Process Engineer (Medical Devices)

Process Engineer II

Determine operations to produce products and develop processes to ensure quality, cost and efficiency requirements. Lead and manage key process items to bring new products through the design phase into efficient manufacturing operations.

Key Accountabilities:

• Develop fixtures, gigs and gauges
• Document methods for manufacturing and inspection
• Log evaluations into Engineering Notebooks
• Design, evaluate, implement and monitor processes and operating systems for the manufacture aortic stent grafts
• Develop and implement new Mfg processes, execute process validations such as IQ, OQ, PQ protocols and reports
• Lead the design transfer phase including product development, validation planning, design for manufacturability and assembly, Design of Experiments, process capability analysis, etc.
• Conduct risk analysis including DFMEA, PFMEA and create/maintain necessary documentation.
• Support the conversion of small-scale processes into commercially viable large-scale operations.
• Work with Research and Development to develop and transfer new designs to manufacturing
• Perform statistical analyses on data groups
• Present data and projects to upper management when required
• Lead TMVs and software validation as necessary
• Monitor and improve the efficiency, output and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data from other technical and operating personnel.
• Support Quality system items such as CAPAs, NCRs, CQPs, TMVs, etc.
• Other various responsibilities and projects, as necessary Budget managed (if applicable NA Internal Networking/Key relationships:

This position requires cooperating with different company departments, such as Quality, R&D, Regulatory, Operations, Sales, Marketing, Finance and the other team members of the department

Qualifications

• Minimum Skills and Capabilities:
• Must work well under pressure
• Knowledge of AutoCad and SolidWorks
• Knowledge of engineering statistics
• Technical writing skills for manufacturing instructions, test methods, protocols, reports, etc. a must
• Able to work closely with a variety of people and teams within the company
• Ability to organize and conduct experiments independently
• Ability to analyze and solve technical problems
• Hands on abilities to engineer tooling, processes, and equipment
• Hands on experience building prototypes, tooling, and fixtures
• Excellent written and verbal communication skills
• Proficient in software applications
• Minimum Knowledge & Experience required for the position:
• 4 - year engineering degree or equivalent experience
• 5+ years of experience in a technical role in the medical device industry
• Project management experience in the medical device industry
• Experience and understanding of quality system regulations (e.g. 21CFR820, ISO13485).
• Project management experience in the medical device industry
• Experience with polymers, medical grade metals and medical packaging
• Hands-on knowledge of electronics, motion control, plastics, metallurgy, and manufacturing processes