Job Requirements
Role Summary
Lead systems engineering activities for medical device product development and life cycle management programs, driving system architecture, requirements management, risk management, product integration, verification & validation, and regulatory compliance from concept through commercialization and post-market support.
Key Responsibilities
- Lead system definition, requirements engineering, architecture development, design integration, and verification & validation activities for medical devices.
- Translate user needs, clinical requirements, and business objectives into system requirements and technical specifications.
- Drive compliance with Design Controls, FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, and applicable regulatory standards.
- Lead system-level risk management activities including Hazard Analysis, FMEA, Fault Tree Analysis, and implementation of risk controls.
- Collaborate with cross-functional teams including Software, Hardware, Mechanical, Quality, Regulatory, Manufacturing, and Clinical teams throughout the product lifecycle.
- Support Life Cycle Management (LCM) activities including product enhancements, design changes, component obsolescence, supplier changes, cost reduction initiatives, complaint investigations, CAPA, and post-market support.
- Lead technical reviews, design reviews, problem-solving activities, root cause investigations, and system integration efforts.
- Mentor junior engineers and drive systems engineering best practices across development programs.
Qualifications
- Bachelor's or Master's degree in Systems Engineering, Biomedical, Electrical, Mechanical, Mechatronics, or related engineering discipline.
- 8-12+ years of experience in Systems Engineering with 3-5+ years in Medical Device Product Development and/or Life Cycle Engineering.
- Strong experience in requirements management, system architecture, product integration, risk management, verification & validation, and design controls.
- Hands-on knowledge of FDA, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, and EU MDR requirements.
- Experience with requirements management tools such as DOORS, Jama, Polarion, or equivalent.
- Excellent leadership, stakeholder management, analytical, problem-solving, and communication skills.
Preferred Qualifications
- Experience with connected medical devices, cybersecurity, software-enabled products, and cloud-connected healthcare solutions.
- Knowledge of Agile, Hybrid, and V-Model development methodologies.
- INCOSE Certification (ASEP/CSEP/ESEP) and PMP/CAPM certification are desirable.
- Experience in sustaining engineering, product remediation, manufacturing transfer, and regulatory compliance programs.
