Senior Product Manager, Medical Device Reprocessing Hybrid

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

Benefits offered by this job

Hybrid work schedule

Travel up to 10%

Job summary

Johnson & Johnson Sustainability Solution (Sterilmed) seeks a Senior Product Management Engineer for Plymouth, Minnesota. You will lead cross-functional teams to transfer reprocessed medical devices into production, partnering with R&D, Quality, and External Manufacturer to design repeatable processes and ensure high-quality manufacturing.

The role requires 4–6 years in the medical device industry, strong project management, and experience with DOE/FMEA/GMP/QSR; hybrid schedule (2 days

Qualifications

• BS or MS Degree in Biomedical, Mechanical, Electrical Engineering or equivalent.
• Minimum 4 to 6 years of increasingly responsible product/process engineering experience.
• Experience with DOE, FMEA, GMP, and QSR.
• Experience in the medical device industry.
• SolidWorks knowledge preferred.
• Proficient in Microsoft Office and Microsoft Project.
• Ability to work within an ISO structured quality system.
• Good planning, multi-tasking, and project management skills.
• Ability to function independently as well as part of a team.
• Excellent written and oral communication skills.

Responsibilities

• Serve as project manager of a multifunctional team to drive new product development activities from production readiness to launch.
• Plans validation strategies and owner of Master Validation Plan for New Product Introduction.
• Proposes and determines new or improved technologies to enhance product quality, manufacturing cost efficiencies, personnel safety and regulatory compliance.
• Oversees timely completion of pilot operations consistent with new product production activities of the department.
• Work closely with research and development team to develop processes that are manufacturable for new product.
• Develops project scopes, budgets and schedules for assigned projects and develops engineering specifications and documentation for manufacturing equipment.
• Ensures equipment is qualified/validated and supports safety and environmental initiatives.
• Develop and validate test methods for reprocessing of assigned devices.
• Reviews and edits all engineering documentation related to assigned projects, such as technical reports, work instructions and validation.
• Familiar with all aspects of medical device product development, including design, verification and validation, FDA submission, and design transfer into manufacturing.
• Author, revise, train, and provide support for production work instructions.
• Responsible for communicating business-related issues or opportunities to next management level

Skills

Project management

Communication skills

ISO quality systems

Medical device industry experience

DOE/FMEA/GMP/QSR experience

Independent working

Education

BS or MS Degree in Biomedical, Mechanical, Electrical Engineering or equivalent

Tools

SolidWorks

Microsoft Office

Microsoft Project

Job description

Johnson & Johnson Sustainability Solution (Sterilmed) seeks a Senior Product Management Engineer for Plymouth, Minnesota. You will lead cross-functional teams to transfer reprocessed medical devices into production, partnering with R&D, Quality, and External Manufacturer to design repeatable processes and ensure high-quality manufacturing.

The role requires 4–6 years in the medical device industry, strong project management, and experience with DOE/FMEA/GMP/QSR; hybrid schedule (2 days