Position Summary
Independently determines and develops approaches to a variety of technical problems of moderate scope and complexity.
Key Responsibilities
* Provides 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.
* Ensures quality of process and product as defined in the appropriate operation and material specifications.
* Selects components and equipment based on analysis of specifications, reliability and regulatory requirements.
* Works with quality engineers to develop component specific testing and inspection protocols.
* May lead/support capital acquisition activity from specifying equipment, contract negotiation, installation and validation.
* Analyses equipment to establish operating data, conducts experimental tests and results analysis.
* Leads and/or participates in process review meetings.
* Participates in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.
* Completes capability studies for in-process inspection and generates subsequent inspection documentation.
* Conducts MSA studies for new products and new processes.
* Provides training for manufacturing team members.
* Ensures adherence to GMP and safety procedures.
* Reviews and approves validation documentation.
* Performs all other duties as assigned.
Requirements
* Bachelor's degree in Mechanical Engineering or related engineering discipline with 2 or more years' experience or a related master's degree.
* Proven track record of working in a team-based environment.
* Excellent interpersonal skills - able to express ideas and collaborate effectively with multidisciplinary teams.
* Open-minded with the ability to recognize good ideas.
* Innovative thinker - able to envision new and better ways of doing things.
* Experience in executing complex problem-solving techniques related to manufacturing/design technical issues.
* Good instincts and sound judgment for mechanical and structural design.
* Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques.
* Excellent analytical skills, ability to plan, organize and implement concurrent tasks.
* Good knowledge of manufacturing processes, materials, product and process design.
* Able to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing.
* Certified in validation activities.
* Experience in an FDA-regulated or regulated industry is beneficial.