Sr. Development Engineer

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. They are seeking a Sr. Development Engineer responsible for post market activities of existing Design History Files for Medical Devices, including authoring documentation and conducting design reviews.

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:

• Responsible for the post market activities of existing Design History Files for Medical Devices under the direction of a project leader or manager
• Excellent communication, teamwork, and organizational skills are essential
• Candidates must be self-starters and self-motivators
• 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
• 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
• Previous system experience with Vault is preferred
• Familiarity with Vault Systems
• Familiarity with drafting standards and geometric dimensioning and tolerancing (GD&T)