Drive Operational Excellence
Deliver key enhancements in efficiency, quality, and cost-effectiveness through structured engineering initiatives. Act as a technical lead on product and process issues, driving root cause analysis to optimize business outcomes.
Key Responsibilities:
* Develop and implement process validation strategies: IQ, OQ, PQ, VP, Gauge R&R, etc.
* Design and maintain SOPs, work instructions, and documentation aligned to industry best practices.
* Lead cross-functional Continuous Improvement Programs (CIP) to drive business growth.
* Transfer processes across facilities and support New Product Introduction (NPI) with minimal disruption.
* Provide technical mentorship to technicians, operators, and engineers, fostering a culture of knowledge sharing.
* Lead Value Stream and Cross-Functional Projects as assigned, ensuring timely delivery and stakeholder satisfaction.
* Support audit readiness as a Subject Matter Expert (SME), maintaining the highest standards of regulatory compliance.
Requirements:
* Bachelor's or Master's Degree in Mechanical Engineering or related field.
* Minimum 24 years of experience in regulated manufacturing environments, preferably in the medical technology sector.
* Demonstrated Project Management expertise, with a proven track record of delivering results-oriented projects.
* Hands-on experience in Process Validation and Problem Solving (Six Sigma), with a strong focus on data-driven decision-making.
* Excellent documentation and communication skills, with the ability to articulate complex ideas in a clear and concise manner.
* Ambitious, driven, and collaborative mindset, with a passion for leading high-performing teams.
* Exceptional leadership, decision-making, and influencing abilities, with a strong track record of achieving business objectives.