Stability Program Manager

Medtronic plc; Galway; On-site; EUR 84,880 - 127,320; Full time

Job summary

Medtronic plc in Galway, Ireland, is seeking a Stability Program Manager to lead the drug-device stability portfolio within ICT and PVH. You will own stability strategy, study design, and cross‑functional delivery across development, sustaining programs and manufacturing changes.

You will act as the stability SME, partner with Regulatory Affairs on submissions, audits, and inspections, and mentor the stability team.

Qualifications

• Bachelor’s degree (Level 8) with ≥5 years in drug stability or quality engineering.
• Experience in regulated medical devices or pharmaceuticals.
• Ability to lead complex technical workstreams and influence stakeholders.
• Experience with design controls, change control and risk management.

Responsibilities

• Lead stability program activities across ICT and PVH products.
• Define and execute stability strategies for new and mature programs.
• Serve as SME for drug stability across cross‑functional teams.
• Support regulatory submissions, audits and inspections.
• Collaborate with R&D, Manufacturing, Regulatory, and Quality partners.
• Mentor stability engineers and drive process improvements.

Skills

Quality engineering

Drug stability

Cross-functional leadership

Regulatory submissions

Problem solving

Mentoring

Education

Bachelor's degree (Level 8)

Job description

Stability Program ManagerSkip to main contentWe use necessary and audience measurement cookies to make this site work and produce anonymous statistics. We'd also like to set cookies and similar technologies to improve the functionality of the site, further analyze visitors' activity, and show personalized ads. These will be set only if you accept them. You can change your mind at any time by clicking on the "Cookie" icon at the bottom left of each page. To learn more on the cookies, we use and the third parties that are setting cookies on our site, click "Cookie preferences." Cookie policy#Stability Program Manager page is loaded## Stability Program ManagerApplyremote type: Flexible Work Arrangementlocations: Galway, County Galway, Irelandtime type: Full timeposted on: Posted Todaytime left to apply: End Date: August 4, 2026 (7 days left to apply)job requisition id: R72691Careers 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 [e-mail].# **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).