Sr. Development Engineer

Sr Development Engineer

8 Months Contract
100% Remote

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 is preferred. 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

Skills: 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: Education Requirements

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