Product Development Lead

Flint Hills Resources; Hudson (WI); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Health savings account

Life insurance

Retirement plan

Education assistance

Parental leave

Paid time off

Job summary

Phillips Medisize, a Molex company, seeks a Product Development Lead for Medical and Drug Delivery Devices at our Hudson, WI site. You will spearhead design, development and launch of cutting-edge medical devices and drug delivery solutions.

Lead technical direction, oversee system architecture, ensure FDA/ISO compliance, work with customers and cross-functional teams, mentor engineers and drive risk management and verification/validation.

Qualifications

• Bachelor’s degree in Biomedical, Electrical, Mechanical, or Biological Engineering.
• 5+ years in medical device design/development with 3+ years of leadership.
• Experience with FDA Class II/III devices, design controls, ISO 14971.

Responsibilities

• Lead the technical direction from concept through launch for medical devices.
• Collaborate with R&D, Quality, Regulatory, and Manufacturing to ensure compliant development.
• Oversee system architecture, risk management, DHF/DMR documentation, and V&V plans.
• Mentor engineering teams and drive root-cause analysis and CAPA as needed.
• Stay current on regulatory changes and communicate status to stakeholders.
• Guide cross-domain integration and define development strategy with data traceability.

Skills

Medical device design

Technical leadership

FDA regulations

Design controls

Risk management

Regulatory submissions

Cross-functional collaboration

Education

Biomedical Engineering

Electrical Engineering

Mechanical Engineering

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.

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.

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.

Equal Opportunity Employer, including disability and protected veteran status. Except where prohibited by state law, some offers of employment are conditioned upon successfully passing a drug test. This employer uses E-Verify.