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Senior Project Manager, Global Device Engineering - Job Opportunity at Mallinckrodt

Dublin, Ireland
Full-time
Senior
Posted: August 15, 2025
On-site
EUR 85,000 - 120,000 per year. Dublin's position as a European pharmaceutical and medical device hub, combined with the senior-level requirements and specialized regulatory knowledge needed, places this role in the upper tier of project management compensation. The extensive FDA/510K experience requirements and people management responsibilities justify premium compensation levels.

Key Responsibilities

Lead strategic technical projects including new product development and sustaining engineering initiatives through cross-functional matrix organizations, directly impacting company's competitive positioning in medical device markets
Drive strategic alignment and execution of high-impact projects that define the Device Engineering group's contribution to organizational objectives and market leadership
Provide expert guidance on tactical projects while identifying and capitalizing on technological advances that position the company at the forefront of medical device innovation
Execute comprehensive project planning and management activities ensuring compliance with design controls and regulatory standards, directly affecting product launch success and market entry
Develop and implement sophisticated monitoring mechanisms and intervention strategies that optimize project outcomes and minimize business risks
Deliver projects that meet stringent requirements for technical quality, reliability, schedule adherence, and cost optimization, directly impacting profitability and market competitiveness
Serve as primary project interface for senior management and stakeholders, providing strategic insights and recommendations that influence organizational decision-making
Lead budget development processes and conduct impact analysis for project changes, ensuring optimal resource allocation and financial performance

Requirements

Education

Degree and / or Masters in engineering or technical field

Experience

10+ years of new product development (medical device engineering) and/or 10+ years of applicable project or program management experience in medical devices, healthcare or pharma development environment

Required Skills

Applying project management tools to manage New Product Development Programs Applying project management tools to manage Sustaining Engineering Projects Building, managing and maintaining business partnerships Applying knowledge of ISO standards and FDA Design Control regulations Strong understanding of medical device regulations including FDA standard 21 CFR Parts 801 and 820, design controls, ISO13485, regulatory audits and international environmental regulations Extensive experience and track record of success in the development of 510K/PMA regulated products Strong experience in people management and organisational development / alignment in line with budget and business needs Possesses interpersonal skills to negotiate and reconcile differences, while optimizing overall business goals Excellent written and verbal communications skills with strong competency in MS Office tools and Project management applications

Certifications

Certification in Process Excellence (Green Belt or Black Belt) or project management certification PMP is a plus
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Sauge AI Market Intelligence

Industry Trends

The medical device industry is experiencing unprecedented regulatory complexity with evolving FDA guidelines and international harmonization requirements, creating high demand for professionals who can navigate both technical development and regulatory compliance simultaneously. This trend is particularly pronounced in electromechanical and software-controlled devices where traditional engineering expertise must be combined with deep regulatory knowledge. Digital transformation in medical device development is driving the need for project managers who understand both traditional manufacturing processes and emerging technologies like IoT integration, data analytics, and connected health platforms. Companies are increasingly seeking leaders who can bridge the gap between legacy device engineering and next-generation smart medical technologies. Post-pandemic supply chain disruptions and increased focus on manufacturing resilience have elevated the importance of project managers with outsourced manufacturing experience and global supply chain understanding, particularly in sterile disposable devices and complex electromechanical systems.

Role Significance

Typically manages matrix teams of 8-15 professionals across engineering, quality assurance, regulatory affairs, clinical, operations, finance, and commercial functions. The role involves both direct people management responsibilities (30% organizational leadership focus) and indirect influence over larger cross-functional project teams.
This is a senior leadership position with significant organizational influence, responsible for strategic project portfolio management and cross-functional leadership. The role carries accountability for high-stakes projects that directly impact company competitiveness and regulatory compliance, indicating C-suite visibility and board-level reporting responsibilities.

Key Projects

FDA 510K and PMA submission projects for new medical device approvals Complex electromechanical device development programs with software integration Global manufacturing transition and outsourcing initiatives Design control implementation and regulatory compliance projects International market expansion projects requiring multi-regional regulatory alignment

Success Factors

Deep expertise in FDA regulatory pathways and international medical device standards, as regulatory missteps can result in years of delays and millions in lost revenue. Success requires not just knowledge but proven ability to navigate complex approval processes while maintaining project momentum. Exceptional cross-functional leadership capabilities, as medical device development requires seamless coordination between traditionally siloed departments with conflicting priorities and timelines. The ability to influence without direct authority is critical for success. Strategic thinking combined with operational excellence, as the role demands both high-level strategic alignment and detailed execution management. Success requires balancing long-term organizational objectives with immediate project delivery pressures. Risk management expertise specific to medical device development, where technical failures can have patient safety implications and regulatory consequences. Success depends on proactive risk identification and mitigation planning. Change management skills for navigating the rapidly evolving regulatory landscape and technological advances in medical devices, requiring continuous adaptation of processes and team capabilities.

Market Demand

High demand. The combination of technical project management expertise, medical device regulatory knowledge, and proven track record with FDA submissions represents a scarce skill set in the market. Dublin's growing medtech sector and Brexit-related relocations have intensified competition for experienced medical device project managers.

Important Skills

Critical Skills

FDA regulatory expertise is absolutely critical as medical device approval processes are highly specialized and mistakes can result in years of delays and substantial financial losses. The specific mention of 510K/PMA experience indicates this role involves high-risk, high-value regulatory submissions. Cross-functional leadership capabilities are essential because medical device development requires orchestrating diverse teams with competing priorities, tight timelines, and strict quality requirements. Success depends entirely on the ability to influence and align stakeholders without direct authority. Risk management and problem-solving skills are critical because medical device projects involve patient safety considerations, regulatory compliance requirements, and significant financial investments. The ability to anticipate and mitigate risks proactively determines project success.

Beneficial Skills

Process Excellence certification (Lean Six Sigma) is increasingly valuable as medical device companies focus on operational efficiency and cost reduction while maintaining quality standards. These skills provide competitive advantage in optimization projects. Software and connected device experience is becoming essential as medical devices increasingly incorporate digital technologies, IoT connectivity, and data analytics capabilities. This expertise positions professionals for next-generation device development projects. International manufacturing and supply chain experience is highly valuable given global sourcing trends and the need for resilient supply chains post-pandemic. This expertise enables leadership of complex manufacturing transition projects.

Unique Aspects

The combination of new product development and sustaining engineering responsibilities in a single role is unusual and indicates a lean organizational structure where senior professionals wear multiple hats, providing broader experience but requiring exceptional versatility.
The specific focus on both FDA and international regulatory requirements suggests involvement in global product launches and multi-market strategies, providing exposure to complex international business dynamics.
The emphasis on external development partnerships (20% focus area) indicates involvement in strategic alliances and technology licensing, providing exposure to business development and corporate strategy functions.
The role's positioning within Global Device Engineering suggests involvement in worldwide standardization initiatives and technology transfer projects, providing unique exposure to international operations.

Career Growth

3-5 years to director level, 5-8 years to VP or CTO positions, depending on company size and market conditions. The specialized nature of medical device expertise and regulatory knowledge accelerates career progression compared to general project management roles.

Potential Next Roles

Director of Program Management or VP of Engineering positions within medical device companies Chief Technology Officer roles in mid-size medtech organizations Regulatory Affairs Director positions leveraging deep FDA experience General Manager roles for medical device business units Consulting leadership positions with major medtech consulting firms

Company Overview

Mallinckrodt

Mallinckrodt is a global specialty pharmaceutical and medical device company with significant presence in hospital and specialty care markets. The company has undergone substantial restructuring in recent years and maintains focus on critical care medications and medical devices, particularly in hospital settings and specialty therapeutic areas.

Mallinckrodt operates as a mid-to-large tier specialty pharmaceutical company with established market presence in critical care and hospital markets. The company's medical device operations represent a strategic growth area, particularly in the European market where this Dublin-based role is positioned.
The Dublin location represents Mallinckrodt's European operations hub, strategically positioned for EU market access and regulatory compliance. This role likely supports both European market development and serves as a bridge to global operations, indicating significant regional responsibility and visibility.
The role structure suggests a matrix-driven, process-oriented culture typical of regulated pharmaceutical and medical device environments. The emphasis on cross-functional collaboration, budget accountability, and strategic alignment indicates a results-focused culture with strong emphasis on compliance and risk management.
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