Staff Compliance Engineer
San Diego, CA, USA | Becton Dickinson & Company
Job Description:88 people have viewed this job
The Staff Compliance Engineer will participate in projects obtaining CSA or similar agency approvals for new and updated products. The job requires experience with obtaining CE, EMC, RED, FCC, IC and safety certifications. Experience with the relevant UL, CSA, FCC, IEC and EN directives and standards related to medical devices. Experience with RoHS, WEEE, REACH, Prop65 and other environmental regulations is a plus. The engineer will participate in developing test plans encompassing EMC, EMI, safety, environmental, and other product compliance requirements.
- Read, interpret and communicate changes in technical regulations, directives and standards
- Review new and existing designs for compliance to the latest directives and standards
- Manage projects with test labs -some local travel required
- Coordinate any necessary changes with mechanical, electrical, and software engineers
- Drive product certifications across development teams, testing labs, suppliers and manufacturing partners
- Compile data and write reports regarding existing and potential engineering studies and projects
- Prepare and/or edit test procedures used during design and manufacturing processes that affect safety/compliance testing.
- 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 oversee the hardware and software certification test requirements and validate testing reports for accuracy, completeness, and ensure all mandatory requirements are properly accounted for in complete package
- Support environmental compliance for RoHS, WEEE, REACH and Prop65
- Bachelor's Degree in Engineering or related field from an accredited university or college
- 8+ years of compliance (safety or EMC) engineering experience
- Experience with working with test labs, updating technical files, and obtaining agency approvals
- Experience working in a regulated industry, FDA preferred
- Attentiveness to details with effective time management and organizational skills
- Ability to work proactively and independently
- Excellent verbal communication and interpersonal skills with the ability to work in a team environment
- Proficiency in Excel, Word, and other desktop/general business systems
- Track record of developing new skills quickly and cross-pollinate the learnings from one area to another.
- Ability and willingness to dig deeper, take the ownership of the issue on hand and make a meaningful contribution towards investigation and resolution of the issue.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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