Job Title: Process Development Engineer (Staff)
Independently determines and develops approaches to a variety of technical problems of moderate scope and complexity.
Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.
Builds productive internal and external working relationships and may periodically provide guidance and train other team members.
Key Areas of Responsibility
1. 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.
2. Ensure quality of process and product as defined in the appropriate operation and material specifications.
3. Select components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
4. Lead/support capital acquisition activity from specifying equipment, contract negotiation, installation and validation.
5. Analyse equipment to establish operating data, conduct experimental tests and result analysis. Lead and/or participate in process review meetings.
6. Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.
7. Complete capability studies for in process inspection and generate subsequent inspection documentation.
8. Conduct MSA studies for new products and new processes.
9. Provide training for manufacturing team members.
10. Ensure adherence to GMP and safety procedures.
11. Review and approve validation documentation.
12. All other duties as assigned.
Required Skills
1. Bachelor's degree in Mechanical Engineering or related engineering discipline with 4 or more years' experience.
Preferred Skills
1. Proven track record of working in a team-based environment.
2. Excellent interpersonal skills - able to express ideas and collaborate effectively with multidisciplinary teams. Be open-minded with the ability to recognise good ideas.
3. Innovative thinker - should be able to envision new and better ways of doing things.
4. Experience in executing complex problem-solving techniques related to manufacturing/design technical issues. Good instincts and sound judgment for mechanical and structural design.
5. Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques.
6. Analytical skills, ability to plan, organise and implement concurrent tasks.
7. Good knowledge of manufacturing processes, materials, product and process design.
8. Ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing.
9. Experience in validation activities.
About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.