Sr Quality Engineer

About the role

We are seeking a highly motivated and detail-oriented Senior Hardware Design Quality Engineer to lead and implement Design Quality Engineering activities for diabetes management products, including insulin pumps, continuous glucose monitoring (CGM) systems, and closed-loop / automated insulin delivery systems. In this role, you will ensure that product designs comply with FDA regulations, ISO 13485, applicable global regulatory standards, and internal company procedures. You will serve as a key quality partner throughout the product development lifecycle, providing design quality leadership from concept through commercialization.

Responsibilities

• Lead system-level Design Assurance and Design Control activities for diabetes products across new development and sustaining design changes, ensuring compliance with FDA QSR, ISO 13485, MDSAP, and global regulatory requirements
• Ensure system, subsystem, and software requirements are clearly defined, risk-based, traceable, and verified across hardware, firmware, mobile apps, and cloud components
• Review and approve system-level design outputs to ensure safety, usability, cybersecurity, interoperability, and performance requirements are met
• Support the development, review, and execution of system-level Verification & Validation (V&V) plans, protocols, and reports
• Ensure comprehensive test coverage across hardware, embedded software, mobile applications, algorithms, and cloud components
• Review and approve test methods validation, test procedures, statistical analysis approaches, and acceptance criteria
• Lead Risk Management process for assigned products, facilitating development and implementation of risk management plans, risk management reports, FMEAs, and integrated system risk assessments
• Identify and document CTQ parameters based on risk assessment results and ensure effective controls are implemented
• Lead defect investigation and resolution for defects identified during design verification and from field reports, using risk-based decision making and the defect tracking process
• Lead root cause analysis and CAPA activities using structured problem-solving methodologies
• Assist in Internal Audits, Notified Body Audits and Regulatory Inspections

Requirements

• Minimum of 4 years of experience, or an advanced degree with at least 2 years of experience, in a Design Quality role within a regulated medical device environment
• Bachelor’s degree in engineering, Science or a related discipline
• Minimum of 2 years of experience leading risk management activities across the product lifecycle

Qualifications

• ASQ Certified Quality Engineer (CQE)
• Experience with Software as a Medical Device (SaMD) or electromechanical systems (specifically IEC 62304)
• Prior experience in the Diabetes or Infusion Pump industry
• Proficiency in statistical software such as Minitab for trend analysis and data-driven assessments
• Six Sigma Green or Black Belt certification
• Strong verbal and written communication skills, with the ability to facilitate cross-functional risk and defect discussions
• Strong organizational skills, including the ability to multitask, prioritize, follow up, and meet deadlines with attention to detail

Skills

• Strong working knowledge of FDA QSR, ISO 13485, ISO 14971, and statistical techniques
• Physical Job Requirements: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers.

Benefits & Compensation

At MiniMed, we offer a competitive salary and flexible benefits package. Benefits and compensation information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

About MiniMed

MiniMed is a full-stack insulin delivery company dedicated to supporting people living with diabetes through every step of their journey — when and how they need it. For more than 40 years, we’ve been committed to redefining what’s possible: intelligent dosing systems designed for real life, predictive insights that stay a step ahead, and always on support when it’s needed most. At the heart of everything we do is a simple Mission: to make every day a better day for people with diabetes.