Manager, Compliance Engineering
Tandem Diabetes Care
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Benefits offered by this job
Job summary
Tandem Diabetes Care seeks a Manager, Compliance Engineering to lead testing and certification for a portfolio of medical devices. You will develop strategies, manage external labs, and work with Engineering, Quality, and Regulatory Affairs to ensure safety and regulatory compliance through development to commercialization.
The role requires strong leadership, regulatory knowledge (FDA QSR/QMSR, ISO 14971, IEC 60601), and a track record of cross-functional collaboration in a high-volume setting.
Qualifications
- Bachelor’s degree in a technical field and strong knowledge of medical device testing.
- Master’s degree or professional licensing is desirable.
- 5-8+ years of experience leading compliance testing in medical devices.
Responsibilities
- Lead compliance testing and certification activities for new products and 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 regulatory requirements.
- Manage relationships with external test laboratories, certification bodies, and consultants.
- Review and approve test plans, protocols, reports, risk assessments, and certification documentation.
- Partner with Engineering teams to identify compliance risks early and drive mitigation.
- Support design reviews and risk management activities with a focus on safety and regulatory compliance.
- Monitor changes in regulatory requirements and industry standards, and update testing strategies accordingly.
- Develop and improve compliance testing processes, tools, metrics, and best practices.
- Lead, mentor, and develop a team of compliance engineers and test professionals.
Skills
Education
Tools
Job description
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.
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
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.
- 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.
- 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.
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.
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.
- Tandem offers health care benefits such as medical, dental, vision available your first day, as well as health savings accounts and flexible saving accounts.
- You’ll also receive 11 paid holidays per year.
- A minimum of 20 days of paid time off (with accrual starting on day 1).
- Access to a 401k plan with company match.
- Employee Stock Purchase plan.
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.
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.
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.
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.
We love a good referral! If you know someone who would be a great fit for this position, please share!
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.
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