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
REQUIREMENTS:
EDUCATION:
* B.S. in Engineering Related Field or minimum of 5 years of related medical device experience.
EXPERIENCE:
* Minimum of 2 years related medical device manufacturing engineering experience
* Class III medical device manufacturing experience necessary.
RESPONSIBILITIES:
* Process Development
* 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
* Manufacturing
* 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.
* Design Assurance
* Contribute on design assurance activities such as documentation of product specifications, failure modes analysis, and test method development.
* Project Responsibilities:
* Plan, schedule, and complete project activities
KNOWLEDGE, SKILLS, AND ABILITIES:
* Direct knowledge of catheters, and interventional delivery system construction.
* Strong math and statistical (DOE) skills.
* Strong written and verbal communication skills
* Software Skills - SolidWorks, statistical software, and MS Office Suite
* Strong mechanical design skills including prototype development, test method and testfixture design
* Working knowledge of FDA Quality System Regulation 21 CFR Part 820, ISO 13485, and ISO 14791
PERSONAL ATTRIBUTES:
* Strong analytical and critical thinking skills
* Adapts to evolving environment and a broad range of activities
* Driven - approaches activities with a sense of urgency
* Hands- on approach
* Good interpersonal skills
*Cannot support sponsorship needs
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