Job Title: Process Development Engineer (Staff)
Reports to Associate Manager, this 23-month fixed-term contract is based in Carrigtwohill, Cork, Ireland.
Position Summary
Independently determines and develops approaches to technical problems of moderate scope and complexity.
Uses the latest engineering techniques to reduce product time to market while 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
* Provides engineering support for new product and process introductions, ensuring all activities are completed and documented according to Stryker's 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 or support capital acquisition activity from specifying equipment, contract negotiation, installation, and validation.
* Analyzes equipment to establish operating data, conducts experimental tests, and analyzes results.
* 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.
Requirements
* Bachelor's degree in Mechanical Engineering or a related engineering discipline with 4 or more years' experience.
* Preferred skills:
o Proven track record of working in a team-based environment.
o Excellent interpersonal skills - able to express ideas and collaborate effectively with multidisciplinary teams.
o Open-minded with the ability to recognize good ideas.
o Innovative thinker - able to envision new and better ways of doing things.
o Experience in executing complex problem-solving techniques related to manufacturing/design technical issues.
o Good instincts and sound judgment for mechanical and structural design.
o Good understanding of Design for Manufacturing (DFM), related statistical tools, and validation/verification techniques.
o Analytical skills, ability to plan, organize, and implement concurrent tasks.
o Good knowledge of manufacturing processes, materials, product, and process design.
o Able to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing.
o Experience in validation activities.