Device Development Engineer
2 days ago
At Biocon Biologics, we are pioneers in the biosimilars revolution, shaping a future where healthcare is accessible to all. Our mission is to impact a billion lives by fostering innovation, patient-centricity, and disruptive thinking.
We are a multicultural global company with a long-term commitment to delivering high-quality affordable biosimilars worldwide.
About the RoleThis role requires an experienced Device Development Engineer - Quality Assurance professional to represent our Design Quality function on device development project teams and facilitate cross-functional coordination with multiple departments, including R&D, Quality Control, Manufacturing, and Regulatory Affairs.
The ideal candidate will ensure that device development projects and changes to existing devices comply with FDA 21CFR Part 820 Quality System Regulation, ISO 13485 Regulations, and other applicable standards like ISO 14971.
You will provide input to design and manufacturing documentation, including material specifications, drawings, inspection procedures, and manufacturing procedures, to guarantee that resulting devices can be adequately manufactured and verified.
This role also involves leading or supporting design activities, including design verification, validation, test procedure development, usability engineering, and risk management.
Responsibilities include setting up testing infrastructure, test benches, jigs, and fixtures for mechanical and electro-mechanical drug delivery system testing.
You will plan and execute verification of prototypes, pilot batches, feasibility runs for drug delivery systems.
This role also requires hands-on experience in Design History File compilation/Technical file documentation.
Additionally, you will support internal and external inspections/regulatory audits and promote continuous improvement in design control activities and use of quality tools with the design team.
You will have 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.
Requirements- 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
- Experience: 6 to 9 years
Estimated salary range: $120,000 - $180,000 per annum, depending on qualifications and location.
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