BD
Staff Compliance Engineer
BD, San Diego, California, United States, 92189
Job Description Summary
Job Description
We are
the makers of possibleBD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a
maker of possible
with us.Job DescriptionThe Staff Compliance Engineer will participate in projects acquiring global regulatory compliance approvals for new and updated products. The job requires experience with performing or supporting the design and testing required to obtain safety, EMC/wireless and similar certifications. Experience with the relevant UL, CSA, FCC, IEC and EN directives and standards is required.
Broader experience with RoHS, WEEE, REACH, Prop65 and other environmental regulations is differentiating. The engineer will participate in advising R&D teams on development practices, developing test plans encompassing safety, EMC, wireless, environmental, and other product compliance requirements.
It will involve communicating with test labs and other compliance stakeholders to achieve these objectives.Business & Product OverviewPyxis® medication technologies combine proven technology with actionable intelligence to prevent medication errors, help free up caregiver time to focus on patient care, increase the predictability of medication availability, and reduce inefficiencies in the med use process. At almost every point in the med use process, safety and efficiency can be increased with the comprehensive capabilities of the Pyxis® medication management system. Learn more about Pyxis®: https://www.bd.com/en-us/products-and-solutions/products/product-brands/pyxisResponsibilitiesExpert 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 prefered)
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
Required Qualifications: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
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.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.Why Join Us?A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.To learn more about BD visit https://bd.com/careersBecton, 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.Required SkillsOptional Skills.Primary Work Location
USA CA - San Diego TC Bldg C&D
Additional Locations
Work Shift
At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.Salary Range Information$121,100.00 - $199,800.00 USD Annual
Job Description
We are
the makers of possibleBD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a
maker of possible
with us.Job DescriptionThe Staff Compliance Engineer will participate in projects acquiring global regulatory compliance approvals for new and updated products. The job requires experience with performing or supporting the design and testing required to obtain safety, EMC/wireless and similar certifications. Experience with the relevant UL, CSA, FCC, IEC and EN directives and standards is required.
Broader experience with RoHS, WEEE, REACH, Prop65 and other environmental regulations is differentiating. The engineer will participate in advising R&D teams on development practices, developing test plans encompassing safety, EMC, wireless, environmental, and other product compliance requirements.
It will involve communicating with test labs and other compliance stakeholders to achieve these objectives.Business & Product OverviewPyxis® medication technologies combine proven technology with actionable intelligence to prevent medication errors, help free up caregiver time to focus on patient care, increase the predictability of medication availability, and reduce inefficiencies in the med use process. At almost every point in the med use process, safety and efficiency can be increased with the comprehensive capabilities of the Pyxis® medication management system. Learn more about Pyxis®: https://www.bd.com/en-us/products-and-solutions/products/product-brands/pyxisResponsibilitiesExpert 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 prefered)
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
Required Qualifications: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
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.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.Why Join Us?A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.To learn more about BD visit https://bd.com/careersBecton, 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.Required SkillsOptional Skills.Primary Work Location
USA CA - San Diego TC Bldg C&D
Additional Locations
Work Shift
At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.Salary Range Information$121,100.00 - $199,800.00 USD Annual