Description

Sterilmed, part of the Johnson & Johnson Medical Devices Companies , is now recruiting for a Staff Product Management Engineer located in Plymouth, Minnesota .

Remote Candidates will not be considered for this position.

Sterilmed , part of the Johnson & Johnson Medical Devices Companies, is a a world-class organization dedicated to improving our environment and growing cost savings for healthcare providers by offering reprocessed device solutions. In this exciting and critical role, you will lead and provide direction for new product introduction to develop and validate manufacturing processes for reprocessed medical devices. Deliver the technical requirements to ensure a robust and on time product transfer. Inspire and support the development and identification of creative solutions and problem solving to deliver solutions to the customer.

The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

Key Role & Responsibilities:

• Serve as the Project Lead of a multifunction team to drive new product development activities from new product into production through close cooperation with External Manufacturer, Jabil.
• Develop and confirm methods for reprocessing of assigned devices.
• Write equipment qualification and test method validation documentation and conduct required testing as needed.
• Design and build new components and assembly tooling.
• Perform testing and inspection functions including forensics and root cause analysis.
• Assist regulatory compliance efforts and verification and documentation related to engineering standards.
• Author, revise, train, and provide support for production work instructions for design transfer into manufacturing.
• Identify new processing needs.
• Role may include project and team management responsibilities.
• Committed to building a positive culture.
• Responsible for presenting business related issues or opportunities to next management level.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Qualifications

Education:

• Bachelor’s degree in biomedical, Manufacturing, Industrial, Mechanical or equivalent Engineering degree required.

Required Skills:

• Minimum of 6 to 8 years of work experience in Medical Devices
• Project Management 

Preferred Skills:

• Manufacturing Transfer for New Product Introduction strongly 
• Formal Certification in Project Management is preferred
• Experience with DOE, FMEA, GMP, GDP, and QSR preferred.
• Experience with 21 CFR part 820 and ISO 13485 requirements preferred.
• Proficient in Microsoft Office and Microsoft Project preferred.
• Strong technical writing skills preferred.
• Ability to work within an ISO structured quality system preferred.
• Good planning, multi-tasking, and project management skills preferred.
• Consistent record of completing projects on time and accomplishing goals preferred.
• Ability to function independently as well as within a team preferred.
• Excellent written and oral communication skills preferred.
• Ability to balance multiple priorities in fast-paced environment preferred.
• Formal Certification in Project Management is preferred.
• Project Management experience or certificate preferred.

Other:

• Travel for this position will average 10%

Johnson & Johnson provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.