The role of Staff Process Development Engineer is a permanent hybrid position based in Carrigtwohill, Cork. This position involves collaborating with design engineers, subject matter experts, and manufacturing stakeholders to develop new ways of realizing electronic component designs for manufacturing within our ENT powered instruments.
Key Responsibilities
* Develop manufacturing solutions for electronics components and associated assembly processes.
* Identify and build relationships with key component suppliers.
* Determine and develop approaches to technical problems of moderate scope and complexity.
* Use latest engineering techniques to reduce product time to market while adhering to regulatory requirements, project deadlines, and product costs.
* Build productive internal and external working relationships and may periodically provide guidance and train other team members.
* 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.
* Evaluate 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.
* Lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation, and validation.
* Analyse equipment to establish operating data, conduct experimental test and result analysis.
* 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.
* Evaluate adherence to GMP and safety procedures.
* Review and approval of validation documentation.
Requirements
* B.S in Automation / Electrical / Electronic / Mechatronic Engineering (Level 8), or related engineering discipline with 4 or more years' experience or a related master's degree.
* High level of manufacturing process competence, with a hands-on practical approach.
* Electronics Design for Manufacture/Assembly experience.
* Experienced in process validation.
* Experience in understanding electronics schematics and technical documentation.
* PCB Design software experience is beneficial.
* Proven track record of working in a team-based environment.
* Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams.
* 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 understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques.
* Excellent analytical skills, ability to plan, organise 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 beneficial.
Travel Requirements
* Able to travel to US with 6 – 8 weeks' notice is essential.
* Up to 20% travel associated with this role.
Job Code:
#J-18808-Ljbffr