Senior Manufacturing Engineer

Senior Manufacturing Engineer at VDyne Senior Manufacturing Engineer at VDyne in Osseo, Minnesota Posted in 8 days ago.

Type:

full-time

Job Description:

Company Description VDyne is a cutting-edge medical device company focused on developing innovative transcatheter valve solutions for treating Tricuspid Regurgitation (TR), a critical and life-threatening condition. Headquartered in Minneapolis, Minnesota, VDyne is revolutionizing the field with its proprietary side-delivery technology, enabling physicians to expand treatment access for TR patients. The company is actively conducting clinical studies across the United States, Europe, and Australia to refine and validate its advancements. VDyne is committed to improving patient outcomes and advancing the frontiers of minimally invasive cardiac care.

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

EXPERIENCE

:

• Minimum of 10 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.