Senior Compliance Engineer - Medical Devices (EMC/Safety)

Abbott; Plano (TX); Vor Ort; USD 78.000 - 156.000; Vollzeit

Benefits dieser Stelle

HIP PPO medical plan

Excellent retirement plan

Tuition reimbursement

FreeU education

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory standards interpretation

Test planning

Cross-functional collaboration

Technical writing

Ausbildung

Bachelor's degree in Electrical Engineering

Jobbeschreibung

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.