Principal Quality Engineer

MiniMed

• $121K — $205K *
Hospitals & Medical Centers
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree with 7+ years' relevant experience, or advanced degree with 5+ years of experience.
  • Strong expertise in quality standards, protocols, and compliance in manufacturing.
  • Experience with statistical analysis tools such as Minitab or equivalent.
  • Proficient in corrective and preventive action (CAPA) methodologies and investigations.
  • Hands-on experience in risk management tools like FMEA and ISO 14971.

Responsibilities

  • Develops and maintains quality standards and protocols for product processing.
  • Collaborates with engineering and manufacturing to implement quality measures.
  • Implements testing and inspection methods to evaluate product precision and accuracy.
  • Designs testing mechanisms and conducts quality assurance tests.
  • Leads quality activities for new product introductions and validation processes.
  • Identifies and mitigates quality risks throughout the manufacturing process.
  • Maintains test method validations to ensure compliance with regulatory standards.

Benefits

  • Competitive salary and flexible benefits package.
  • Health, dental, and vision insurance offerings.
  • 401(k) plan with company match and employee stock purchase plan.
  • Paid time off and holidays to support work-life balance.
  • Access to an Employee Assistance Program for well-being support.
Full Job Description
We anticipate the application window for this opening will close on - 2 Oct 2026

About the Role

Are you a seasoned quality engineering professional with a passion for precision, compliance, and making a meaningful impact? We are looking for an experienced Quality Engineer to join our on-site manufacturing team at MiniMed, a leader in innovative diabetes management solutions.

In this critical role, you will serve as a cornerstone of our day-to-day manufacturing quality operations ensuring our products meet the highest standards of accuracy, reliability, and regulatory compliance.

You will play an integral part in the launch of next-generation medical device products, leading test method validations, driving risk mitigation strategies, and collaborating with cross-functional teams to bring life-changing technology to patients who depend on it. This is an opportunity to directly influence product integrity and patient outcomes in a fast-paced, highly regulated medical device environment. If you are a detail-oriented, proactive, and collaborative quality professional who thrives on solving complex challenges and delivering results, this role is for you.

Ready to make an impact? Apply now and join our team!
Responsibilities may include the following and other duties may be assigned.

On Site Role

  • Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
  • Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
  • Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
  • Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
  • Leads quality engineering activities in support of new product introduction (NPI), including design transfer, process validation, and launch readiness assessments, to ensure a smooth transition from development to full-scale manufacturing in compliance with regulatory and quality requirements.
  • Proactively identifies, evaluates, and mitigates quality risks across the manufacturing process utilizing risk management tools such as FMEA, Control Plans, and ISO 14971 frameworks to prevent quality escapes and minimize impact to production schedules and customer deliverables.
  • Develops, executes, and maintains test method validations (TMV) including method development, qualification, and revalidation activities to ensure measurement systems are accurate, reliable, and compliant with applicable regulatory standards and internal quality requirements.


Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

  • Bachelor's degree with 7+ years' relevant experience, or Advanced degree with 5+ years of experience.


Nice To Have:

  • Proficiency in statistical analysis tools such as Minitab or equivalent, with hands-on experience applying statistical process control (SPC), Design of Experiments (DOE), and data-driven problem-solving methodologies to drive quality improvements in a high-volume manufacturing setting.
  • Proven experience in Corrective and Preventive Action (CAPA) ownership, including the ability to lead end-to-end CAPA investigations, perform thorough root cause analyses using methodologies such as 8D, Fishbone, and 5-Why, and drive timely, sustainable corrective actions to closure in compliance with regulatory requirements.


#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):$109,000.00 - $185,000.00

For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $121,000 - $205,000 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

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