Process Development / Manufacturing Engineer

VDyne; Maple Grove (MN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Incentive options

Comprehensive benefits

Job summary

VDyne in Maple Grove, Minnesota, is seeking a Manufacturing Engineer to join an innovative team focused on developing percutaneous tricuspid valves. The role involves process development, manufacturing support, and maintaining design assurance. Candidates should have a B.S. in engineering or related field, experience in Class III medical devices, and strong skills in SolidWorks, statistical methods, and quality regulations. Competitive salary and comprehensive benefits are offered.

Qualifications

• B.S. in Engineering or minimum of 5 years related medical device experience.
• Minimum of 2 years related medical device manufacturing engineering experience.
• Class III medical device manufacturing experience necessary.

Responsibilities

• Develop and refine processes for catheter assembly and valve assembly.
• Create and implement controlled manufacturing processes.
• Provide direction and training to production staff.

Skills

Test Method Validation (TMV)

Inspection Method Validation (IMV)

Gage R&R

Attribute Agreement Analysis (AAA)

Solidworks

Design of Experiments (DOE)

Mechanical Design Skills

Education

B.S. in Engineering Related Field

Tools

SolidWorks

MS Office Suite

Statistical Software

Job description

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.