Senior Medical Device Product Lead

Koch Business Solutions, LP; Hudson (WI); On-site; USD 120,000 - 170,000; Full time

Job summary

Phillips Medisize in Hudson, WI is seeking a Product Development Lead for Medical and Drug Delivery Devices. You will spearhead design, development and launch for cutting-edge medical device and drug delivery solutions, guiding technical direction and ensuring compliance while collaborating with customers and cross-functional teams.

The role requires leadership across system architecture, risk management, and verification/validation plans, mentoring engineers and driving data traceability in

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.

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.
• Oversee system architecture, design specifications, risk management, and verification/validation plans, while mentoring engineering teams.
• 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 and define development strategy with strong engineering and data traceability in customer-driven programs.

Skills

Biomedical Engineering

Electrical Engineering

Mechanical Engineering

Biological Engineering

Education

Bachelor's degree or higher in Biomedical, Electrical, Mechanical, or Biological Engineering

Job description

Phillips Medisize in Hudson, WI is seeking a Product Development Lead for Medical and Drug Delivery Devices. You will spearhead design, development and launch for cutting-edge medical device and drug delivery solutions, guiding technical direction and ensuring compliance while collaborating with customers and cross-functional teams.

The role requires leadership across system architecture, risk management, and verification/validation plans, mentoring engineers and driving data traceability in