Job Opportunity: Senior Manufacturing Engineer
As a seasoned Senior Manufacturing Engineer, you will play a pivotal role in driving quality, service, and cost improvements through strategic engineering initiatives.
Key Responsibilities:
* Provide technical leadership on product and process issues, facilitating root cause analysis to drive effective solutions.
* Develop and implement process validation activities, including IQ, OQ, PQ, VP, and Gauge R&R protocols.
* Establish SOPs, work instructions, and documentation aligned with GMP standards.
* Lead cross-functional Continuous Improvement Programs (CIP), fostering collaboration and innovation.
* Transfer processes across facilities and support New Product Introduction (NPI) projects.
* Offer engineering mentorship to technicians, operators, and engineers, promoting knowledge sharing and growth.
* Lead Value Stream and Cross-Functional Projects as assigned, ensuring timely delivery and high-quality results.
* Support audit readiness as a Subject Matter Expert (SME), providing expert insights and guidance.
Requirements:
* Level 8 Degree in Mechanical Engineering or a related field.
* 24 years of experience in a regulated manufacturing environment (preferably MedTech).
* Proven Project Management capabilities, with a track record of delivering successful projects.
* Hands-on experience in Process Validation and Problem Solving (Six Sigma), with a strong focus on quality and efficiency.
* Excellent documentation and communication skills, with the ability to articulate complex ideas simply.
* A collaborative mindset, with a passion for working effectively within teams.
* Strong leadership, decision-making, and influencing abilities, with a talent for inspiring others.