Sr Quality Engineer-New Product Introduction

Medtronic; Juncos (PR); On-site; USD 90,000 - 150,000; Full time

Job summary

Medtronic in the United States is seeking a Senior Quality Engineer to lead quality initiatives for new product introductions in a regulated manufacturing environment.

You will partner with engineering and manufacturing to drive risk management, validation, change control, and continuous improvement across the product lifecycle.

Qualifications

• Bachelor's degree in engineering or advanced degree with industry experience.
• Experience in a regulated medical device environment is preferred.
• Strong knowledge of quality tools and methods for investigations and improvements.
• Ability to collaborate with engineering, manufacturing, and quality teams.

Responsibilities

• Lead quality initiatives to improve product quality and process performance.
• Develop and maintain quality standards for materials, components, and finished products.
• Partner with engineering and manufacturing to embed quality into processes.
• Design inspection and testing methods to verify product quality and reliability.
• Analyze quality data, identify trends, and enable data-driven decisions.
• Investigate nonconformances and ensure corrective actions are completed.

Skills

Quality leadership

Risk management

Statistical analysis

Cross-functional collaboration

Education

Bachelor's Degree in Engineering

Master's Degree in Engineering or related field

PhD

Tools

Minitab

SPC

Job description

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life.

Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

The Senior Quality Engineer provides quality leadership and oversight for new product introduction activities, ensuring products and manufacturing processes meet regulatory, quality, and business requirements. This role partners with cross‑functional teams to drive risk management, design and process validation, change control, and product transfer activities from development through commercial launch, while supporting continuous improvement and risk burndown initiatives at the site. This role also provides oversight to equipment and process validation activities at the site. The Senior Quality Engineer is responsible for supporting product and process quality within a regulated manufacturing environment. This role collaborates across functions to establish quality standards, lead quality improvement initiatives, analyze quality data, and ensure compliance with applicable regulations and quality system requirements while driving continuous improvement and operational excellence.

Primary Responsibilities

• Lead and support continuous improvement projects and quality initiatives that enhance product quality, process performance, and compliance.
• Develop, implement, maintain, and improve quality standards and protocols for materials, components, and finished products.
• Partner with engineering and manufacturing teams to ensure quality requirements are effectively integrated into manufacturing processes and operations.
• Design and implement inspection, testing, and evaluation methods to verify product quality, equipment performance, and process effectiveness.
• Conduct statistical analysis and quality assurance activities to evaluate product and process performance, identify trends, and support data‑driven decision making.
• Investigate nonconforming products or materials, determine root causes, and ensure appropriate corrective actions are implemented and documented.
• Ensure quality documentation, corrective actions, and quality system activities comply with applicable regulatory and internal requirements.
• Provide technical quality support across design, incoming materials, production control, product evaluation, reliability, inventory control, research and development, or other quality-related areas as needed.

Required Qualifications

• Bachelor's Degree in Engineering and a minimum of 4 years of relevant experience; OR Master's Degree and a minimum of 2 years of relevant experience; OR PhD.
• Experience supporting quality engineering activities within a regulated manufacturing or medical device environment.
• Experience applying quality tools and methodologies to support investigations, corrective actions, and process improvements.
• Experience collaborating with cross‑functional teams including engineering, manufacturing, and quality organizations.

Preferred Qualifications

• Experience with Design Controls, Risk Management, and quality engineering activities throughout the product lifecycle.
• Experience leading cross‑functional projects and influencing stakeholders in a matrixed environment.
• Expertise with statistical analysis tools including Minitab, Statistical Process Control (SPC), and trend analysis.
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience with validation lifecycle management, change control, quality risk management, reliability engineering, product performance testing, and mentoring engineers or project teams.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R.

• 214.2(h)(4)(iii)(A) is required.

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.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise‑wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long‑term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP).

Medtronic Benefits And Compensation Plans

It is the policy of Medtronic 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, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) 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 Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic 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.