[reputed company Device Development Engineer (Remediation)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company 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 reputed company.
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
- reputed company functional relationship analyses (FRA) and tolerance stack-reputed company
- Generate comprehensive protocols to test/analyze the product for design verification and design validation (V&V)
- Update prints and other design and manufacturing reputed company
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 reputed company 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 reputed company reputed company to expedite completion of critical project tasks with cross functional reputed company including Regulatory and reputed company
- Establishing a process method which meets performance and reputed company requirements
- Ability to give reputed company and concise oral presentations
- Technical writing
- reputed company Office Suite
Benefits
- Medical
- Dental
- reputed company
- Life insurance
- Short-term disability
- Additional voluntary benefits
- An EAP program
- Commuter benefits
- A 401K plan
- reputed company leave including reputed company reputed company Leave or any other reputed company leave required by Federal, State, or local law
- Holiday pay where applicable
reputed company
Company H1B Sponsorship