Job Title: Staff Process Development Engineer
We are seeking a talented individual to join our Advanced Operations global team as a Staff Process Development Engineer. As a key member of our dynamic team, you will work closely with design engineers, subject matter experts, and manufacturing stakeholders to develop manufacturing approaches and concepts for next-generation surgical instruments.
The ideal candidate will have a strong background in Process/Automation Engineering and experience in Electronics manufacturing. You will play a pivotal role in shaping the future of surgery by developing new ways of realizing electronic component designs for manufacturing within an ecosystem of various supporting systems.
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 provide guidance and training to other team members.
* 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 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 tests, 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.
* Ensure adherence to GMP and safety procedures.
* Review and approval of validation documentation.
* All other duties as assigned.
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 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.
* Excellent attention to detail.
Travel Requirements:
* Ability to travel to US with 6 – 8 weeks' notice is essential.
* Up to 20% travel associated with this role.