Your Job Phillips Medisize, a Molex company is seeking a Product Development Lead for Medical and Drug Delivery Devices to join our team at our Hudson, WI site. In this role, you will spearhead the design, development and launch for cutting-edge medical device and drug delivery solutions. This role offers the opportunity to guide technical direction, oversee system architecture and ensure compliance with industry standards, while working closely with customers and cross-functional teams.
What You Will Do- 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.
- Communicate project status and challenges to internal and external stakeholders.
- 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.
Who You Are (Basic Qualifications)- Bachelor's Degree or higher in Biomedical, Electrical, Mechanical, or Biological Engineering
- 5+ 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, diverse quality management systems.
What Will Put You Ahead- Experience in Drug Delivery, MedTech or Diagnostics.
- Strong leadership experience facilitating risk-based decision-making.
- Excellent project management, communication, and problem-solving skills across complex team and project structures.
This position does not qualify for VISA Sponsorship.
Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.
Our Benefits Our goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength - focusing on overall wellbeing so you can focus on what matters most. Our benefits plan includes - medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement, paid vacation/time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Specific eligibility criteria is set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions on what benefits apply to you, please speak to your recruiter.
Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.
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