Live opening · Posted 3 days ago
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About the role
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Overview
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Client designs, develops, manufactures and markets orthopedics products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses. client has operations in more than 40 countries around the world
Job Title: Development Engineer
Location: Warsaw, IN 46580
Duration: 7 Months
Job Type: Temporary Assignment
Work Type: Remote
Pay Rate: $42.00 - $42.00/Hr
Job Description
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
Required 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 Requirements
B.S. degree from an ABET accredited school (or global equivalent) in Biomedical, Mechanical, or Materials engineering, or equivalent.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Work arrangement
Yes
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