Sr Quality Engineer (New Product Development)

USA-MiniMed Distribution Corp. 1018; Los Angeles (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

MiniMed is seeking a Senior Quality Engineer to lead design quality activities for diabetes management devices, ensuring compliance with FDA QSR, ISO 13485, and MDSAP. On-site in Northridge, CA, at least 3 days per week, supporting design verification, validation, risk management, and manufacturing transfer throughout the product lifecycle.

Qualifications

• Minimum 4 years in a Design Quality role within a regulated medical device environment.
• Bachelor's degree in engineering, science, or related discipline.
• Experience leading risk management across the product lifecycle.

Responsibilities

• Lead system-level Design Assurance and Design Control activities for diabetes products across new development and sustaining design changes.
• Define, risk-based, traceable requirements across hardware, firmware, mobile apps, and cloud components.
• Review and approve system-level design outputs for safety, usability, cybersecurity, interoperability and performance.
• Support system-level V&V plans, protocols, and reports.
• Lead risk management, FMEAs and CAPA activities; manage defect investigations.

Skills

Quality engineering

Regulatory knowledge

Risk management

Root cause analysis

Communication skills

Education

B.S. in Engineering/Science

Tools

Minitab

Job description

We anticipate the application window for this opening will close on - 29 Oct 2026

At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You’ll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

About the Role

We are seeking a highly motivated and detail-oriented S enior 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. This role requires you to work on-site at our Northridge, CA at least 3 days per week.

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


• Ensure risks related to hardware, software, mobile apps, usability, cybersecurity, connectivity, and interoperability are identified, mitigated and verified per ISO 14971 requirements and applicable standards (IEC 60601, IEC 62366)


• 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


• Review, support, and approve design transfer activities to ensure design requirements are effectively transferred to manufacturing, including IQ, OQ, PQ, process validation, and inspection plans.


• Lead root cause analysis and CAPA activities using structured problem‑solving methodologies


• Assist in Internal Audits, Notified Body Audits and Regulatory Inspections

Must Have: Minimum 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

Nice to have

• 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 working knowledge of FDA QSR, ISO 13485, ISO 14971, and statistical techniques


• 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

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: 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