Job Description
Job Description
At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader, and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products, and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.
Abbott Ireland
In Ireland, Abbott employs over 6,000 people across ten sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford, and Sligo, and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations, and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.
Abbott Diagnostics
As a result of strong business growth, industry-leading product development in the Diagnostics ("Core Lab") business, and continued commitment to manufacturing at our European sites, we now have an opportunity for a Manufacturing Process Engineer – Moulding, to join our global Division Engineering team, working with our cGMP manufacturing sites and suppliers/partners in Ireland and across Europe.
Primary Function
You will bring your technical as well as project engineering expertise in injection moulding design and manufacturing to attain engineering objectives for the Abbott Diagnostics Division.
Job Description
- Provide end-to-end engineering oversight, technical support, and consultancy to suppliers on moulding process development, design for manufacture (DFM), material selection, and process validations.
- Support the efforts on NPI and tech transfers for associated processes, FAT, and validation of moulding manufacturing cells in accordance with division engineering best practices and procedures.
- Act as the subject matter expert for injection mould process and the development of an entire moulding manufacturing cell.
- Understand all moulding cell equipment from mould, moulding machines, EoAT, machine side automation, etc.
- Understand Scientific/Decoupled Moulding methodologies and design of experiment (DOE) tools and software to maximize process window.
- Full understanding and development of the relationship between moulding key process input variables (KPIVs) and key process output variables (KPOVs) for plastic components throughout the value stream.
- Facilitate Factory Acceptance Testing (FAT) at equipment manufacturers per equipment URS and mould build standards.
- Provide technical process support to other engineers within the group and mentor and develop junior associates.
- Learn, challenge, develop and maintain a working knowledge of Abbott Quality Policy and Procedures.
Key Responsibilities
The Manufacturing Process Engineer - Moulding is responsible for the design, development, implementation, and ongoing support of medical moulded plastic parts for Core Lab (Abbott Diagnostics).
- Serves as a subject matter expert in the field of moulding and manufacturing process within the regional engineering team.
- Supports multiple projects and initiatives, including new product launches, scale up, on-market, and end of life management.
- Inputs to project schedules, resource assignment and deliverables, as well as assessing project risks and managing issues to resolution.
- Works regularly with operations, supply chain, quality, and various suppliers/partners.
- Manages implementation and oversight of measurement system analysis, design control, and executing equipment selection, process development, validation, FMEA, and Design of Experiments (DOEs).
- Ensures compliance with safety regulations, policies, and procedures. Responsible for implementing and maintaining the effectiveness of the quality system.
Education and Experience
- Third level qualification (Diploma or Degree) in a technical discipline such as Plastics/Polymer Engineering, Mechanical Engineering, Manufacturing Engineering etc., or over 4 years equivalent experience in the plastic injection moulding, ideally in the medical device/Pharma industry.
- Experience in injection moulding manufacturing in a high volume and highly regulated environment in the pharma/medical device industry.
- Knowledge of mould making and design fundamentals, moulding process development, plastic resin behaviour and required tooling/equipment.
- Project execution experience, in a regulated, med device or pharma capacity.
- Data analytics and statistical analysis capability.
- Knowledge of FDA QSR's and ISO requirements preferred.
Key Skills
- Ability to work in a highly matrixed and geographically diverse business environment.
- Effective project management.
- Proven troubleshooting skills along with validation experience.
- Excellent communication/interpersonal skills.
- Enthusiastic and energetic with the ability to integrate quickly into a team environment.
- Demonstrated flexible and innovative approach to work.
- Travel 10% of the time, including international.