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Staff Compliance Engineer
| Company | Becton Dickinson |
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| Location | San Diego, CA, USA |
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| Salary | $121100 – $199800 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior, Expert or higher |
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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
- 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
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
Preferred Qualifications
