POSITION REPORTS TO: Chief Operating Officer
ESSENTIAL DUTIES AND RESPONSIBILITIES:
QUALITY
• Serve as the primary owner of product and process quality, ensuring compliance with ISO 13485:2016 and applicable medical device regulations (US, EU, Canada).
• Adhere to and continuously improve the Quality Management System (QMS), ensuring full documentation and compliance.
• Drive Six Sigma and Lean initiatives to embed a culture of data-driven quality improvements.
• Collaborate cross-functionally to establish and maintain best-in-class standards for product and service quality.
• Ensure that continuous improvement projects focus on root cause determination and correction and long-term quality reliability.
COST
• Own the manufacturing operations P&L, budget planning, and cost control strategies.
• Analyze financial statements and performance data to identify cost-saving opportunities and productivity improvements.
• Lead and support capital project execution and cost-reduction programs, with a focus on ROI.
• Optimize work center capacity and shop floor efficiency through intelligent resource allocation and automation strategies.
• Deliver cost-effective manufacturing solutions without compromising product quality or compliance.
DELIVERY
• Ensure on-time delivery (OTD) targets are met through effective production planning, resource scheduling, and throughput optimization.
• Oversee daily manufacturing operations to meet customer requirements and company delivery objectives.
• Establish and implement scalable, automated manufacturing processes to improve responsiveness and reduce lead time.
• Monitor and reduce past-due orders while improving production cycle times and flexibility.
SAFETY
• Foster a safety-first culture across all manufacturing sites and functions and ensure adherence to all applicable safety standards and regulatory requirements.
• Lead all Environmental Health and Safety (EHS) efforts to minimize workplace hazards and improve safety performance metrics.
• Embed safety considerations into all continuous improvement and capital investment initiatives.
• Train teams on safe practices and audit adherence to reinforce a zero-incident environment.
MORALE
• Build and lead a high-performing, empowered team through mentoring, training, and performance management.
• Promote a culture of accountability, recognition, and continuous development.
• Communicate clearly and frequently to ensure alignment, motivation, and transparency at all levels.
• Foster an environment of collaboration, open communication, and inclusive decision-making.
• Provide regular performance updates to senior leadership and communicate wins and challenges to the team to boost morale and engagement.
MINIMUM REQUIREMENTS
• Bachelor’s degree in a science or engineering discipline required; MBA or Master’s degree in a related field strongly preferred.
• Minimum of five years of progressively responsible leadership experience in manufacturing operations, ideally within the medical device or similarly regulated industry.
• Proven track record of instilling a culture of accountability, ownership, and continuous improvement across diverse manufacturing teams.
• Demonstrated success in building and sustaining high-performance, empowered teams that consistently achieve or exceed operational targets.
• Strong, hands-on experience with plastic injection molding, packaging, assembly, and metal fabrication processes in a regulated manufacturing environment.
• Experience with robotics integration and vision systems for automation, quality inspection, or process control.
• Proficiency with ERP, MRP, and production scheduling systems, and a data-driven approach to visibility, traceability, and optimization.
• Deep understanding of ISO 13485:2016 and medical device regulatory requirements across the US, EU, and Canada.
• Lean manufacturing and Six Sigma experience; Green or Black Belt certification preferred.
• Demonstrated ability to manage operational budgets, lead cost-reduction initiatives, and drive P&L improvements through operational excellence.
• Strong leadership, communication, and interpersonal skills with the ability to influence, motivate, and align teams across all levels.
• Able to manage and execute multiple complex projects in a fast-paced, deadline-driven environment.
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