Process Development Engineer (Staff)
Reports to Associate Manager, this is a 23 month Fixed Term Contract based in Carrigtwohill, Cork, Ireland.
Position Summary
An independently determined approach will be used to develop methods for solving technical problems of moderate scope and complexity.
Latest engineering techniques will be utilized to reduce product time to market while adhering to regulatory requirements, project deadlines, and product costs.
Key Areas of Responsibility
* 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.
* Evaluate the quality of processes and products as defined in operation and material specifications.
* Components and equipment selection will be based on analysis of specifications, reliability, and regulatory requirements.
* Collaborate with quality engineers to develop component-specific testing and inspection protocols.
* Lead or support capital acquisition activity from specifying equipment, contract negotiation, installation, and validation.
* Conduct equipment analysis to establish operating data, experimental testing, and result analysis.
* Participate in process review meetings.
* Contribute to 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 approve validation documentation.
* Perform other duties as assigned.
Required Skills
* Bachelor's degree in Mechanical Engineering or related engineering discipline with 4 or more years' experience.
Preferred Skills
* 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.
* 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 have the ability to understand geometrical dimensioning and tolerancing.
* Experience in validation activities.