Senior Product Management Engineer — Hybrid MedTech

Antler; Plymouth (MN); Hybrid; USD 94,000 - 152,000; Full time

Benefits offered by this job

Vacation – 120 hours per year

Sick time – 40 hours per year (vary by

Holiday pay – 13 days per year

Parental Leave – 480 hours

Volunteer Leave – 32 hours

Military Spouse Time-Off – 80 hours

Job summary

Johnson & Johnson Sustainability Solution (Sterilmed) is seeking a Senior Product Management Engineer for our Plymouth, Minnesota location. You will lead a cross-functional team to transfer reprocessed medical devices into production, oversee validation plans for new products, and drive process improvements in collaboration with R&D, QA, and external manufacturers.

The role emphasizes ISO quality systems, documentation, and competencies in design transfer, FDA considerations, and manufacturing

Qualifications

• BS or MS in Biomedical, Mechanical, or Electrical Engineering or equivalent.
• 4–6 years of product/process engineering experience in medical devices.
• Experience with DOE, FMEA, GMP, and QSR.
• SolidWorks knowledge preferred; strong MS Office and MS Project skills.
• Ability to work within an ISO quality system; strong planning and communication.

Responsibilities

• Lead a multifunctional team to drive new product development from readiness to launch.
• Plan validation strategies and own Master Validation Plan for NPI.
• Identify and implement technologies to improve quality, cost, safety and compliance.
• Ensure timely pilots aligned with new product production activities.
• Collaborate with R&D to develop manufacturable processes for new products.
• Define project scopes, budgets, schedules and specs for equipment.
• Ensure equipment is qualified/validated and supports safety and environmental goals.
• Develop and validate reprocessing test methods.
• Review and edit engineering docs: reports, work instructions, validation.
• Familiar with medical device development: design, verification/validation, FDA submissions.
• Prepare and update production work instructions; train staff.
• Escalate business issues/opportunities to management.

Skills

DOE

FMEA

GMP & QSR

Medical device experience

ISO quality system

Project management

Communication skills

Team collaboration

Education

BS/MS in Biomedical/Mechanical/Electrical Engineering

Tools

SolidWorks

MS Office

MS Project

Job description

Johnson & Johnson Sustainability Solution (Sterilmed) is seeking a Senior Product Management Engineer for our Plymouth, Minnesota location. You will lead a cross-functional team to transfer reprocessed medical devices into production, oversee validation plans for new products, and drive process improvements in collaboration with R&D, QA, and external manufacturers.

The role emphasizes ISO quality systems, documentation, and competencies in design transfer, FDA considerations, and manufacturing