Senior Compliance Engineer

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 122000 colleagues serve people in more than 160 countries.

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. Youll 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 the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors 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 Youll 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

• Bachelors 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 IECFCC 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:

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.

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The base pay for this position is

$78000.00 $156000.00

In specific locations the pay range may vary from the range posted.

Product Development

NM Neuromodulation

United States > Texas > Plano : 6901 Preston Road

Standard

Not specified

Not Applicable

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: EEO is the Law link - Espanol: Experience:

Senior IC