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.
As a Manufacturing Engineer at FIRE1 you will play a crucial role in advancing our manufacturing processes from prototype/ small volumes to scalable, consistent production for our pivotal trial. Your role is essential to provide day-to-day line support for the manufacturing line building our Class III implantable sensor.
This role is offered on a 12-month fixed term contract basis, and reports to the Process Engineer.
Responsibilities:
* Hands-on Troubleshooting: Investigating, analysing, and resolving daily production bottlenecks, equipment failures, and process deviations.
* Rapid Response: Addressing unplanned events or machine downtime quickly to meet daily output targets.
* Monitoring: Monitoring performance metrics (yield, throughput) to identify, document, and fix issues.
* Non-Conformance (NC) Investigation: Investigating root causes of scrap, rework, or non-conforming products and implementing corrective actions (CAPA).
* Documenting Procedures: Creating, updating, and maintaining Manufacturing documentation to ensure compliance with GMP or ISO standards.
* Validation Support: Assisting with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and processes.
* Data Analysis: Using statistical tools to track product quality, evaluate process capabilities, and identify trends.
* Lean Methodologies: Implementing Lean Six Sigma, 5S, and Kaizen initiatives to eliminate waste, improve workflow, and reduce cost.
* Process Optimization: Identifying opportunities for efficiency improvements and conducting time studies or capacity analyses.
* Fixing Tooling/Fixtures: Designing or improving simple jigs, fixtures, or assembly tools to improve ergonomics and yield.
* Engage with the FIRE1 QMS to ensure delivery of the overall quality strategy & support the achievement of the business quality objectives
Qualification & Experience:
Essential:
* Bachelor's degree in engineering, science, manufacturing, or a related field.
* In-depth knowledge of manufacturing processes, ideally manual assembly of medical devices.
* Exposure to or proficient in statistical methods and tools to analyse and optimize processes.
Interpersonal:
* Cross-Functional Collaboration ability
* Strong written and verbal communication skills to present technical concepts clearly to both technical and non-technical audiences.
* Strong analytical and critical thinking skills to identify obstacles and develop effective solutions.
* Ability to prioritize tasks and manage multiple projects simultaneously, meeting deadlines and company objectives.
* High attention to detail for thorough documentation, process validation, and compliance efforts.
* Flexibility to adapt to changing requirements and priorities in a fast-paced manufacturing environment.
Desirable (but not essential):
* Previous work experience (intern, co-op or full time) in manufacturing engineering within a manufacturing environment, preferably in the medical device industry
* Experience with or knowledge of equipment qualification, total productive maintenance, lean manufacturing and/ or the theory of constraints.
* Knowledge of FDA regulations and quality management systems related to Class III medical devices.
* Six Sigma, DMAIC, Shainin and other root cause investigation methodologies would be helpful.
* Equipment/ Fixture Design; Solidworks or other CAD experience, GDT principles desirable
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.