Responsible for the post market activities of existing Design History Files for Medical Devices under the direction of a project leader or manager.
Previous system experience with Vault is preferred.
Excellent communication, teamwork, and organizational skills are essential.
Candidates must be self-starters and self-motivators. .
Roles and Responsibilities:
Author and Review existing Design History Files, identify scope, and mark gaps where necessary documents are missing
Utilize Vault Systems to manage Document workflow
Generate or analyze and update existing risk documentation (DFMEA or risk tables)
Coordinate, prepare, and conduct design reviews with cross-functional teams
Perform functional relationship analyses (FRA) and tolerance stack-ups
Generate comprehensive protocols to test/analyze the product for design verification and design validation (V&V)
Update prints and other design and manufacturing elements
Requirements:
Familiarity with Vault Systems
Familiarity with drafting standards and geometric dimensioning and tolerancing (GD&T)
Strong Background in DHF documentation authoring and executing for Medical Devices
Ability to effectively work within a team to expedite completion of critical project tasks with cross functional groups including Regulatory and Quality
Establishing a process method which meets performance and quality requirements
Ability to give clear and concise oral presentations
Technical writing
Microsoft Office Suite
B.S. degree from an ABET accredited school (or global equivalent) in Biomedical, Mechanical, or Materials engineering, or equivalent.
Numbers & Facts
Location
Warsaw, IN
Skills
ABET (Accreditation Board for Engineering and Technology)unmatched
Analysis Skillsunmatched
Biomedicineunmatched
Communication Skillsunmatched
Cross-Functionalunmatched
Design Failure Mode and Effects Analysis (DFMEA)unmatched
Design Verificationunmatched
Documentationunmatched
Functional Analysisunmatched
Geometric Dimensioning and Tolerancingunmatched
Manufacturingunmatched
Materials Engineeringunmatched
Medical Equipmentunmatched
Medical Recordsunmatched
Microsoft Officeunmatched
Organizational Skillsunmatched
Process Developmentunmatched
Product Designunmatched
Regulationsunmatched
Riskunmatched
Team Playerunmatched
Technical Writingunmatched
Testingunmatched
Validation Testingunmatched
Writing Skillsunmatched
🎯
Be found by employers
5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.