Product Development Lead

KOCH INDUSTRIES INC • Hudson, WI • 4h ago

JOB REQUIREMENTS: Your Job 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 or 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
7+ 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 quality management systems.
What Will Put You Ahead Experience leading development of... For full
info follow application link. Equal Opportunity Employer, including
disability and protected veteran status. *** APPLICATION
INSTRUCTIONS: Apply Online: ipc.us/t/AA5889BF84D4409C

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