validation (V&V)/ DESIGN QUALITY ENGINEER (DQE)

- 10+ years Experience in development and testing of combination products, class II & III medical devices

- Developed Design Inputs and managed design verification & process validation for devices

- Manage and develop CFT co-ordination with diverse quality, RA, Mfg. teams

- Conversant with Risk Management, Hazard Analysis, FMEAs (user/ design/ process), RCA for devices

- Manage 483 response and CAPA following FDA inspection. Lead CAPA investigations, RCA and documentation

- Defined design verification strategy and acceptance criteria for injection/ drug delivery system in order to appropriately risk and compliance

- Built prototypes and developed intellectual property for devices

- Strong Technical problem solving skills; Broad technical acumen in complex devices and drug delivery systems

- Design control and quality requirements SOP experience

- Experience in navigating complex Product development processes with experience of FDA/ regulatory requirements 510k, PMA, CAPA, IEC 60601, ISO 14971, ISO 13485, ISO 11608

- Exposure to FDA QSR Part 4, Part 820 with respect Drug delivery systems and combination devices

- Experience with Single use, disposable as well as re-usable device systems.

- Development of design verification protocols and methods, Test Method development, Device Analytics

- Strong statistical skill set including Measurement Systems Analysis, acceptance sampling plans, and capability analysis

- Proficient with CAD, CAM, CAE and Minitab.

- Use of LIMS, Testing setups like Instron and other lab systems.

- Experience with process improvements, process planning and management.

- Experience with Electromechanical systems and S/W interfaces will be added advantage

- RAPS certification, ISO 13485 auditor certification desired