Manager, Compliance Engineering

Tandem Diabetes Care; California (MO); Hybrid; USD 142,000 - 177,000; Full time

Benefits offered by this job

Health insurance

HSA

Flexible savings accounts

Paid holidays

Paid time off

401k with company match

Employee stock purchase plan

Job summary

Tandem Diabetes Care in Del Mar, CA is seeking a Manager, Compliance Engineering to lead testing and certification activities for medical devices. You will develop strategies, manage external labs, and ensure safety, EMC, and regulatory compliance from development through commercialization.

You’ll mentor a team of engineers, manage budgets, and drive continuous improvement in testing processes while aligning with FDA QSR/QMSR, ISO 14971, and IEC 60601 standards. Hybrid work offered.

Qualifications

• Bachelor’s degree or higher in a relevant engineering field with appropriate job experience.
• Strong knowledge of medical device safety and regulatory standards.
• Experience managing external compliance testing labs and certification programs.
• Proven ability to lead teams and manage multiple testing programs.

Responsibilities

• Lead compliance testing and certification activities for new products and modifications.
• Develop strategies, plans, schedules, and resources for product development programs.
• Oversee testing related to safety, EMC, wireless, and regulatory requirements.
• Manage relationships with external labs and certification bodies to meet objectives.
• Review test plans, reports, and risk assessments and drive mitigation strategies.

Skills

Compliance testing

Regulatory engineering

Product certification

Leadership

Project management

Risk management

FDA QSR/QMSR

ISO 14971

IEC 60601

External labs management

Education

Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering or related technical discipline

Master’s degree desirable

Job description

GROW WITH US:

Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry.

STAY AWESOME:

Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology — an advanced predictive algorithm that automates insulin delivery. But we’re so much more than that. Our company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com

A DAY IN THE LIFE:

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.

WHAT YOU’LL NEED:

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering or related technical discipline, or equivalent combination of education and applicable job experience.
• Advanced coursework, Master’s degree, or professional licensing in related field desirable.
• 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.

WHEN & WHERE YOU’LL WORK:

Hybrid : This role will be a mix of in-office work at our corporate headquarters in Del Mar, CA and remote work. This position is expected to be in office 3+ days per week but may vary depending on business demands.

COMPENSATION & BENEFITS:

The starting base pay range for this position is $141,800.00 - $177,300.00 annually. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate’s location and the overall job market. In addition to base pay, Tandem offers a competitive compensation package that includes bonus and a robust benefits package.

• health care benefits such as medical, dental, vision available your first day
• health savings accounts
• flexible saving accounts
• 11 paid holidays per year
• a minimum of 20 days of paid time off (with accrual starting on day 1)
• 401k plan with company match
• Employee Stock Purchase plan

YOU SHOULD KNOW:

Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information.

Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders.

SPONSORSHIP:

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

WHY YOU’LL LOVE WORKING HERE:

At Tandem, we believe joy fuels excellence. That’s why we’ve built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at https://www.tandemdiabetes.com/careers.

BE YOU, WITH US!

We embrace the value that every single one of us brings to the table. But sometimes we forget that when we don’t meet 100% of a job description’s criteria – maybe you’re feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us.

Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation. We are an inclusive organization, and we welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone.

REFERRALS:

We love a good referral! If you know someone who would be a great fit for this position, please share!

APPLICATION DEADLINE:

The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.

Make a move that matters. Join Tandem Diabetes Care, where we’re turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow.