Sr. Manufacturing Process Engineer

Position Description 

This role executes the innovation and development of assigned project elements with an emphasis on the manufacturing process, technology and procedures required for the manufacturing of Medical Device products. 

 Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.
 
 KEY AREAS OF RESPONSIBILITY

• Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures.
• Ensure quality of process and product as defined in the appropriate operation and material specifications.
• Will assist in the selection of components and equipment based on analysis of specifications, reliability, and regulatory requirements. Work with quality engineers to develop component-specific testing and inspection protocols.
• Support capital acquisition activity from specifying equipment, contract negotiation, installation, and validation.
• Will analyze equipment to establish operating data, conduct experimental tests, and perform result analysis. Lead and/or participate in process review meetings.
• Participate in PFMEA, Control Plan, SOP, and PPAP generation associated with product transfers and launches.
• Complete capability studies for in-process inspection and generate subsequent Inspection documentation.
• Conduct MSA studies for new products and new processes.
• Provide training for manufacturing team members.
• Ensure adherence to GMP and safety procedures.
• Review and approval of validation documentation.

• High School diploma or equivalent.
• Requires 2 years of relevant experience.
• Must possess excellent organization and communication skills.
• Must be PC literate, proficiency with Microsoft Office applications
• Preferred Qualifications:
  • Technical Associates Degree preferred.
  • Demonstrated ability to read and interpret complex drawings and have the ability to understand geometrical dimensioning and tolerancing (incl. GD&T)
  • High knowledge of manufacturing processes and materials
  • Demonstrated ability to lay out and set-up machines as well as lead or conduct manufacturing batch runs.
  • Demonstrated ability to inspect product with the use of all standard inspection tools.
  • Demonstrated communication and interpersonal skills, with the ability to work successfully in a team-based environment that heavily emphasizes quality, performance, and accountability.
  • Problem solving skills and ability to handle tasks in a fast-paced environment.