Staff Compliance Engineer
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: San Diego, CA 92154
Description:
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.
- Bachelor's degree in engineering or related field from an accredited university or college.
- Minimum 8 years' experience working on medical device software and hardware development projects.
- Experience with ISO 14971, ISO 17025, IECEE procedures and audits, IEC 62304, Usability IEC 62368
- Should be proficient in working with both IEC 62304 and IEC/EN 60601 for medical device manufacturing.
- Working knowledge of regulatory requirements such as FDA 510(k) submissions and EU MDR/IVDR.
- Strong understanding of development life cycle.
- Experience with working with test labs, NRTLs (i.e. TUV, CSA, UL, etc.), updating technical files, and obtaining agency approvals.).
- Attentiveness to details with strong organizational skills.
- Ability to work proactively and independently.
- Excellent communication skills, both written and verbal.
- Must be able to communicate technical information effectively to both technical and non-technical personnel.
- Travel Requirements: