Senior Compliance Engineer at Johnson & Johnson

Santa Clara, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

MedTech, Healthcare, Medical DevicesIndustries

Requirements

Bachelor's degree in Electrical Engineering, Electronics, or a related discipline
5+ years of experience in EMC and electrical safety compliance for medical devices

Responsibilities

Lead EMC and electrical safety compliance programs for medical products, ensuring conformity to IEC 60601-1, IEC 60601-1-2, relevant collateral and particular standards, and regional adaptations (EN/UL/CE/CSA 60601 series)
Partner with R&D, Systems, and Quality teams to define design-for-compliance strategies early in the product lifecycle
Develop and maintain EMC and safety test plans, including pre-compliance and final certification testing
Conduct or oversee pre-compliance evaluations, troubleshoot failures, and recommend EMC mitigation and safety design improvements
Serve as the primary technical contact for Notified Bodies, NRTLs, and accredited test laboratories (TÜV, UL, Intertek, BSI etc.)
Manage certification schedules, quotes, and deliverables for assigned products
Review and approve schematics, PCB layouts, enclosure designs, and grounding/shielding strategies for compliance
Ensure complete and accurate technical documentation (test reports, risk analyses, Declarations of Conformity, etc.) is maintained in compliance with ISO 13485 and ISO 14971 processes
Stay current with global regulatory changes (EU MDR, FDA, China NMPA, etc.) impacting EMC and safety compliance and communicate updates to internal stakeholders
Support regulatory submissions and audits by providing technical input and documentation evidence

Skills

EMC

IEC 60601

Product Safety

Electrical Engineering

Electronic Medical Devices

Mechatronic Engineering

Robotics

R&D

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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