Staff Compliance Engineer
| Company | Becton Dickinson |
|---|---|
| Location | San Diego, CA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- Bachelor’s Degree in Engineering or related field from an accredited university or college
- Minimum of 6 years of compliance (safety or EMC) engineering experience
Responsibilities
- Expert in IEC 60601-1, IEC 60601-1-2, IEC 61010-1, ISO 14971 and experience with particular standards
- Expert in developing strategies according to business per applicable standards encompassing EMC, MOC 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
- Lead projects with test labs -some local travel required
- Coordinate any required 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 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
- Support environmental compliance for RoHS, WEEE, REACH and Prop65
Preferred Qualifications
- Experience with working with test labs, NRTLs (ie 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 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.