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 Medtronic At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. Our Purpose Interventional Cardiology Therapies is a vital component of the Medtronic Cardiovascular portfolio, consisting of coronary, renal denervation and structural heart therapies. In ICT, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re are seeking a Quality Engineering Program Manager to lead the drug stability portfolio for the ICT and PVH drug-device combination products. This highly visible technical leadership role will own and drive the stability strategy, execution, regulatory support and cross-functional alignment across new product development, sustaining projects, design changes, manufacturing changes and audit readiness. You will serve as a key subject matter expert (SME) for stability matters, partnering with cross functional stakeholders and project teams to ensure stability strategies and deliverables are robust, compliant and aligned with business priorities. You will help protect continuity of a critical capability, support ongoing project delivery, and ensure stability requirements are effectively integrated across the product lifecycle. Come for a job, stay for a career! A Day in The Life Of:
Responsibilities
may include the following and other duties may be assigned. Lead stability program activities for all drug device combinations products across ICT and PVH, ensuring stability deliverables are planned, executed and maintained in alignment with project milestones, regulatory expectations and business needs. Define and execute stability strategies for new product development projects, sustaining programs, design changes, manufacturing changes, supplier changes and product lifecycle activities. Serve as the primary Quality technical expert for drug stability, providing guidance to cross-functional teams on stability requirements, study design, protocols, data interpretation, reporting and change impact assessments. Partner with Regulatory Affairs to support regulatory submissions, responses to questions, audits and inspections related to stability strategy, data and commitments. Create, review and approve stability protocols, reports, justifications and technical documentation to ensure compliance with internal procedures, design controls and applicable regulatory requirements. Maintain integrated stability plans, schedules, dependencies and risk assessments to ensure testing, data compilation, reporting and decision-making are completed on time. Support PDP, RPM and sustaining project teams by identifying stability risks, assessing impact to timelines and deliverables, and driving timely resolution through technical leadership and influence. Provide audit and inspection support as the Stability SME, ensuring clear rationale, traceability and compliance readiness for stability decisions and documentation. Collaborate with R&D, Manufacturing, Operations, Analytical Labs, Regulatory Affairs, Clinical, Supply Chain and Quality partners to align stability activities across complex drug/device programs. Exhibit strong problem-solving skills, and support test investigations as needed Mentor and develop stability team members, strengthening organizational capability, technical depth and succession readiness within the stability function. Drive continuous improvement in stability processes, planning practices, documentation quality and cross-functional ways of working. Communicate stability priorities, project status, risks, mitigation plans and key decisions clearly to Quality leadership, project teams and senior stakeholders. Required Knowledge and
Experience
Requires a bachelor's degree (Level 8) with a minimum of 5 years of relevant experience or advanced degree with a minimum of 3 years of experience. Demonstrates advanced expertise in drug stability, Quality engineering or a related technical discipline, with broad and in-depth knowledge typically gained through a combination of higher education and relevant experience. Strong understanding of drug stability principles, stability study design, data analysis, protocols, reports and regulatory expectations for drug/device or combination products.
Experience
supporting product development, sustaining engineering, design changes, manufacturing changes, regulatory submissions, audits and inspections in a regulated medical device, pharmaceutical or combination product environment. Proven ability to operate as a technical Subject Matter Expert, providing clear guidance, rationale and decision support to project teams and senior stakeholders. Demonstrated experience leading complex technical workstreams across multiple programs, including planning deliverables, managing dependencies, identifying risks and driving execution. Strong knowledge of Quality systems, Design Controls, change control, risk management and applicable global regulatory requirements. Excellent cross-functional leadership skills, with the ability to lead through influence, build credibility quickly and collaborate effectively in a matrixed environment. Strong communication skills, including the ability to translate complex technical stability topics into clear messages for leadership, project teams, auditors and regulatory partners. Ability to manage competing priorities, make sound technical judgments and drive timely issue resolution while maintaining quality and compliance standards. Demonstrated commitment to mentoring, knowledge transfer and building sustainable technical capability within the organization. Nice to Have Knowledge and
Experience
Experience
with coronary, peripheral vascular or other cardiovascular drug-device combination products.
Experience
working across multiple operating units, geographies manufacturing sites.
Experience
preparing and defending stability strategies during regulatory audits, notified body reviews or health authority interactions. Knowledge of analytical testing, laboratory operations, sample management and stability storage requirements. Prior experience coaching or developing stability engineers, technicians or cross-functional partners. Medtronic offer a competitive salary and flexible
Benefits
Package #LI-Hybrid 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. Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com.
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. Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 84,880.00 EUR - 127,320.00 EUR | This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). 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. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care 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. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com