Katalyst CRO
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Staff Compliance Engineer
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Katalyst CRO 6 months ago Be among the first 25 applicants Overview
Staff Compliance Engineer responsible for leading regulatory compliance activities across medical device hardware and software, including IEC 60601-1 family, ISO 14971, and related standards. This role involves coordinating with mechanical, electrical, and software engineers, guiding lab testing, certifications, and technical documentation to support product development and regulatory approvals. Responsibilities
Expert in IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-2, ISO 14971 and experience with standards related to infusion pumps (IEC 60601-2-24). Develop strategies per applicable standards encompassing EMC and Safety. Electrical design review with deep understanding of layouts and schematics (EIT or PE preferred). Train cross-functional staff on various standards and perform impact assessments on standard updates. Read, interpret and communicate changes in technical regulations, directives and standards. Review new and existing designs for compliance with the latest directives and standards. Oversee lab control and certifications. Lead Safety and EMC testing projects with test labs, with some local travel required. During DCA, determine necessary testing for Safety and EMC requirements. Coordinate 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 for EMC/Wireless formal evaluations. Facilitate safety reviews of product systems and 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 hardware certification test requirements and validate testing reports for accuracy and completeness. Stay current on regulatory developments and new technologies. Ensure appropriate technical documentation exists for each project (e.g., design history files, risk analysis reports, software development records). Manage CAPA for product stewardship and electrical safety. Qualifications/Requirements
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. Proficiency in working with 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 (e.g., TUV, CSA, UL), updating technical files, and obtaining agency approvals. Attentiveness to detail with strong organizational skills. Ability to work proactively and independently. Excellent communication skills, both written and verbal; ability to convey technical information to both technical and non-technical personnel. Travel and Seniority
Travel as required for testing and certifications. Seniority level: Mid-Senior level Employment type: Contract Referrals increase your chances of interviewing at Katalyst CRO. Get notified about new Compliance Engineer jobs in San Diego, CA.
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Staff Compliance Engineer
role at
Katalyst CRO 6 months ago Be among the first 25 applicants Overview
Staff Compliance Engineer responsible for leading regulatory compliance activities across medical device hardware and software, including IEC 60601-1 family, ISO 14971, and related standards. This role involves coordinating with mechanical, electrical, and software engineers, guiding lab testing, certifications, and technical documentation to support product development and regulatory approvals. Responsibilities
Expert in IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-2, ISO 14971 and experience with standards related to infusion pumps (IEC 60601-2-24). Develop strategies per applicable standards encompassing EMC and Safety. Electrical design review with deep understanding of layouts and schematics (EIT or PE preferred). Train cross-functional staff on various standards and perform impact assessments on standard updates. Read, interpret and communicate changes in technical regulations, directives and standards. Review new and existing designs for compliance with the latest directives and standards. Oversee lab control and certifications. Lead Safety and EMC testing projects with test labs, with some local travel required. During DCA, determine necessary testing for Safety and EMC requirements. Coordinate 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 for EMC/Wireless formal evaluations. Facilitate safety reviews of product systems and 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 hardware certification test requirements and validate testing reports for accuracy and completeness. Stay current on regulatory developments and new technologies. Ensure appropriate technical documentation exists for each project (e.g., design history files, risk analysis reports, software development records). Manage CAPA for product stewardship and electrical safety. Qualifications/Requirements
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. Proficiency in working with 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 (e.g., TUV, CSA, UL), updating technical files, and obtaining agency approvals. Attentiveness to detail with strong organizational skills. Ability to work proactively and independently. Excellent communication skills, both written and verbal; ability to convey technical information to both technical and non-technical personnel. Travel and Seniority
Travel as required for testing and certifications. Seniority level: Mid-Senior level Employment type: Contract Referrals increase your chances of interviewing at Katalyst CRO. Get notified about new Compliance Engineer jobs in San Diego, CA.
#J-18808-Ljbffr