Senior Product Compliance Engineer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Come join us in developing innovative bioproduction solutions that enable our customers to bring life-saving therapies to market.

The role supports Thermo Fisher Scientific's Bioproduction Group (BPG) and primarily focuses on the Bioprocessing Equipment and Automation Business Unit (BEA). Manufacturing operations are located in Santa Clara, CA, and Logan, UT. The main responsibility is leading the product safety and compliance team in BPG's newly formed Regulatory Affairs organization to ensure products meet all safety standards required for sale in the global market.

The successful applicant needs to be an expert in product safety. They should have the ability to lead across different departments in a matrixed organization. Additionally, they will work closely with customers, regulators, and internal business partners.

Location: The role is based on-site in Santa Clara, California.

Travel: Approximately 10%, primarily in the Southern Bay Area to support product testing at third-party safety and EMC labs. Occasional travel (<5%) to suppliers, contract manufacturers, and other Thermo Fisher facilities.

Required Education:

• Bachelor's of Science in Electrical Engineering, Systems Engineering, Industrial Engineering, or a related field.

Required Experience:

• 10 years of experience in Product Compliance, Product Safety, Electromagnetic Compatibility, NRTL and CE Marking, and other Global Market Entry initiatives.

Responsibilities:

• Manage the NRTL and CE Testing and Certification Process for a portfolio of capital equipment used to produce groundbreaking bio-pharmaceuticals.
• Collaborate with Quality and Engineering organizations to manage product configurations to ensure all products brought to market are supported by objective evidence of compliance.
• Prepare and deliver product compliance training for Engineers, Product and Project managers, R&D, Supply Chain, and other business partners.
• Benchmark across other groups within Thermo Fisher to assess the effectiveness and efficiency of Compliance policies and procedures. Collaborate with Practical Process Improvement (PPI) teams to implement enhancements.
• Develop processes to govern regulatory requirements related to user documentation and labeling.
• Work hand in hand with engineers and technicians to train and troubleshoot safety and EMC issues at on-site and third party laboratories.

Knowledge and Skills:

• Deep understanding of IEC/EN product standards, including IEC 61010-1, IEC 60204-1, IEC 61326, CISPR and similar in-country standards.
• Detailed comprehension of the Low Voltage Directive, Machinery Directive/Regulation, Electromagnetic Compatibility Directive.
• Comfortable training and leading diverse teams in Risk and Hazard Analysis methodologies, including ISO 12100 and ISO 14971.
• Basic understanding of Functional Safety, Radio Equipment Directive, Software Safety Validation.
• Solid knowledge of Environmental Material Compliance initiatives, including REACH, RoHS, California Prop 65, and PFAS regulations.

Compensation and Benefits

The salary range estimated for this position based in California is $112,500.00–$168,750.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards