Phillips Medisize, a Molex company is seeking a Product Development Lead for Medical and Drug Delivery Devices to spearhead the design, development and launch or cutting-edge medical device and drug delivery solutions.
Requirements
- 7+ years' experience in medical device design/development, with 3+ years in technical leadership.
- Experience with FDA Class II/III devices, design controls, risk management (ISO 14971), and validation.
- Familiarity with FDA 21 CFR Part 820, ISO 13485, IEC 62304, IEC 60601
- Experience supporting development of regulatory submission documentation packages.
- Experience working with multiple quality management systems.
- Experience leading development of Drug Delivery Devices, Wearables or Catheters.
- Strong leadership experience facilitating risk-based decision-making.
Responsibilities
- Lead the technical direction and execution of medical device and drug delivery projects from concept through launch.
- Collaborate with customers and cross-functional teams (R&D, Quality, Regulatory, Manufacturing,) to ensure seamless product development and compliance with FDA, ISO 13485, IEC 60601, and related standards.
- Oversee system architecture, design specifications, risk management, and verification/validation plans, while managing and mentoring engineering teams to foster innovation and technical excellence.
- Drive technical decision-making, risk mitigation, and documentation (DHF, DMR, technical files).
- Lead root cause analysis and support CAPA for device issues.
- Stay current on emerging technologies and regulatory changes.
- Guide system-level integration across technical domains (mechanics, electronics/software, molding/assembly, usability, etc.), and define development strategy with strong engineering and data traceability, especially in customer-driven programs.
Other
- Bachelor's Degree or higher in Biomedical, Electrical, Mechanical, or Biological Engineering
- Communicate project status and challenges to internal and external stakeholders.
- Excellent project management, communication, and problem-solving skills across complex team and project structures.
- This position does not qualify for VISA Sponsorship.
- Except where prohibited by state law, some offers of employment are conditioned upon successfully passing a drug test.
