Senior Manufacturing Engineer

4 weeks ago

Cork, Cork, Ireland Novintix Full time

Overview
NovintiX is a fast-growing engineering and digital transformation consultancy serving top Life Sciences and MedTech firms across the US, Ireland, and Europe.
We deliver high-impact digital programs, engineering services, and talent solutions that support innovation, efficiency, and compliance.
Position
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You'll provide advanced technical support, lead process improvement initiatives, and contribute to quality, service, and cost optimisation using Value-Centered Engineering and Six Sigma tools.
Responsibilities
Deliver key improvements in Quality, Service, and Cost through structured engineering initiatives.
Act as technical lead on product and process issues and drive root cause analysis.
Drive process validation activities: IQ, OQ, PQ, VP, Gauge R&R, etc.
Develop SOPs, work instructions, and documentation aligned to GMP.
Lead cross-functional Continuous Improvement Programs (CIP).
Transfer processes across facilities and support New Product Introduction (NPI).
Provide engineering mentorship to technicians, operators, and engineers.
Lead Value Stream and Cross-Functional Projects as assigned.
Support audit readiness as a Subject Matter Expert (SME).
Ensure strict adherence to EHS and Quality Management Systems (QMS).
Qualifications
Level 8 Degree in Mechanical Engineering or related field.
2–4 years of experience in a regulated manufacturing environment (preferably MedTech).
Proven Project Management capabilities.
Hands-on experience in Process Validation and Problem Solving (Six Sigma).
Strong documentation and communication skills.
Autonomous, driven, and collaborative mindset.
Excellent leadership, decision-making, and influencing abilities.
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