Sr Quality Engineer
il y a 10 jours
Los Angeles
We anticipate the application window for this opening will close on - 3 Apr 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 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 MiniMed offers a competitive salary and flexible benefits package At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. Salary ranges for U.S (excl. PR) locations (USD):$94,400.00 - $141,600.00 This position is eligible for a short-term incentive called the Short Term Incentive (STI). At MiniMed, we are committed to supporting the well-being and financial security of our employees. Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insurance, as well as access to a Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability leave, and a dependent daycare spending account. In addition, all regular employees enjoy incentive plans, a 401(k) plan with company match, short-term disability coverage, paid time off and holidays, participation in our Employee Stock Purchase Plan, and access to our Employee Assistance Program. Eligible employees may also benefit from our Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements. Please note that "regular employees" refers to those who are not temporary staff, such as interns, and some benefits may not apply to employees in Puerto Rico. For further details about our comprehensive benefits, we encourage you to visit the link below. MiniMed Benefits () Overview 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. Learn more about our business, and our mission here () . It is the policy of MiniMed to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, familial status, membership or activity in a local human rights commission, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law. In addition, MiniMed will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for MiniMed in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here () a list of all material job duties of the specific job position which MiniMed reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. MiniMed will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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