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Job Description
Abbott is seeking a Manufacturing Process Engineer – Moulding to join its global Division Engineering team, working with cGMP manufacturing sites and suppliers/partners in Ireland and across Europe.
Abbott is a global healthcare leader with a portfolio of life-changing technologies spanning diagnostics, medical devices, nutritional products, and branded generic medicines. The company employs over 6,000 people across ten sites in Ireland, with a presence in Clonmel, Cootehill, Donegal, Kilkenny, Longford, and Sligo.
Job Description
The Manufacturing Process Engineer – Moulding will bring technical and project engineering expertise in injection moulding design and manufacturing to attain engineering objectives for the Abbott Diagnostics Division.
- 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 process, 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
- Serve as a subject matter expert in the field of moulding and manufacturing process within the regional engineering team.
- Support multiple projects and initiatives, including new product launches, scale up, on-market, and end-of-life management.
- Input to project schedules, resource assignment, and deliverables, as well as assessing project risks and managing issues to resolution.
- Work regularly with operations, supply chain, quality, and various suppliers/partners.
- Manage implementation and oversight of measurement system analysis, design control, and executing equipment selection, process development, validation, FMEA, and Design of Experiments (DOEs).
- Ensure compliance with safety regulations, policies, and procedures. Responsible for implementing and maintaining the effectiveness of the quality system.
Requirements
- 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 and 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.