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