Note: The job is a remote job and is open to candidates in USA. Fusion Life Sciences Technologies LLC is seeking a Design Quality Engineer to support post-market activities for existing Medical Device Design History Files. The role involves managing documentation, risk analyses, design reviews, functional relationship analyses, tolerance stack-ups, verification and validation protocols, and updates to design and manufacturing elements.
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
- Excellent communication, teamwork, and organizational skills are essential
- Candidates must be self-starters and self-motivators
- 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
- Previous system experience with Vault is preferred
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