This job listing has expired and may no longer be relevant!
18 Jan 2021
Temporary Electrical Engineer Compliance Lead (21-01267)
Job Description
Long Term Contract for an Electrical Engineer Compliance Lead (no corp. to corp. or 3rd party)
Work independently in a lead role for Electrical Compliance Submissions, or as part of a team to design, develop, and troubleshoot critical electrical designs. Identify, recommend, implement significant and/or complex new electrical design improvements or technologies to meet regulatory requirements. Develop cross-functional working relationships and provide effective communication to Senior Management.
Mandatory Skill/Experience:
- Bachelor’s Degree in Electrical Engineering
Preferred: Master’s Degree in Electrical Engineering
- Minimum 7+ years’ of relevant experience with Bachelor’s degree and 5+ of relevant experience with Master’s degree
- FDA and European Union Regulatory submission experience
- Research, specify, design, verify, and validate very low-power analog front-end design and battery-powered embedded systems per applicable regulatory standards for medical devices.
- Working experience in EMC/EMI design and testing for regulatory standards.
- Create, review and renew electrical design specifications and product requirements.
- Develop product specifications, design FMEAs, and V&V test protocols.
- Ensure that electrical design and test equipment meet applicable industry and medical device standards
- Communicate effectively to and participate in cross-functional development teams.
- Punctual and responsible. Comply with all applicable Corporate and Divisional Policies and perform other duties as assigned by the Management Team.
- Solid knowledge of regulations and industry standards for medical device development including but not limited to ISO 13485, ISO 14971, and FDA Guidance for medical device development.
- Knowledge with gap assessment and gap closure activities for international regulatory bodies.
Preferred Requirements:
- Mastery of fundamental Electrical Engineering principles.
- Experience in performing complex engineering calculations and relating results to design verification tests including statistical analysis and tolerance analysis
- Understanding of processes used in the design and manufacturing of medical devices, particularly those for very low-current, battery-powered handheld, wearable, and body-worn devices.
- Excellent written and verbal communication skills.
How to Apply
Please send your updated resume to iris.chen@axelon.com339 total views, 0 today