Process Development Engineer

Process Development/ Manufacturing Engineer (I,II, III and Sr.) Highly Preferred Skills

• Test Method Validation (TMV)
• Inspection Method Validation (IMV)
• Gage R&R
• Attribute Agreement Analysis (AAA)
• OQ
• PQ
• Solidworks
• DOE

B.S. in Engineering Related Field or minimum of 5 years of related medical device experience.

• Minimum of 2 years related medical device manufacturing engineering experience
• Class III medical device manufacturing experience necessary.

• Develop and refine processes for catheter assembly, nitinol metals processing, valve assembly and/or biological tissue processing
• Define, create, and implement manufacturing fixturing, tooling, and equipment
• Develop a fundamental understanding of the processes to ensure a stable operating platform

• Support prototype and pilot production, verification builds and clinical builds
• Address component and/or raw material issues with suppliers
• Create and implement controlled manufacturing processes
• Provide direction and training to production staff
• Manage change control at the production level
• Develop and execute process and equipment validation plans and protocols.

• Contribute on design assurance activities such as documentation of product specifications, failure modes analysis, and test method development.

• Plan, schedule, and complete project activities

• Direct knowledge of catheters, and interventional delivery system construction.
• Strong math and statistical (DOE) skills.
• Strong written and verbal communication skills
• Software Skills - Solid Works, statistical software, and MS Office Suite
• Strong mechanical design skills including prototype development, test method and test fixture design
• Working knowledge of FDA Quality System Regulation 21 CFR Part 820, ISO 13485, and ISO 14791

• Strong analytical and critical thinking skills
• Adapts to evolving environment and a broad range of activities
• Driven - approaches activities with a sense of urgency