Senior Compliance Engineer

Abbott; Plano (TX); Presencial; USD 78.000 - 156.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

HIP PPO medical plan

Excellent retirement plan

Tuition reimbursement

FreeU education

Descripción de la vacante

Abbott in Plano, TX is seeking a Senior Compliance Engineer to lead regulatory compliance for neuromodulation products. You will collaborate with design, quality, regulatory, and manufacturing teams to ensure safety and regulatory readiness across the product lifecycle.

The role emphasizes testing strategy, standards interpretation, risk assessment, and close engagement with external laboratories to secure certifications for global markets. Strong writing and communication skills are essential.

Formación

• Bachelor’s degree in Electrical Engineering or related engineering discipline required.
• Minimum 5 years of experience in product compliance, electrical engineering, or 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.

Responsabilidades

• Serve as a technical lead and SME for product compliance across new product development and sustaining projects.
• Evaluate designs against applicable national and international standards (electrical safety, EMC, wireless, environmental, medical device requirements).
• Develop compliance strategies, test plans, protocols, and reports to support verification, validation, regulatory submissions, and market access.
• Collaborate with systems, electrical, firmware, mechanical, quality, regulatory, and manufacturing teams to embed compliance early.
• Partner with external labs, certification bodies, and regulatory organizations to plan and complete testing and certifications.
• Conduct impact assessments for changes, substitutions, manufacturing changes, and design modifications for compliance implications.
• Monitor standard revisions and regulatory changes; plan implementation to maintain compliance.
• Investigate compliance issues, perform root-cause analyses, and implement corrective actions.
• Communicate requirements, risks, results, and recommendations across the organization.

Conocimientos

Regulatory standards interpretation

Test planning

Cross-functional collaboration

Technical writing

Educación

Bachelor's degree in Electrical Engineering

Descripción del empleo

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.

JOB DESCRIPTION:

Job Title

Senior Compliance Engineer

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• 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, 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

Minium 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

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

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

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)

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

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