Medical Device 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, 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.