Senior Director of Operations
Position Summary:
We are seeking a seasoned Sr. Director of Operations to lead and evolve our medical device manufacturing capabilities. This role is critical in driving operational excellence, aligning cross-functional teams, and ensuring the delivery of high-quality products in a regulated environment. The ideal candidate brings deep industry experience, strategic insight, and a passion for continuous improvement.
Key Responsibilities:
- Develop and execute the manufacturing strategy in collaboration with senior leadership
- Contribute to the advancement of business systems and a high-performance work culture
- Ensure timely delivery of high-quality products aligned with business goals
- Serve as the primary operations liaison with external partners and suppliers
- Partner with engineering and strategic operations to implement capital projects and scale production
- Evaluate manufacturing systems and implement efficiency improvements
- Define and track key performance indicators (KPIs) for safety, quality, delivery, and cost
- Drive cost reduction and labor productivity initiatives
- Lead, mentor, and develop a high-performing management team
- Establish effective planning, accountability, and communication processes
- Foster a culture of innovation, collaboration, and continuous learning
- Champion the company's vision and values across all levels of the organization
Required Qualifications:
- Bachelor's degree (Engineering preferred)
- 15+ years of experience in medical device development or high-volume manufacturing
- Proven leadership in cross-functional team alignment and strategic execution
- Strong understanding of regulated manufacturing environments
- Expertise in manufacturing metrics, ERP systems, inventory, and budgeting
- Knowledge of GMP and current regulatory standards
Preferred Qualifications
- Master's degree
- Experience with combination products
- Six Sigma Black Belt or equivalent continuous improvement expertise
- Equipment maintenance and validation experience in regulated settings
- Background in medical device or pharmaceutical manufacturing
- Familiarity with automation and standard device assembly methods
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