Staff Compliance Engineer

BD; United States; Remote; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Staff Compliance Engineer to ensure global regulatory compliance for innovative medical products. This role involves collaborating with R&D teams, leading projects with test labs, and navigating complex safety and environmental regulations. The ideal candidate will possess extensive experience in compliance engineering, particularly with IEC and ISO standards, and demonstrate strong communication skills to effectively liaise with various stakeholders. Join a forward-thinking company dedicated to advancing health technology and making a meaningful impact in the industry.

Benefits

Health Insurance

Retirement Plans

Paid Time Off

Professional Development

Flexible Work Hours

Qualifications

• 6+ years of compliance engineering experience required.
• Expertise in IEC and ISO standards is essential.
• Strong organizational skills and attention to detail.

Responsibilities

• Lead projects with test labs and ensure compliance.
• Review designs for adherence to safety standards.
• Train staff on regulatory changes and compliance.

Skills

Compliance Engineering

Safety Standards

EMC Testing

Electrical Design Review

Regulatory Compliance

Communication Skills

Project Management

Education

Bachelor's Degree in Engineering

Tools

Excel

Word

Job description

Job Description Summary

The 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.

Job Description

We are the makers of possible

BD 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.

Excited to grow your career?

We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply!

Business & Product Overview

Pyxis 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/pyxis

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 of layouts and schematics (EIT or PE preferred)
• Able to 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 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 ownership of issues, and contribute towards investigation and resolution.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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/careers

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.