Lead Evaluator & Reviewer - Medical Devices
Direct Hire/Salaried w/ Bonus
Remote: Hybrid remote, in the office 3 days per week
Locations: Fremont, CA | Northbrook, IL | Research Triangle Park, NC | Mounds View, MN
Employees: Globally – 13,0000
Team Size: 50 | Industry: Health and safety, scientific, consumer services, medical devices
Financial Information: $2B+ | Reports To: Engineering Manager | Travel: Negligible up to 10%
Responsibilities:
- Staff+ level Project Engineer acting as Lead Evaluator & Reviewer overseeing and conducting safety investigations for cutting-edge medical devices
- Coordinating, directing, and reviewing complex laboratory activities for staff members
- Training and mentoring junior laboratory staff and entry-level engineers
- Examining samples for compliance with safety requirements in the laboratory
- Communicating project status and results to clients through frequent contact and reports
- Analyzing project scope, determining specifications, and designing test programs
- Performing quality systems and technical audits of customer laboratories as needed
- Integrates continuous improvement concepts and techniques
- Resolving engineering issues associated with variation notices
- Assists in the development of requirements, special test methods, and test equipment
Qualifications:
- 10+ years of experience in compliance engineering
- Experience as Evaluator and Reviewer in the core standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11
- Additional experience with as Evaluator and Reviewer in 60601 series particular standards such as IEC 60601-2-2, IEC 60601-2-18, IEC 60601-2-47, ISO 80601-2-56, ISO 80601-2-61, ISO 80601-2-12, ISO 80601-2-74, IEC 60601-2-77, IEC 60601-2-78, IEC 60601-2-33, IEC 60601-2-37, IEC 60601-2-43, IEC 60601-2-44, IEC 60601-2-45, IEC 60601-2-37, IEC 60601-1-3
- Bachelor’s degree in electrical engineering, biomedical engineering, or a similar field is preferred
- Basic knowledge of laboratory testing apparatus and techniques for medical devices
- Ability to lead in a technical environment and provide unique solutions to complex problems
- Strong communications skill and ability to interact with customers
- Experience testing electrical and connected medical device products such as patient monitors, robotic surgical machines, infusion pumps, anesthesia machines, pacemakers, CT scanners, insulin pumps, hospital beds, ventilators, respirators, or CPAP machines
Compensation:
- $175K - $200K + 10-20% Bonus
