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.
In this pivotal role, you’ll be a core member of our cross-functional management team; translating strategy, driving innovation, and enabling development as the device moves into a critical clinical trial phase and through to commercialisation. You will divide your time between strategic direction and hands-on process development, making this a fantastic opportunity if you are looking to have strategic impact whilst staying close to the operational process development that you are passionate about.
Responsibilities
- Act as core member of FIRE1’s cross-functional management team
- Lead process development for a novel Class III implantable device
- Establish and implement process development strategy
- Align process development activities with business goals, regulatory requirements, and market needs
- Manage budgets, resources, and timelines to ensure successful process development
- Develop and validate manufacturing processes, including prototyping, scale-up, and technology transfer
- Demonstrate process capabilities using statistical tools and techniques
- Take ownership of process validation protocols (IQ/OQ/PQ) to ensure compliance and product quality
- Troubleshoot and resolve complex manufacturing and process issues to minimise downtime and improve efficiency
- Lead and develop the process engineering team. Mentor the team & develop their skills and capabilities to full potential
- Build and maintain strong relationships with external partners, suppliers, and regulatory agencies
- Oversee the successful scale-up of processes to commercial manufacturing volumes
Qualification & Experience
- Managed & led process development teams
- 10+ years’ experience in Class II – Class III (preferably) implantable medical devices
- Has led 5+ new product introductions into cleanroom manufacturing environments
- Demonstrated expertise in scaling processes from initial R&D into commercial launch / volumes
- Proven cross-functional leader – works closely with R&D, Manufacturing, Quality, Regulatory, and suppliers
- Great communicator – both technical/ functional & capable of interacting with non-engineers; ideally experience of engaging with Board members & investors
- Hands-on experience with process development, characterisation, validation, tech transfer, and troubleshooting
- Deep knowledge of statistical approaches to process development (Lean Six Sigma black belt preferred) including DOE, MSA, RSM, SPC, CPK, ANOVA etc.
- Extensive process automation leadership experience including the design, development and implementation of custom process automation equipment
- Strong knowledge of regulatory standards
Benefits
- 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.