Senior Compliance Engineer

Abbott Laboratories; Plano (TX); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Career development

Free medical coverage

Strong retirement plan

Tuition reimbursement

Education benefit

Diversity recognition

Job summary

Abbott in Plano, TX is seeking a Senior Compliance Engineer to ensure Neuromodulation products meet regulatory standards throughout the lifecycle. You will lead compliance strategy, interpret standards, plan tests, and collaborate with development, quality, regulatory, and external labs to deliver safe, compliant medical devices.

The role requires a Bachelor’s degree in Electrical Engineering and 5+ years in product compliance or a regulated environment, with strong written and oral

Qualifications

• Bachelor’s degree in Electrical Engineering or related field.
• Minimum 5 years in product compliance or electrical engineering.
• Experience interpreting regulatory requirements for electronic products.
• Experience developing and executing compliance testing programs.
• Experience coordinating with external test labs and certification bodies.
• Experience performing risk assessments and impact analyses.
• Experience in regulated product development environments.
• Strong written and verbal communication skills.

Responsibilities

• Serves as technical lead for product compliance across development projects.
• Evaluate designs against electrical safety, EMC, wireless and medical device standards.
• Develop compliance strategies, test plans, and reports for regulatory submissions.
• Collaborate with systems, electrical, firmware, mechanical, QA, regulatory and manufacturing teams.
• Coordinate with external laboratories and certification bodies for testing and certification.
• Conduct impact assessments for changes and ensure required testing.
• Monitor standard updates and maintain compliance plans.
• Investigate compliance issues and implement corrective actions.
• Communicate requirements and findings across the organization.

Skills

Regulatory compliance

Electrical engineering

EMC

Test planning

Regulatory submissions

Cross-functional teamwork

Risk assessment

Technical writing

Interpret standards

Education

Bachelor’s degree in Electrical Engineering

Job description

Job Title

Senior Compliance Engineer Working at Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Benefits

• Career development with an international company where you can grow the career you dream of.


• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.


• An excellent retirement savings plan with high employer contribution.


• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.


• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.


• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

What You’ll Work On

This position works out of our Plano, TX location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non‑opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

The Senior Compliance Engineer is responsible for ensuring Abbott Neuromodulation products comply with applicable medical device safety, EMC, wireless, environmental, and other regulatory standards throughout the product lifecycle. This role provides technical leadership in product compliance strategy, standards interpretation, testing, and impact assessments while collaborating closely with product development teams, external test laboratories, quality, regulatory, and manufacturing organizations to deliver safe and compliant medical device solutions.

• Serves as a technical lead and subject matter expert for product compliance activities across new product development and sustaining engineering projects


• Evaluates product designs against applicable national and international standards, including electrical safety, electromagnetic compatibility (EMC), wireless, environmental, and medical device‑specific requirements


• Develops compliance strategies, test plans, protocols, and reports to support product verification, validation, regulatory submissions, and market access activities


• Collaborates closely with systems, electrical, firmware, mechanical, quality, regulatory, and manufacturing teams to ensure compliance requirements are incorporated throughout the design and development process


• Partners with external test laboratories, certification bodies, and regulatory organizations to plan, execute, and successfully complete compliance testing and product certifications


• Conducts impact assessments for product changes, component substitutions, manufacturing changes, and design modifications to determine compliance implications and required testing


• Monitors revisions to applicable standards and regulations, evaluates their impact on existing and future products, and develops implementation plans to maintain compliance


• Investigates compliance‑related issues, supports root cause analysis activities, and develops corrective actions to address identified gaps or nonconformances


• Effectively communicates compliance requirements, risks, testing results, and recommendations across all levels of the organization to support informed decision‑making and successful product development

Qualifications

• Bachelor’s degree in Electrical Engineering or related engineering discipline


• Minimum 5 years of experience in product compliance, electrical engineering, or a related field


• Experience interpreting and applying technical standards and regulatory requirements to electronic products


• Experience developing and executing compliance testing programs, including test plans, protocols, and reports


• Experience working with external test laboratories and certification organizations


• Experience performing engineering assessments, risk evaluations, and impact analyses for product or process changes


• Experience working in a regulated product development environment


• Strong analytical, problem‑solving, technical writing, and communication skills

Preferred Qualifications

• 7+ years of experience supporting compliance activities for complex electronic or medical device products


• Experience with Class II or Class III medical devices. Strong knowledge of medical device standards, including IEC 60601 series, ISO 14708 series, IEC 62304, ISO 10993, IEC 60601‑1‑2, FCC, RED, and other applicable regulatory requirements


• Experience supporting implantable, externally worn, or wireless medical device systems


• Experience conducting EMC, electrical safety, environmental, reliability, and wireless compliance evaluations


• Experience assessing the impact of standards revisions and regulatory changes on existing product portfolios


• Experience working with cross‑functional product development teams throughout the product lifecycle

Salary and Location

The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Product Development DIVISION: NM Neuromodulation LOCATION: United States > Texas > Plano : 6901 Preston Road ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)

Equal Opportunity and Diversity

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

Abbott welcomes and encourages diversity in our workforce.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Company Culture

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.