Staff Engineer - Process Development, Advanced Operations
This role is responsible for independently determining and developing approaches to various technical problems of moderate scope and complexity. The ideal candidate will use the latest engineering techniques to reduce product time to market while adhering to regulatory requirements, project deadlines, and product costs.
Key Responsibilities:
* Provide engineering support for new product and process introductions, ensuring all activities are completed and documented in accordance with Stryker's new product development procedures.
* Ensure quality of process and product as defined in the appropriate operation and material specifications.
* 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.
* Lead/support capital acquisition activity from specifying equipment, contract negotiation, installation, and validation.
* Analyse equipment to establish operating data, conduct experimental tests, and 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.
Requirements:
* B.S in Mechanical Engineering or related engineering discipline with 4 or more years' experience or a related masters degree.
* Proven track record of working in a team-based environment.
* Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams.
* Be open-minded with the ability to recognize good ideas.
* Innovative thinker - should be able to envisage 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.
* Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
* Certified in validation activities.
* Experience in an FDA-regulated or regulated industry beneficial.
* High level of PC Skills required.
* Excellent attention to detail.