Process Development / Manufacturing Engineer

POSITION SUMMARY

The primary responsibilities will be process development, manufacturing support, and design insurance of percutaneous tricuspid valve replacement system.

HIGHLY PREFERRED SKILLS

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

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 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

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

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.

SUMMARY

This position is an opportunity to be part of a great innovative team and solve a critical problem in the structural heart space. Compensation includes a market competitive salary, comprehensive benefits including health insurance, and incentive options. #J-18808-Ljbffr VDyne