Senior Medical Device Product & Drug Delivery Lead

Phillips Medisize; Hudson (WI); On-site; USD 120,000 - 180,000; Full time

Job summary

Phillips Medisize in Hudson, WI is seeking a Product Development Lead for medical devices and drug delivery systems to drive design, development and launch from concept through launch. You will guide technical direction, oversee system architecture, and ensure compliance with FDA, ISO 13485, IEC 60601 and related standards while collaborating with customers and cross-functional teams.

You will mentor engineers, manage risk, drive documentation (DHF/DMR), and lead validation activities.

Qualifications

• 5+ years in medical device design/development with 3+ years in leadership.
• Experience with FDA Class II/III devices, design controls, ISO 14971 risk management, and validation.
• Familiarity with FDA 21 CFR Part 820, ISO 13485, IEC 62304, IEC 60601.
• Experience supporting regulatory submission documentation.
• Experience with multiple quality management systems.

Responsibilities

• Lead technical direction and execution of medical device and drug delivery projects from concept through launch.
• Collaborate with customers and cross-functional teams to ensure development and compliance with FDA/ISO standards.
• Oversee system architecture, design specs, risk management, and verification/validation plans; mentor engineering teams.
• Drive technical decisions, risk mitigation, and documentation (DHF, DMR, technical files); lead RCA and CAPA support.
• Stay current on emerging technologies and regulatory changes; communicate status to stakeholders.
• Guide system-level integration across mechanics, electronics/software, molding/assembly, usability; define development strategy with traceability.

Skills

Medical device design

Technical leadership

FDA regulations

Risk management

Design controls

Validation

Quality systems

Education

Biomedical/Electrical/Mechanical Engineering degree

Job description

Phillips Medisize in Hudson, WI is seeking a Product Development Lead for medical devices and drug delivery systems to drive design, development and launch from concept through launch. You will guide technical direction, oversee system architecture, and ensure compliance with FDA, ISO 13485, IEC 60601 and related standards while collaborating with customers and cross-functional teams.

You will mentor engineers, manage risk, drive documentation (DHF/DMR), and lead validation activities.