Job Description:
As a Staff Process Development Engineer, you will play a pivotal role in shaping the future of surgery by developing 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.
This role requires you to investigate ways to manufacture/assemble electronics into powered instrumentation within an ecosystem of various supporting systems. You will collaborate with a global, multi-functional team working to build the best thing for our customers in powered ENT instrumentation.
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.
* 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 capital acquisition activity from specifying equipment, contract negotiation, Installation, and validation.
* Analyse equipment to establish operating data and 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.
Requirements:
* Bachelor's degree in Automation / Electrical / Electronic / Mechatronic Engineering or related field with 4 or more years' experience or a related master's degree.
* High level of manufacturing process competence with hands-on practical approach.
* Electronics Design for Manufacture/Assembly experience.
* Experience in process validation.
* Understanding of electronics schematics and technical documentation.
* PCB Design software experience beneficial.
* Proven track record of working in a team-based environment.
* Excellent interpersonal skills and ability 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) and related statistical tools.
* Excellent analytical skills and 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.