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. .
Roles 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
Requirements:
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.
