Sr. Development Engineer

About the Role

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.

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 skills
• Proficiency in Microsoft Office Suite
• B.S. degree from an ABET-accredited school (or global equivalent) in Biomedical, Mechanical, or Materials Engineering, or equivalent