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 Production Operator you will assemble, to the highest degree of quality, the sterile implantable sensor that is the key to FIRE1's Class III medical device, Norm, for helping patients living with heart failure get back to their normal lives.
Production is accomplished by carefully following assembly procedures to assemble the sensor using very small components. Assembly requires steady hands, excellent vision, detail orientation and frequent use of microscopes. Assembly also includes packaging and shipping of product.
This role is offered on a 12-month fixed term contract basis, and reports to the Senior Line Lead.
Responsibilities:
* Work in cleanroom and non-cleanroom ESD environments to manufacture and package medical device product and components.
* Maintain safe and clean work environment by following current good manufacturing practices (cGMP), and standard operating procedures; complying with legal regulations; monitoring environment
* Maintain accurate and legible records and production documentation
* Liaise with engineering and technicians to assist in troubleshooting production issues
* Engage with the FIRE1 QMS to ensure delivery of the overall quality strategy & support the achievement of the business quality objectives
* Keep equipment operating by following operating instructions; troubleshooting breakdowns; calling for repairs. Share responsibility for the maintenance and upkeep of the manufacturing environment, tools and equipment.
* Provide support and feedback to leadership and engineering for ensuring accuracy of the production documentation, continuous Improvement of our processes and GMP guidelines
* Other assembly duties or assembly support duties as required
Qualification & Experience:
* QQI Level 5 Major Award, Apprenticeship or relevant experience.
* Excellent manual dexterity
* Excellent (corrected) vision, 3D vision/ depth perception
* Ability to read and follow written instructions in English
* Will seek for clarification if instructions aren't clear
* Attention to detail and ability to focus
* Accurate record keeping and documentation skills, legible handwriting
* Verbal communication skills
* Proven ability to work well as both part of a team and independently with minimal supervision
* Drive to achieve daily goals
Desirable (but not essential):
* Highly regulated industry experience, especially medical device, but could also be pharma or other industry with strict regulations.
* Comfort/ previous daily experience working with a microscope (inspecting or assembling) is highly desirable
* Cleanroom manufacturing experience
* Experience working in a Lean Manufacturing Environment
* Soldering or laser welding experience helpful (e.g. jeweller's laser)
* Problem-solver
* Ability to self-start and take on responsibility
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.