Principal Quality Engineer - Process Development
About The Position
The Principal Quality Engineer will oversee quality records and strategy for low- to mid-volume manufacturing lines and new product scale-up across multiple product platforms. The role requires professional discretion to ensure teams follow standard operating procedures while taking a pragmatic, collaborative approach. The engineer will act as a trusted cross-functional partner and influencer, helping remove obstacles and build alignment. The position focuses on process development and validation, process risk management, cross-functional collaboration, and statistical analysis. The engineer develops process characterization and validation strategies, manages validation documentation, facilitates risk assessments and investigations, and supports design transfer, production qualification, and commercialization. The role also uses statistical methods and data to guide process decisions and determine production readiness. MiniMed is an insulin delivery company focused on supporting people living with diabetes. The company describes its mission as making every day a better day for people with diabetes and states that it provides equal employment opportunity and reasonable accommodations for qualified individuals with disabilities.
Requirements
- Master's degree in Mechanical Engineering, Biomedical Engineering, or a related field and at least 5 years of experience in process development or manufacturing engineering for medical devices; alternatively, a bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering field and at least 7 years of such experience.
- Strong working knowledge of statistical methods, including DOEs, capability studies, and Gage R&R, used in manufacturing.
- Working knowledge of FDA QSR (21 CFR Part 820) and ISO 13485.
- Experience exercising professional discretion, influencing cross-functional peers, and guiding technical root cause investigations.
- While performing office duties, the employee is regularly required to be independently mobile, interact with a computer, and communicate with peers and co-workers.
Nice To Haves
- At least 7 years creating or overseeing complex IQ/OQ/PQ and TMV strategies for medical devices.
- Mastery of ISO 14971 and pFMEA, with a track record of linking process risks to design controls.
- Experience supporting low- to mid-volume electromechanical production lines or wearable medical devices.
- CQE (Certified Quality Engineer) or Six Sigma Black Belt certification.
Responsibilities
- Develop P-diagrams, Input-Process-Output matrices, process characterizations, and test method validation strategies for NPI programs.
- Author and manage Master Validation documents (IQ/OQ/PQ/EQV/TMV) for new product introductions and production scale-up.
- Apply Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Manufacturing Assembly (DFMA), and Cell Operating System (COS) methodologies.
- Integrate qualification parts early in process development to mitigate risk.
- Facilitate and generate process Failure Modes Effects Analysis (pFMEA) documents for manufacturing processes during NPI and scale-up.
- Use design risk documentation (RAD and dFMEA) to analyze process-related failures and identify gaps.
- Recognize process findings with design risk implications and escalate them to Design Quality Assurance partners for design risk assessment decisions.
- Use risk documentation during root cause investigations and critical analyses to support comprehensive disposition.
- Conduct root cause investigations using A3 Problem Solving, fishbone diagrams, 5-Why analysis, and brainstorming.
- Align 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 transition from development builds through production qualification and commercial readiness.
- Lead cross-functional drawing reviews to ensure Critical Dimensions are accounted for in incoming and in-process inspections.
- Lead cross-functional teams through production holds and scale-up challenges during NPI commercialization.
- Guide engineering teams in selecting investigation approaches for supplier and manufacturing issues.
- Identify production risks during scale-up and drive containment and resolution before launch timelines are affected.
- Perform statistical analyses, including hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, and GR&R using Minitab.
- Use SPC, I-MR charts, box plots, and normality and non-normality tests to make quality decisions.
- Use data-driven approaches to inform process development decisions and validate process characterizations.
- Generate process capability reports to support production readiness decisions.
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Incentive plans
- 401(k) plan with company match
- Short-term disability coverage
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (eligible employees, subject to IRS minimum earnings requirements)
- Capital Accumulation Plan (eligible employees, subject to IRS minimum earnings requirements)
- Flexible benefits package
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What This Job Offers
Job Type
Full-time
Career Level
Principal
