Product Development 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, 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.

Our Team

At Philips Medisize, we aspire to be the preferred partner of choice for leading global customers, to create innovative products that help people around the world live healthier, more productive lives. We are an end-to-end provider of innovation, development, and manufacturing solutions to the medical, regulated products, automotive, consumer and defense markets.Companies count on Phillips Medisize to bring their breakthrough ideas and innovative branded products to market – with confidence.As a contract design and manufacturing organization (CDMO), we work closely with our customers to deliver proven, highly engineered products.

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.

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

All Koch companies value diversity of thought, perspectives, aptitudes, experiences, and backgrounds. We are Military Ready and Second Chance employers. Learn more about our hiring philosophy here .

Who We Are

As a Molex company, Phillips-Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe.

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

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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