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Position Title: Development Engineer
Work Location: 100 % Remote
Assignment Duration: 08+ Months
Position Summary: 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.
Key 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
Qualification & Experience:
· 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.