Senior Quality Engineer - Process Development
$87k - $149kMiniMed Group
- # Senior Quality Engineer - Process DevelopmentApplyremote type: On-Sitelocations: Northridge, California, United States of America: San Diego, California, United States of Americatime type: Full timeposted on: Posted Todaytime left to apply: End Date: July 10, 2026 (7 days left to apply)job requisition id: R-801145We anticipate the application window for this opening will close on - 10 Jul 2026At 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****Responsibilities may include the following and other duties may be assigned.****Process Development & Validation*** Develop P-diagrams, Input-Process-Output (IPO) matrices, process characterizations, and test method validation (TMV) strategies for NPI programs.* Author and manage Master Validation documents (IQ/OQ/PQ/EQV/TMV) for new product introductions and production scale-up.* Apply methodologies including Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Manufacturing Assembly (DFMA), and Cell Operating System (COS).* Drive risk mitigation approaches by integrating qualification parts early in process development phases**Process Risk Management & Risk Navigation*** Facilitate and generate Process Failure Modes Effects Analysis (PFMEA) documents for manufacturing processes during NPI and scale-up.* Maintain strong working knowledge of design risk documentation (RAD, DFMEA, HRA) to critically analyze process-related failures and identify gaps.* Recognize when process findings have design risk implications and escalate appropriately to Design Quality Assurance (DQA) partners for design risk assessment decisions.* Leverage understanding of risk documentation during root cause investigations and critical analyses to ensure comprehensive disposition.* Conduct thorough root cause investigations using A3 Problem Solving methodology, fishbone diagrams, 5-Why analysis, and brainstorming techniques**Cross-Functional Engagement & Collaboration*** Serve as the primary quality interface between internal Supplier Quality Engineering (SQE), R&D cross-functional teams, Contract Manufacturers, and NPI program teams* Facilitate regular cadence of alignment discussions with Supplier Quality and vendors to implement updated control plans, inspection criteria, and risk documentation.* Collaborate with R&D teams to translate design intent into manufacturable process parameters during design transfer* Partner with NPI groups to ensure seamless transition from development builds through production qualification and commercial readiness.* Ensure alignment between contract manufacturers and internal teams on deliverables, expectations, and quality standards.* Bridge QMS gaps between contract manufacturing partners and internal quality systems, standardizing documentation templates and expectations.* Direct comprehensive drawing reviews with cross-functional partners ensuring all Critical Dimensions are accounted for incoming and in-process inspections.**Production Scale-Up Support & Crisis Management*** Lead cross-functional teams through high-pressure production holds and scale-up challenges during NPI commercialization.* Conduct root cause investigations (A3 methodology) and implement Corrective and Preventive Actions (CAPA).* Strategize and guide engineering teams to deploy effective investigation approaches for supplier and manufacturing issues.* Proactively identify production risks during scale-up and drive containment/resolution before they impact launch timelines.**Statistical Analysis & Data-Driven Decision Making*** Perform statistical analyses including hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, and GR&R using Minitab.* Utilize statistical process control (SPC), I-MR charts, Box plots, and Normality & Non-Normal tests to make quality decisions.* Leverage data-driven approaches to inform process development decisions and validate process characterizations.* Generate process capability reports to support production readiness decisions**Must Have: Minimum Requirements*****To be considered for this role, please ensure the minimum requirements are evident on your resume.**** Bachelor’s degree with 4+ years’ relevant experience, or Advanced degree with 2+ years of experience.#BetterDaysStartNow# **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):$87,000.00 - $149,000.00For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $97,000 - $165,000 USD.Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).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.
- J-18808-Ljbffr MiniMed Group
Vacancy posted 3 days ago
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