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

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

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.