Manager, Compliance Engineering (Medical Devices)

TL;DR

Manager, Compliance Engineering (Medical Devices): Leading compliance testing and certification for connected medical devices with an accent on safety, EMC, wireless, environmental, and regulatory requirements. Focus on designing test strategies, managing certification programs, mitigating product risks, and developing technical teams through commercialization.

Location: Hybrid role based at the corporate headquarters in Del Mar, California, with at least 3 days per week in the office and remote work on other days. Applicants must be authorized to work for any employer in the United States; visa sponsorship is not available.

Salary: $141,800–$177,300 annually, plus bonus and benefits.

Company

hirify.global develops and manufactures insulin-delivery products, including the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology.

What you will do

• Lead compliance testing and product certification for new products and product modifications.
• Develop testing strategies, plans, schedules, resources, and risk-mitigation approaches.
• Oversee safety, EMC, wireless, environmental, and other regulatory testing.
• Manage external laboratories, certification bodies, consultants, budgets, and delivery objectives.
• Review test plans, protocols, reports, risk assessments, and certification documentation.
• Lead and develop compliance engineers and test professionals while improving processes, tools, metrics, and best practices.

Requirements

• Bachelor’s degree in mechanical, electrical, biomedical engineering, or a related technical discipline, or equivalent experience.
• 5–8+ years of experience leading compliance testing, product certification, or regulatory engineering in the medical device industry.
• Strong knowledge of FDA QSR/QMSR, ISO 14971, and IEC 60601 requirements.
• Experience with EMC, electrical safety, wireless, software/firmware compliance, risk management, quality systems, GDP, and GMP.
• Proven ability to lead technical teams, manage external testing laboratories, and run multiple programs simultaneously.
• Strong project management, communication, stakeholder management, and process improvement skills.

Nice to have

• Master’s degree, advanced coursework, or professional licensing in a related field.
• Leadership experience in a high-volume medical device, biotech, or pharmaceutical environment.

Culture & Benefits

• Hybrid work with regular collaboration at the corporate headquarters.
• Medical, dental, and vision coverage available from the first day.
• Health savings and flexible spending accounts.
• At least 20 days of paid time off and 11 paid holidays annually.
• 401(k) with company match and an Employee Stock Purchase Plan.
• Pre-employment drug testing and background screening are required.