Process Development Manager

Do you want to help improve the lives of millions of people?

We are developing cutting edge technology to reinvent the treatment of heart failure globally. If you are interested in joining a dynamic team that is working hard to change the world for the better, we'd love to talk to you.

The Process Development Manager is responsible for leading the Process Development function to support FIRE1's strategic and operational objectives. The role provides technical and people leadership across multiple complex development and manufacturing improvement projects, delivering innovative process solutions, yield improvements, operational excellence, and capability development. The successful candidate will act as a change agent, driving process innovation, fostering collaboration, and developing high-performing teams while ensuring projects are delivered on time and to the required quality standards.

Responsibilities

• Strategic Leadership
  • Develop and communicate the strategic direction for the Process Development function in alignment with company objectives.
  • Lead and inspire a team of engineers and technical professionals to achieve operational and business goals.
  • Act as a change leader, driving continuous improvement initiatives across manufacturing and development operations.
  • Promote a culture of innovation, accountability, collaboration, and high performance.
• People Management & Development
  • Build, lead, coach, and develop a high-performing Process Development team.
  • Drive employee engagement, performance management, succession planning, and talent development activities.
  • Establish clear goals and performance expectations while supporting individual and team growth.
  • Determine appropriate staffing levels, resource requirements, and organisational structures to support current and future business needs.
• Process Development & Improvement
  • Lead complex process development activities from concept through implementation and transfer to manufacturing.
  • Drive yield improvement, process optimisation, cost reduction, and operational excellence initiatives.
  • Identify opportunities to improve manufacturing robustness, efficiency, and scalability.
  • Apply data-driven methodologies and structured problem-solving techniques to address technical and operational challenges.
• Technical Leadership
  • Serve as a technical expert in process development and manufacturing improvement.
  • Lead root cause investigations and resolution of complex technical issues.
  • Champion the use of statistical analysis, risk management, and continuous improvement methodologies.
  • Ensure technical decisions are supported by sound engineering principles and objective data.
• Cross-Functional Collaboration
  • Foster teamwork and strong working relationships across Manufacturing, R&D, Quality, Regulatory, Supply Chain, and Clinical functions.
  • Build and lead cross-functional partnerships to identify, prioritise, and resolve technical and business challenges.
  • Facilitate effective communication across all levels of the organisation to drive alignment and execution.
  • Support organisational initiatives requiring cross-functional leadership and engagement.
• Project Management
  • Lead and manage multiple complex projects simultaneously.
  • Establish project plans, budgets, resource requirements, milestones, and risk mitigation strategies.
  • Ensure projects are delivered to predetermined schedules while maintaining quality and compliance standards.
  • Provide regular project updates and communicate risks, issues, and opportunities to stakeholders and senior leadership.
• Quality & Compliance
  • Ensure all activities comply with FIRE1 Quality Management System requirements and applicable regulatory standards.
  • Support process validation, risk management, design transfer, and manufacturing readiness activities.
  • Drive compliance with Health & Safety requirements and promote a safe working environment.
  • Engage with the FIRE1 QMS to ensure delivery of the overall quality strategy and support achievement of business quality objectives.
• Support business planning and resource allocation activities.
• Ensure effective utilisation of resources while balancing operational priorities and strategic objectives.

Qualifications

• Bachelor's Degree in Engineering, Manufacturing Engineering, Biomedical Engineering, Mechanical Engineering, Industrial Engineering, or related discipline.
• Minimum 8-10 years' experience in a regulated manufacturing or medical device environment.
• Minimum 3-5 years' experience leading engineering, process development, or manufacturing teams.
• Demonstrated success delivering multiple complex projects involving process improvements, yield improvements, and operational excellence initiatives.
• Proven experience managing technical teams and developing engineering talent.
• Experience leading change initiatives and driving organisational improvement.
• Strong project management experience with a track record of delivering results to predetermined schedules.
• Strong leadership and people management capability.
• Exceptional technical problem-solving and analytical skills.
• Strategic thinking combined with hands-on execution.
• Ability to influence and drive change across organisations.
• Excellent communication and stakeholder management skills.
• Resource planning and workforce management expertise.
• Advanced project management capabilities.
• Data-driven decision-making and continuous improvement mindset.
• Strong organisational and prioritisation skills.
• Ability to make sound decisions in a dynamic and fast-paced environment.
• Master's Degree in Engineering, Operations Management, or related discipline.
• Lean Six Sigma Green Belt, Black Belt, or equivalent qualification.
• Experience scaling manufacturing processes in a fast-growing medical device organisation.
• 25 days annual leave
• Competitive health insurance plan with VHI
• Pension 8% employer contribution
• Employee share ownership programme
• Discretionary bonus plan
• Discounted gym membership at DCU & UCD gyms
• Taxsaver Commuter Tickets & Bike to Work Scheme
• EAP (Employee Assistance Programme)
• Employer funded Sports & Social Committee

Our Values

• We are a team -We are a diverse team who respect each other's opinions. We work and learn together in an open and honest way to achieve our ambitious purpose.
• We care about our patients - We are determined to give our patients their normal back and strive to continuously improve the patient experience. We appreciate the sacrifice they make to be in our study.
• We are pioneers -We embrace the uncertainty of trying something new & appreciate the privilege we have to build a company that will improve millions of lives.
• We are ambitious -We are purpose-driven & will deliver the market leading, self-management product for heart failure, to give millions of patients their normal back.