Process Development / Manufacturing Engineer

Process Development / Manufacturing Engineer at VDyne Process Development / Manufacturing Engineer at VDyne in Osseo, Minnesota Posted in 3 days ago.

Type:

full-time

Job Description:

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.