Are you an innovative engineer eager to take on new challenges? We are looking for a talented Staff Engineer to join our Product Transfer team in a greenfield project, helping to establish a new manufacturing site.

As a Staff Engineer, you will independently tackle a variety of technical problems, employing the latest engineering techniques to expedite product time to market while ensuring compliance with regulatory requirements, project deadlines, and cost constraints. You will build productive relationships both internally and externally and may periodically provide guidance and training to other team members.

Key Areas of Responsibility:

• Product and Process Support: Provide engineering support for new products, product transfers, and process introductions, ensuring all activities are documented per Stryker's new product development procedures.

• Quality Assurance: Ensure the quality of processes and products as defined by operational and material specifications.

• Component Selection: Select components and equipment based on specifications, reliability, and regulatory requirements. Collaborate with quality engineers to develop component-specific testing and inspection protocols.

• Capital Acquisition: Lead or support capital acquisition activities from equipment specification to validation.

• Data Analysis: Analyze equipment to establish operating data, conduct experimental tests, and analyze results. Lead or participate in process review meetings.

• Process Qualification: Participate in PFMEA, Control Plan, SOP, and PPAP activities related to product transfers and launches.

• Inspection Documentation: Complete capability studies for in-process inspection and generate subsequent inspection documentation.

• Measurement Systems Analysis: Conduct MSA studies for new products and processes.

• Training: Provide training to manufacturing team members.

• Compliance: Ensure adherence to GMP and safety procedures.

• Validation Documentation: Review and approve validation documentation.

• Additional Duties: Perform all other duties as assigned.

Qualifications and Skills:

• Education: B.S. in Mechanical Engineering or a related engineering discipline.

• Design for Manufacturing (DFM): Good understanding of DFM, related statistical tools, and validation/verification techniques.

• Technical Proficiency: Experience with MES/SAP, GD&T, process mapping, statistical methods, and process/product validations is beneficial.

• Manufacturing Knowledge: Good knowledge of manufacturing processes, materials, product, and process design.

• Technical Reading: Ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing.

• Validation Certification: Certified in validation activities.

• Regulatory Experience: Experience in an FDA-regulated or similarly regulated industry is beneficial.

• Teamwork: Proven track record of working in a team-based environment.

• Interpersonal Skills: Excellent interpersonal skills, able to express ideas and collaborate effectively with multidisciplinary teams. Open-minded with the ability to recognize valuable ideas.

• Innovation: Innovative thinker with the ability to envision new and improved methods.

• Problem-Solving: Experience with complex problem-solving techniques related to manufacturing and design technical issues. Strong instincts and sound judgment for mechanical and structural design..

Why Join Us?

This is your chance to be a key player in an exciting new manufacturing site. If you are an innovative engineer with a passion for excellence and a drive to succeed, apply now and help us shape the future!