Summary
Turnberry Solutions is a consulting firm specializing in digital modernization, and they are seeking a Design Engineer to join their Digital Modernization practice. The role involves managing design documentation, conducting design reviews, and ensuring product verification and validation.
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
- 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
Qualifications
Must Haves
- 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
Benefits
- Comprehensive healthcare package (medical, dental, vision)
- Disability and group term life insurance
- Health and flexible spending accounts
- Utilization bonus
- 401(k) with match
- Flexible time off for salaried employees
- Parental leave for salaried employees
- Flexible work arrangements (all benefits are subject to eligibility requirements)