Quality Program Manager Visa Sponsorship Jobs in Massachusetts

INTRODUCTION

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Join Medtronic as a Senior Quality Program Manager – Quality Core Team Member (QCTM) and be at the forefront of transforming lives through advanced medical technology. In this highly visible role, you will serve as the Quality Core Team Member for complex cardiac electrophysiology programs, working in close partnership with R&D, Systems Engineering, Manufacturing, Regulatory, Clinical, and Operations to drive the successful development, transfer, and sustainment of Affera products.

By blending technical quality expertise, program leadership, and a deep commitment to patient safety, regulatory compliance, and design excellence, you will play a critical role in ensuring robust design execution and high‑quality product delivery as Affera technology continues to scale globally.

Primary Responsibilities

• Acts as the Quality Core Team Member (QCTM) and program‑level Quality lead for assigned product development programs, with accountability for quality strategy, execution, and outcomes across the full product lifecycle.

• Plans, directs, and oversees all Quality aspects of design and development, ensuring compliance with Medtronic policies, global regulatory requirements, and applicable quality system regulations.

• Leads and integrates Quality program planning, including design control strategy, design verification planning, risk management planning, design transfer readiness, and post‑market quality considerations.

• Provides Quality leadership for design verification and validation activities, including review and approval of test strategies, protocols, methods, execution readiness, and test results.

• Ensures robust test method development, qualification, and validation, partnering with engineering, manufacturing, and suppliers to establish reliable, reproducible, and compliant methods.

• Owns and drives product and process risk management activities, including hazard analysis, FMEAs, and risk/benefit assessments, ensuring alignment with system architecture, clinical intent, and real‑world use.

• Leads Quality oversight for design transfer, collaborating with manufacturing, supplier quality, operations, and regulatory partners to ensure product and process readiness for commercialization.

• Guides cross‑functional teams through phase gate reviews, design reviews, and key quality decision points, providing clear recommendations and risk‑based decision support.

• Monitors and ensures the integrity of design history file (DHF) documentation, traceability, and configuration management throughout the development lifecycle.

• Coordinates Quality activities with external suppliers, test labs, and consultants, ensuring timely delivery, compliance, and risk mitigation.

• Identifies gaps, risks, and improvement opportunities within Quality processes and program execution; drives corrective actions and continuous improvement initiatives.

• Is a mentor, leader, or direct manager to earlier career QCTMs.

• Other duties may be assigned.

Required Qualifications

• Bachelor's degree and a minimum of 7 years of relevant experience

• OR an advanced degree with a minimum of 5 years of relevant experience

Preferred Qualifications

• Experience working with Class III medical devices.

• Broad knowledge of Quality systems and product development, with mastery in at least one technical or professional discipline and working knowledge across adjacent functions.

• Proven experience leading cross‑functional, matrixed teams on complex product development programs.

• Strong understanding of design controls, design verification and validation, risk management, test methods, and design transfer.

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.

Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.

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.

Salary ranges for U.S (excl. PR) locations (USD): $168,800.00 - $253,200.00

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

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week:
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees:
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:
Medtronic benefits and compensation plans

ABOUT MEDTRONIC

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

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.