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&RAttribute Agreement Analysis (AAA)OQPQSolidworksDOEREQUIREMENTS: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 activitiesKNOWLEDGE, 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 14791PERSONAL 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