Manager, Compliance Engineering

Tandem Diabetes Care•California - High Bluff, CA

2d•$141,800 - $177,300•Hybrid

About The Position

We are seeking a Manager, Compliance Engineering to lead compliance testing activities for a portfolio of innovative medical devices. This role is responsible for developing and executing compliance test strategies, managing product certification efforts, and ensuring products meet applicable safety, EMC, wireless, and regulatory requirements. As a key technical leader, you will work closely with Engineering, Quality, Regulatory Affairs, and external test laboratories to guide products from development through certification and commercialization. The ideal candidate combines strong technical expertise in medical device testing with the ability to lead teams, manage complex projects, and drive continuous improvement. The Manager, Compliance Engineering Drives Product Compliance Through Testing Excellence and is also responsible for; Lead compliance testing and certification activities for new products and product modifications. Develop compliance test strategies, plans, schedules, and resource requirements for product development programs. Oversee product testing related to safety, EMC, wireless, environmental, and other applicable regulatory requirements. Manage relationships with external test laboratories, certification bodies, and consultants, ensuring quality, cost, and schedule objectives are achieved. Review and approve test plans, protocols, reports, risk assessments, and certification documentation. Partner with Engineering teams to identify compliance risks early and drive effective testing and mitigation strategies. Support design reviews and risk management activities with a focus on product safety, performance, and regulatory compliance. Monitor changes in regulatory requirements and industry standards, assess impacts, and implement testing strategies to maintain compliance. Develop and improve compliance testing processes, tools, metrics, and best practices to increase efficiency and predictability. Lead, mentor, and develop a team of compliance engineers and test professionals. Manage departmental budgets and forecasting related to compliance testing, laboratory services, equipment, and resources. Ensure all activities are conducted in accordance with company policies and applicable quality, regulatory, privacy, and safety requirements.

Requirements

Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering or related technical discipline, or equivalent combination of education and applicable job experience.
5-8+ years of experience leading compliance testing, product certification, or regulatory engineering activities within the medical device industry.
5+ years of experience leading/supervising in a high volume, medical device, biotech, or pharmaceutical environment preferred.
Strong knowledge of medical device safety and regulatory standards, including FDA QSR/QMSR, ISO 14971, and IEC 60601 series requirements.
Experience managing external compliance testing laboratories and certification programs.
Knowledge of EMC, electrical safety, wireless, and software/firmware compliance requirements for connected medical devices.
Proven ability to lead technical teams and manage multiple compliance testing programs simultaneously.
Experience with risk management, quality systems, GDP, and GMP requirements.
Strong project management, communication, and stakeholder management skills.
Demonstrated success driving process improvements and operational excellence within a testing or compliance organization.

Nice To Haves

Advanced coursework, Master’s degree, or professional licensing in related field desirable.

Responsibilities

Lead compliance testing and certification activities for new products and product modifications.
Develop compliance test strategies, plans, schedules, and resource requirements for product development programs.
Oversee product testing related to safety, EMC, wireless, environmental, and other applicable regulatory requirements.
Manage relationships with external test laboratories, certification bodies, and consultants, ensuring quality, cost, and schedule objectives are achieved.
Review and approve test plans, protocols, reports, risk assessments, and certification documentation.
Partner with Engineering teams to identify compliance risks early and drive effective testing and mitigation strategies.
Support design reviews and risk management activities with a focus on product safety, performance, and regulatory compliance.
Monitor changes in regulatory requirements and industry standards, assess impacts, and implement testing strategies to maintain compliance.
Develop and improve compliance testing processes, tools, metrics, and best practices to increase efficiency and predictability.
Lead, mentor, and develop a team of compliance engineers and test professionals.
Manage departmental budgets and forecasting related to compliance testing, laboratory services, equipment, and resources.
Ensure all activities are conducted in accordance with company policies and applicable quality, regulatory, privacy, and safety requirements.