Note: The job is a remote job and is open to candidates in USA. Akkodis is seeking a Development Engineer for a remote 10 month project with a medical device client in Warsaw, IN. The role involves managing post market activities of existing Design History Files for Medical Devices, including documentation authoring, risk documentation updates, and coordinating 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
Skills
- B.S. degree from an ABET accredited school (or global equivalent) in Biomedical, Mechanical, or Materials engineering, or equivalent, and one to four years of medical device experience
- Excellent communication, teamwork, and organizational skills are essential
- Candidates must be self-starters and self-motivators
- Familiarity with Vault Systems preferred. If not, 2-5 years PLM like Windchill and electronic connection experience
- 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
Benefits
- Medical
- Dental
- Vision
- Life insurance
- Short-term disability
- Additional voluntary benefits
- An EAP program
- Commuter benefits
- A 401K plan
- Paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law
- Holiday pay where applicable
Company Overview