We anticipate the application window for this opening will close on - 3 Apr 2026
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. This role requires you to work on-site at our Northridge, CA at least 3 days per week.
Responsibilities may include the following and other duties may be assigned
- 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
- 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 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 communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & Compensation
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