Position Overview:We are seeking a strategic and results-driven Director of Operations to lead our Bloomfield, CT and Willington, CT medical device testing and manufacturing facilities. This role is responsible for overseeing all aspects of the day-to-day operations, driving efficiency, and ensuring compliance with regulatory standards. The Director will collaborate cross-functionally with our Quality and Commercial teams to ensure on-time delivery of services while maintaining the highest standards of quality and client satisfaction.
Key Responsibilities:- Lead and manage laboratory and production operations related to medical device testing and manufacturing (mechanical, biocompatibility, packaging, shelf-life, etc.).
- Develop and execute operational strategies that align with company goals and regulatory requirements (FDA, ISO 17025, ISO 13485, etc.).
- Oversee resource planning, scheduling, and capacity management to ensure timely project delivery.
- Implement continuous improvement initiatives focused on throughput, cost efficiency, and quality assurance.
- Monitor KPIs and operational metrics to drive accountability and performance across teams.
- Ensure staff are trained, motivated, and operating in compliance with safety and quality protocols.
- Collaborate with Quality Assurance and Regulatory Affairs teams to maintain compliance and prepare for audits.
- Lead capital planning and process optimization initiatives for laboratory equipment and operational systems.
- Serve as a key operational point of contact for clients and internal stakeholders.
Qualifications:- Bachelor's degree in engineering, Operations, Life Sciences, or related field required; Master's degree or MBA preferred.
- 10+ years of progressive leadership experience in operations within the medical device, pharmaceutical, or diagnostics industry.
- Strong understanding of laboratory operations, quality systems, and regulatory compliance.
- Experience with Lean, Six Sigma, or other process improvement methodologies.
- Proven success in leading cross-functional teams, managing budgets, and scaling operations.
- Exceptional leadership, communication, and analytical skills.
To learn more about Millstone Medical and Millstone Medical Testing and to apply for this opportunity, please visit us online at https://millstonemedical.com/join-our-team/.
