Unit 4D, Western Business Park, Shannon, Co. Clare
Job Description
The Manufacturing Engineer will play a pivotal role in scaling up manufacturing processes from development to commercial production with a focus on new equipment introduction process optimization and validation.
This position requires a candidate who can lead the procurement qualification and integration of manufacturing equipment while ensuring regulatory compliance operational efficiency technical excellence in manufacturing operations high-quality production at scale collaboration cross functionally to achieve project milestones.
Key Responsibilities
* Lead the selection procurement installation and commissioning of new manufacturing equipment utilities to support scale-up commercialization efforts.
* Collaborate with suppliers to evaluate qualify new equipment ensuring compliance with design specifications regulatory standards.
* Train team members on the operation maintenance of newly introduced equipment.
* Support manufacturing onsite subcontractors/suppliers to ensure product quality regulatory business requirements are met.
* Track report progress across project activities reviewing schedules due dates identifying risks implementing contingency plans communicate effectively internal external stakeholders.
* Lead transition/design transfer of manufacturing processes R&D production ensuring scalability cost-effectiveness.
* Develop execute pFMEAs identify potential failure modes assess risks implement effective controls manufacturing processes.
* Optimize manufacturing workflows identify opportunities efficiency improvements.
* Support timely introduction process upgrades developing executing equipment qualification protocols IQ/OQ/PQ integrating them overall process validation framework.
* Act subject matter expert manufacturing technologies troubleshooting complex process issues implementing robust solutions.
* Assess approve process changes ensuring product impact appropriately considered compile necessary equipment/capital authorization requests supported justifications alternative options.
* Collaborate key suppliers production/manufacturing teams drive support process/product improvements/developments.
* Ensure health safety environmental requirements met.
* Ensure compliance medical device regulatory requirements FDA ISO 13485 standards.
* Provide guidance mentorship junior engineers technicians fostering culture continuous learning professional growth.
* Perform other related duties assigned supervisor.
Requirements
* Bachelor's Master's degree Mechanical Engineering Biomedical Engineering Manufacturing Engineering related field.
* Minimum 3-5 years experience manufacturing engineering preferably medical device pharmaceutical industries.
* Strong expertise process validation equipment qualification regulated industries.
* Qualifications education specialized knowledge manufacturing powders particle processing granulation techniques safety quality control process optimization highly advantageous.
* Knowledge interpretation FDA guidelines ISO 13485 requirements working knowledge international standards applicable.
* Proficient lean manufacturing Six Sigma process improvement methodologies.
* Ability manage multiple projects prioritize workload effectively meet project deadlines.
* Excellent communication interpersonal presentation skills.
* Strong technical acumen understand complex technical concepts/issues develop practical solutions.
* Strong attention detail work meticulously ensure accuracy testing documentation.
Note This description reflects essential functions does not prescribe nor restrict tasks may be assigned.