Product Development Lead

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 Engineering5+ 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 60601Experience 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.At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. 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.Hiring Philosophy