Senior Product Management Engineer (Medical Devices)

Location: Plymouth, Minnesota, United States of America; hybrid schedule with 2 remote days and 3 onsite days. Up to 10% domestic and international travel may be required.

Salary: $94,000–$151,800 per year, plus eligibility for the long-term incentive program.

Company

Healthcare innovation organization developing and reprocessing single-use medical devices to reduce medical waste, lower health-system expenses, and meet or exceed original equipment manufacturer requirements.

What you will do

• Lead a cross-functional project team through new product development, production readiness, and launch.
• Plan validation strategies and own the Master Validation Plan for new product introductions.
• Partner with R&D, Quality, Technical Lifecycle Management, and external manufacturers to develop manufacturable processes and equipment.
• Develop project scopes, budgets, schedules, engineering specifications, and manufacturing equipment documentation.
• Qualify and validate equipment, develop and validate reprocessing test methods, and support safety and environmental initiatives.
• Perform root cause analysis and continuous improvement while authoring, revising, and training teams on technical documentation and production work instructions.

Requirements

• Bachelor’s or master’s degree in biomedical, mechanical, or electrical engineering, or an equivalent discipline.
• 4–6 years of progressively responsible product or process engineering experience in the medical device industry.
• Experience with DOE, FMEA, GMP, QSR, ISO-structured quality systems, design verification and validation, FDA submissions, and design transfer into manufacturing.
• Proficiency in Microsoft Office and Microsoft Project, with strong planning, multitasking, project management, written, and oral communication skills.
• Ability to work independently and collaboratively in a regulated manufacturing environment.

Nice to have

• Knowledge of SolidWorks.
• Experience with CAPA, process control, lean supply chain management, product costing, and validation testing.

Culture & Benefits

• Inclusive work environment focused on diversity, dignity, and individual contribution.
• 120 hours of vacation, 40 hours of sick time, and 13 paid holidays per calendar year.
• Parental, bereavement, caregiver, volunteer, military spouse, and personal or family leave benefits.
• Hybrid work arrangement combining remote work with regular onsite collaboration.