Staff Engineer, Process Development

Stryker

Carrigtohill, Ireland

We seek a talented individual to be part of our dynamic Advanced Operation global team, working closely with design engineers, subject matter experts and manufacturing stakeholders. Your primary responsibility will be to develop manufacturing approaches and concepts for next-generation surgical instruments. These instruments will push the boundaries of what’s possible in the realm of patient care. You will play a pivotal role in shaping the future of surgery.

We are working on new designs and technologies and ways to integrate these technologies into a seamless experience for our customers. We are looking for a curious and passionate individual to investigate how to create this experience as part of a team. This is your opportunity to join a rapidly growing unit within Stryker with an opportunity for growth in many directions.

This role will require you to investigate ways to manufacture/assemble electronics into powered instrumentation within an ecosystem of various supporting systems including EM navigation, endoscopic visualization and waste management, all used within a customer environment. You will collaborate within a global, multi-functional team working to build the next best thing for our customers in powered ENT instrumentation. Are you ready for the challenge?

What You Will Do

Developing manufacturing solutions for electronics components and associated assembly processes.
Identify and build relationships with key component suppliers.
Independently determines and develops approaches to a variety of technical problems of moderate scope and complexity.
Uses latest engineering techniques to reduce product time to market whilst 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.
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.
Ensure quality of process and product as defined in the appropriate operation and material specifications.
Will 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.
Will analyse equipment to establish operating data, conduct experimental test 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.
All other duties as assigned.

What You Will Need

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.
Have a 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. Be open minded with the ability to recognise 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 judgement 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, organise 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 can understand geometrical dimensioning and tolerancing.
Certified in validation activities.
Experience in an FDA regulated or regulated industry beneficial.
Excellent attention to detail.