Senior Medical Device Development Engineer - DHF & V&V

Creative Solutions Services, LLC; Warsaw (IN); On-site; USD 60,000 - 90,000; Full time

Job summary

Creative Solutions Services, LLC seeks a DHF Documentation Specialist to manage and author design history files for medical devices. You will utilize Vault for document workflow, review risk documentation, and coordinate design reviews with Regulatory and Quality teams.

The role emphasizes technical writing, GD&T familiarity, and effective cross-functional collaboration to expedite critical project tasks and maintain compliance.

Qualifications

• Familiarity with Vault Systems
• Familiarity with drafting standards and GD&T
• Strong DHF documentation authoring background for Medical Devices
• Ability to work with cross-functional teams incl. Regulatory and Quality
• Establish process methods meeting performance and quality requirements
• Ability to give clear and concise oral presentations
• Technical writing
• Microsoft Office Suite

Responsibilities

• Author and review existing DHF, identify scope and gaps
• Utilize Vault Systems to manage document workflow
• Generate or analyze risk documentation (DFMEA or risk tables)
• Coordinate, prepare, and conduct design reviews with cross-functional teams
• Perform FRA and tolerance stack-ups
• Generate protocols to test/analyze product for V&V
• Update prints and other design/manufacturing elements

Skills

Strong communication

Teamwork

Oral presentations

Technical writing

Microsoft Office Suite

Education

ABET-accredited B.S. in Biomedical, Mechanical, or Materials Engineering

Tools

Vault Systems

Drafting standards knowledge

Job description

Creative Solutions Services, LLC seeks a DHF Documentation Specialist to manage and author design history files for medical devices. You will utilize Vault for document workflow, review risk documentation, and coordinate design reviews with Regulatory and Quality teams.

The role emphasizes technical writing, GD&T familiarity, and effective cross-functional collaboration to expedite critical project tasks and maintain compliance.