Staff Process Development Engineer
We are seeking a talented Process/Automation Engineer with experience in Electronics manufacturing to join our Advanced Operations global team.
The successful candidate will develop new ways of realising the design of electronic components to manufacturing for our ENT powered instruments, working closely with design engineers, subject matter experts, and manufacturing stakeholders.
This role requires investigating ways to manufacture/assemble electronics into powered instrumentation within an ecosystem of various supporting systems, including EM navigation, endoscopic visualization, and waste management. The candidate will collaborate within a global, multi-functional team to build the next best thing for our customers in powered ENT instrumentation.
Duties and Responsibilities:
* Develop manufacturing solutions for electronics components and associated assembly processes.
* Identify and build relationships with key component suppliers.
* Independently determine and develop approaches to technical problems of moderate scope and complexity.
* Apply 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 all activities are completed and documented in accordance with Stryker new product development procedures.
* Ensure 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. 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.
* Analyse equipment to establish operating data, conduct experimental tests, 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.
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 knowledge of manufacturing processes, materials, product, and process design.
* Must be 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.