Development Engineer (W2 Only)

Job 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. Excellent communication, teamwork, and organizational skills are essential. Candidates must be self-starters and self-motivators.

Principal Duties 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

Expected Areas of Competence

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

Education Requirements

B.S. degree from an ABET accredited school (or global equivalent) in Biomedical, Mechanical, or Materials engineering, or equivalent.

Navnish kumar

Sr. IT Technical Recruiter

Stellent IT Phone :

Email: navnish
Gtalk: navnish om