Sr Quality Engineer

MiniMed•Los Angeles, CA

7d•$94,400 - $141,600•Hybrid

About The Position

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. 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. This role requires you to work on-site at our Northridge, CA at least 3 days per week.

Requirements

Bachelor’s degree in Engineering, Science or a related discipline.
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.
Minimum of 2 years of experience leading risk management activities across the product lifecycle

Nice To Haves

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

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