Sr. Engineering Regulatory Specialist(Direct Hire)
Itasca, IL
Job Requisition:7327
Annual Salary Range: $150 – 166K. Individual salaries are based on education, geographic location, and alignment to the market data.
Description for Sr. Engineering Regulatory Specialist:
Hands-on expert responsible for insuring that our products comply with evolving global technical requirements and regulations.
Responsibilities forSr. Engineering Regulatory Specialist:
- Maintain in-depth and detailed current knowledge of all technical regulations and guidance relevant to the Organ Recovery Systems (ORS) equipment and disposable products. Regulations include, for example: IEC-60601 and all its subsidiary standards; ISO-14971, UL and TUV requirements for medical devices; IEC electrical standards, applicable ASTM standards and test methods, and the rapidly evolving FDA and European requirements for software.
- Actively monitor changes and trends in evolving medical device technical regulations.
- Actively assess and monitor continued compliance of ORS equipment and disposable as the standards and products change.
- Assess design changes for compliance to technical standards during the development process.
- Identify gaps in compliance to technical standards and then take the lead in timely correcting products and documentation to maintain conformance, either hands-on or directing others.
- Hands-on role in product testing, including developing tests, performing tests, and directing external test labs and regulatory bodies.
- Hands-on role in updating, improving, and maintaining ORS product technical documentation, including requirements and specifications, usability testing, protocols and reports for verification, and trace matrices.
- When product changes are required for compliance, provide specific technical input to engineers responsible for those design changes.
- Take the lead in developing more efficient internal processes and tools for developing and tracking technical documentation, such as automation of trace matrix linkages.
- Actively educate other members of staff on applicable technical regulations.
Requirements forStaff Electrical Engineer:
- Technical degree, BS minimum, preferably in Electrical or Software engineering.
- Minimum 8 years work experience in test engineering or equivalent.
- Demonstrated deep technical knowledge of medical device standards and regulations.
- Demonstrated ability to write test protocols and perform electrical, system, and software tests.
- Work experience at a test laboratory is preferred.
- Proficient with spreadsheets. Proficiency with statistical tools such as MiniTab is preferred.
- Proficient communicator, verbal and written.
