What are the responsibilities and job description for the Staff Compliance Engineer position at Critical Fit Recruiting?
Staff Compliance Engineer - San Diego, CA (Hybrid)
DESCRIPTION :
The Staff Compliance Engineer will be responsible for working on software and hardware medical device systems. Projects include a variety of settings involving infusion pumps, networked devices, and embedded systems. Candidate will be responsible for ensuring all applicable regulations are met throughout the entire product lifecycle.
RESPONSIBILITIES :
- Expert in IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8, and IEC 60601-1-2, ISO 14971 and experience with particular standards related to infusion pumps (IEC 60601-2-24).
- Expert in developing strategies according to business per applicable standards encompassing EMC and Safety.
- Expert in Electrical design review including deep understanding on layouts and schematics (EIT or PE preferred).
- Able to train cross functional staff on various standards and perform impact assessment on standard updates.
- Read, interpret and communicate changes in technical regulations, directives and standards
- Review new and existing designs for compliance to the latest directives and standards
- Oversee lab control and certifications.
- Lead Safety and EMC testing projects with test labs -some local travel required.
- During DCA, provide determination on what testing is needed with regards to Safety and EMC requirements.
- Coordinate any required changes with mechanical, electrical, and software engineers
- Drive product certifications across development teams and testing labs
- Compile data and write reports regarding existing formal testing done at an accredited lab.
- Prepare and / or edit test procedures to be used for EMC / Wireless formal evaluations.
- Facilitate safety reviews of products systems and / or components as part of new product development, and modify / update existing products
- Lead cross-functional teams to address product compliance related issues
- Define and lead all aspects of the hardware certification test requirements and validate testing reports for accuracy, completeness, and ensure all mandatory requirements are properly accounted for in complete package
- Stay current on relevant regulatory developments and new technologies
- Ensure appropriate technical documentation exists for each project (e.g., design history files, risk analysis reports, software development records, etc.)
- Manage CAPA for product stewardship and electrical safety
BACKGROUND PROFILE :
