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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.
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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
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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).
