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Senior Manager for the West & Northwest at Collins McNicholas Recruitment & HR Services Group
Our client, a disruptive and high potential scale up, based and developed out of Galway, is growing its operations and currently looking to hire a Manufacturing Process Engineer. The Company is committed to improving patient outcomes in a minimally invasive way and is actively working to develop leading-edge devices and products to treat musculoskeletal conditions.
Responsibilities:
* Provide day-to-day support to the line technician and product builders, in terms of troubleshooting equipment and process-related issues. Provide training to line technicians.
* Manage the manufacturing process, understand the process risks, and identify mitigations leading to improving yields and process efficiency.
* Work with equipment vendors to identify areas for process improvement.
* Create a strong culture of problem-solving using standard tools like DMAIC and Six Sigma.
* Create and follow a process development plan ensuring budget, risk, and timeline have a high level of focus placed on them.
* Work closely with the R&D team to ensure their programs are also facilitated in the production plans.
* Work with R&D on materials, process, and equipment improvement projects.
* Create and update the existing master validation plan for the line equipment.
* Responsible for all line equipment in terms of maintenance and calibration.
* Execution of IQ/OQs for lab and production equipment.
* Communicate and update project activities using project management methodologies.
Background & Qualifications:
* Bachelors, Masters, or PhD degree in Science, Mechanical Engineering, Manufacturing, Chemical Engineering, Biomedical Engineering, or other relevant engineering discipline.
* At least 3 to 5 years of work experience in a manufacturing or process development-related role in a medical device company.
* Experience with new equipment introduction (IQ/OQ) and process characterization and validation.
* Experience with processes such as lyophilization, mixing, and dispensing would be an advantage.
* Demonstrated experience with GDP & GMP standards.
* Excellent knowledge of engineering materials used in medical device manufacture such as hydrogels, metals, and polymers.
* A strong problem solver with knowledge and experience of DMAIC or other problem-solving tools.
* Must be organized, demonstrate innovation, and have a strong work ethic on individual projects and as part of a project team.
* Effective communication skills, both verbal and written – English.
* Extremely comfortable with hands-on and technical work.
For more information on the role and a confidential discussion on the organization, please contact Chris O'Toole.
Seniority Level
* Mid-Senior level
Employment Type
* Full-time
Job Function
* Engineering, Manufacturing, and Science
Industries
* Manufacturing, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing
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