JOB Description:
Responsible for the post market activities of existingDesign History FilesforMedical Devicesunder the direction of a project leader or manager. Previous system experience withVault is preferred. Excellent communication, teamwork, and organizational skills are essential. Candidates must be self-starters and self-motivators.
Principal Duties 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
Skills:
Expected Areas of Competence
- 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
Education:
Education Requirements
B.S. degree from an ABET accredited school (or global equivalent) in Biomedical, Mechanical, or Materials engineering, or equivalent.
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