What are the responsibilities and job description for the Compliance Test Engineer/Medical Device Compliance Engineer position at Abbott?
Title: Compliance Test Engineer/Medical Device Compliance Engineer
Location: Plano, TX
Duration: 12 Months
100% Onsite
Duties
Coordinate and work with external test houses for compliance testing of medical products Write and maintain compliance test plans and test reports Release and manage documentation within the company’s document control system Analyze changes to relevant standards and regulations Perform regulatory and compliance impact assessments on existing and new products
Experience
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.
Location: Plano, TX
Duration: 12 Months
100% Onsite
Duties
Coordinate and work with external test houses for compliance testing of medical products Write and maintain compliance test plans and test reports Release and manage documentation within the company’s document control system Analyze changes to relevant standards and regulations Perform regulatory and compliance impact assessments on existing and new products
Experience
- 5-7 years of experience.
- Prior experience with medical device compliance testing highly desired
- Experience working with regulatory standards and external testing labs required
- 3-5 will consider but must have related experience
- Medical device compliance and regulatory testing
- Test plan development and reporting
- Standards and regulation analysis
- Documentation control and release processes
- Cross functional collaboration with test houses and internal teams
- Preferred Experience: Hands-on experience with the following standards is strongly preferred; Manufacturing background is a plus
- EN 300 328
- FCC 15.247
- EN 301 489 1 / EN 301 489 17
- ISO 14708 1
- ISO 14708 3
- Non Implantable Medical Devices:
- IEC 60601 1
- IEC 60601 1 2
- EMC / Immunity:
- IEC 61000 4 series
- Bachelor’s degree in Engineering or a related technical field preferred
- Medical and Prescription Drug Plans
- Dental Plan
- Vision Plan
- Health Savings Account (for High-Deductible Health Plans)
- Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
- Supplemental Life Insurance
- Short Term Disability (coverage varies by state)
- Long Term Disability
- Critical Illness, Hospital coverage, Accident Insurance
- MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
- 401(k)
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.