Job TitleSenior Compliance EngineerWhat You'll Work OnThis 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
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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)
