Senior Development Engineer

Job TitleResponsible 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 ResponsibilitiesAuthor and review existing Design History Files, identify scope, and mark gaps where necessary documents are missingUtilize Vault Systems to manage document workflowGenerate or analyze and update existing risk documentation (DFMEA or risk tables)Coordinate, prepare, and conduct design reviews with cross-functional teamsPerform functional relationship analyses (FRA) and tolerance stack-upsGenerate comprehensive protocols to test/analyze the product for design verification and design validation (V&V)Update prints and other design and manufacturing elementsRequirementsFamiliarity with Vault SystemsFamiliarity with drafting standards and geometric dimensioning and tolerancing (GD&T)Strong background in DHF documentation authoring and executing for Medical DevicesAbility to effectively work within a team to expedite completion of critical project tasks with cross functional groups including Regulatory and QualityEstablishing a process method which meets performance and quality requirementsAbility to give clear and concise oral presentationsTechnical writingMicrosoft Office SuiteB.S. degree from an ABET accredited school (or global equivalent) in Biomedical, Mechanical, or Materials engineering, or equivalent.