Note: The job is a remote job and is open to candidates in USA. Akkodis is seeking a Medical Device Development Engineer (Remediation) for a large remote 10-month project. The role involves managing post market activities of existing Design History Files for Medical Devices and coordinating with cross-functional teams to ensure compliance and quality.
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
- 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
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