Senior Director of Operations - Job Opportunity at Complete Staffing Jobs

Gardner, US
Full-time
Executive
Posted: June 12, 2025
On-site
USD 175,000 per year

Key Responsibilities

Orchestrate comprehensive manufacturing operations ecosystem encompassing supply chain optimization, material planning excellence, and inventory management to achieve superior quality, cost efficiency, and delivery performance across diverse product portfolios
Spearhead transformational strategic initiatives that revolutionize manufacturing processes while systematically scaling operational capacity and technological capabilities to support aggressive growth trajectories
Architect and execute sophisticated operational frameworks, scheduling systems, and quality assurance protocols that ensure consistent product conformance to stringent specifications across both high-mix low-volume and high-volume production environments
Exercise full P&L accountability for operations division while establishing, monitoring, and optimizing critical performance indicators that drive measurable business impact and operational excellence
Lead cross-functional collaboration in product development and new product introduction programs, ensuring seamless integration of design for manufacturability, testability, and cost optimization principles
Oversee comprehensive ERP system optimization including MRP functionality, standardized transactional workflows, cost management protocols, and end-to-end product traceability systems
Cultivate high-performance organizational culture anchored in Lean manufacturing principles, continuous improvement methodologies, and innovative best practices that maximize productivity while minimizing operational costs
Provide strategic leadership and professional development to manufacturing engineering teams while managing complex new product introduction processes that accelerate time-to-market capabilities
Ensure rigorous compliance with regulatory frameworks including FDA QSR, ISO 13485, and comprehensive quality management systems while maintaining operational efficiency
Direct specification, implementation, and ongoing optimization of advanced manufacturing facilities including bio-controlled ISO Class 7 cleanrooms and large-scale infrastructure projects
Represent organization in high-stakes customer negotiations involving pricing strategies, manufacturing agreements, and quality commitments that strengthen long-term partnerships
Collaborate with executive leadership in formulating comprehensive strategic planning initiatives, organizational policies, and operational objectives that align with corporate vision and market positioning

Requirements

Education

Bachelor's degree in industrial or mechanical engineering, or a related technical field; or an equivalent combination of education and experience. Master's degree in engineering or business preferred.

Experience

10+ years' experience in manufacturing and/or manufacturing engineering management, preferably in process-oriented operations in a regulated environment. A minimum of 5 years' experience managing a significant segment of a large manufacturer or the entire operation of a smaller manufacturer.

Required Skills

Demonstrated experience in scheduling, manufacturing resource & capacity planning, sourcing, and building strong relationships with employees and vendors Proven success in transforming manufacturing processes and driving Lean principles to improve quality and efficiency; rollout of Lean manufacturing methods and tools Demonstrated organizational and leaderships skills; demonstrated ability to scale operations by creating and implementing new organizational structures and roles to support rapid growth Experience with setting up and managing Cleanrooms, ERP system implementation & usage Medical device FDA QSR and ISO 13485 experience required; defense/aerospace experience desired Proficiency with Microsoft 365 apps suite, and project management tools Strong leadership skills with the proven ability to inspire and motivate teams to achieve exceptional results

Certifications

FDA QSR ISO 13485
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Sauge AI Market Intelligence

Industry Trends

The medical device manufacturing sector is experiencing unprecedented growth driven by aging demographics, technological innovation, and increased healthcare spending, with global market valuations projected to exceed $800 billion by 2030. Companies are increasingly investing in advanced manufacturing capabilities, cleanroom technologies, and regulatory compliance infrastructure to capture market share in high-value therapeutic areas including cardiovascular devices, orthopedic implants, and minimally invasive surgical instruments. Digital transformation initiatives are revolutionizing manufacturing operations through Industry 4.0 technologies including IoT sensors, predictive analytics, and automated quality control systems. Medical device manufacturers are particularly focused on implementing comprehensive traceability systems, real-time monitoring capabilities, and data-driven decision making processes to meet stringent FDA requirements while optimizing operational efficiency and reducing time-to-market for critical healthcare products. Regulatory landscape complexity continues to intensify with evolving FDA guidelines, international harmonization requirements, and increased scrutiny of manufacturing processes. Companies are investing heavily in compliance infrastructure, quality management systems, and specialized expertise to navigate regulatory challenges while maintaining competitive positioning in global markets. This trend is driving significant demand for senior operations leaders with proven regulatory experience and process optimization capabilities.

Salary Evaluation

The compensation package of $175,000 annually represents competitive market positioning for senior operations leadership roles in medical device manufacturing, particularly considering the specialized regulatory requirements and cleanroom management expertise demanded. Comparable roles in major metropolitan areas typically command $160,000-$220,000 base salary plus performance incentives, equity participation, and comprehensive benefits packages reflecting the critical nature of operational leadership in regulated manufacturing environments.

Role Significance

Typical organizational structure includes direct supervision of 15-25 senior managers across manufacturing engineering, quality assurance, supply chain, and production departments, with indirect leadership responsibility for 100-200 manufacturing personnel including technicians, operators, and administrative support staff. The role requires sophisticated organizational design capabilities to scale operations and manage complex cross-functional initiatives.
This executive-level position represents the pinnacle of manufacturing operations leadership, carrying full P&L responsibility and strategic decision-making authority that directly impacts organizational success, market competitiveness, and long-term growth trajectory. The role demands comprehensive business acumen, advanced technical expertise, and proven ability to lead complex organizational transformations while maintaining operational excellence in highly regulated environments.

Key Projects

Implementation of comprehensive digital manufacturing systems including advanced ERP platforms, real-time production monitoring, and integrated quality management systems that enhance operational visibility and decision-making capabilities Design and construction of state-of-the-art manufacturing facilities including ISO Class 7 cleanrooms, specialized equipment installation, and validation protocols that support new product introduction and capacity expansion initiatives Development and execution of lean manufacturing transformation programs that systematically eliminate waste, optimize workflows, and establish continuous improvement cultures resulting in measurable cost reduction and quality enhancement Leadership of new product introduction programs that accelerate time-to-market through cross-functional collaboration, design optimization, and manufacturing process validation while ensuring regulatory compliance and quality standards

Success Factors

Exceptional strategic thinking capabilities combined with hands-on operational expertise enable effective navigation of complex manufacturing challenges while maintaining focus on long-term organizational objectives and market positioning requirements Advanced regulatory knowledge and compliance experience provide foundation for managing FDA inspections, maintaining quality certifications, and implementing robust quality management systems that protect organizational reputation and market access Proven change management and organizational development skills facilitate successful implementation of lean manufacturing principles, digital transformation initiatives, and cultural improvements that drive sustainable operational excellence Strong financial acumen and P&L management experience ensure effective resource allocation, cost optimization, and performance measurement that directly contribute to organizational profitability and competitive advantage Superior leadership and communication abilities enable effective management of diverse teams, stakeholder relationships, and customer interactions while fostering collaborative culture and high-performance standards

Market Demand

Exceptionally high demand exists for experienced operations executives in medical device manufacturing, driven by industry expansion, regulatory complexity, and the specialized skill set required for cleanroom operations and FDA compliance. The combination of manufacturing leadership experience, regulatory expertise, and lean implementation capabilities creates a highly competitive candidate market with significant opportunities for career advancement and compensation growth.

Important Skills

Critical Skills

FDA QSR and ISO 13485 regulatory compliance expertise serves as fundamental requirement for success in medical device manufacturing, providing essential knowledge for maintaining market access, avoiding costly violations, and ensuring product safety standards that protect both patients and organizational reputation Lean manufacturing implementation and continuous improvement capabilities drive measurable operational excellence through systematic waste elimination, process optimization, and cultural transformation that directly impacts profitability, quality, and competitive positioning ERP system mastery and MRP functionality provide technological foundation for managing complex manufacturing operations, ensuring accurate inventory control, and maintaining real-time visibility into production performance and resource utilization P&L management and financial analysis skills enable effective resource allocation, cost optimization, and performance measurement that directly contribute to organizational success and executive credibility

Beneficial Skills

Defense and aerospace industry experience provides additional regulatory knowledge and quality system expertise that enhances candidate value and demonstrates ability to operate in multiple highly regulated environments Advanced project management capabilities including large-scale facility construction and equipment implementation provide valuable skills for managing complex capital projects and organizational growth initiatives International manufacturing experience and global supply chain knowledge offer strategic advantages as medical device companies increasingly expand into emerging markets and optimize global production networks

Unique Aspects

The combination of cleanroom management expertise and FDA regulatory compliance requirements creates a highly specialized role that demands unique technical knowledge and operational experience rarely found in general manufacturing environments
Full P&L accountability at the operations level provides exceptional visibility into business impact and strategic decision-making that accelerates executive development and demonstrates measurable value creation capabilities
The dual focus on high-mix low-volume and high-volume production requirements demands sophisticated operational flexibility and process optimization skills that differentiate this role from standard manufacturing leadership positions
Direct customer interface responsibilities including pricing negotiations and manufacturing agreements provide valuable commercial experience that enhances business acumen and market understanding

Career Growth

Career progression to C-suite or expanded VP roles typically occurs within 3-5 years for high-performing executives who demonstrate measurable operational improvements, successful major project implementations, and strong business results. Transition timeline depends on organizational growth, market conditions, and individual performance in driving transformational initiatives.

Potential Next Roles

Chief Operating Officer positions in mid to large-sized medical device companies where comprehensive operations experience and regulatory expertise provide competitive advantage for broader organizational leadership responsibilities Vice President of Manufacturing roles in Fortune 500 healthcare companies offering expanded scope including multiple facilities, international operations, and complex product portfolios requiring sophisticated operational coordination General Manager or Division President opportunities in specialized medical device segments where deep manufacturing knowledge combined with business development capabilities enable autonomous business unit leadership Consulting executive positions with premier strategy firms specializing in healthcare and manufacturing optimization where operational expertise and transformation experience provide valuable industry insights

Company Overview

Complete Staffing Jobs

Complete Staffing Jobs operates as a specialized recruitment and staffing firm focusing on technical and executive placements across manufacturing, engineering, and healthcare sectors. The organization maintains expertise in matching qualified candidates with complex roles requiring specialized technical knowledge and regulatory experience.

As a specialized staffing firm, the company occupies a niche position in the competitive recruitment market by focusing on technical and regulated industry placements where deep sector knowledge and candidate screening capabilities provide competitive differentiation from generalist staffing providers.
The Gardner, Massachusetts location positions the company within the broader New England manufacturing corridor, providing access to established medical device clusters, biotechnology companies, and advanced manufacturing facilities that create consistent demand for specialized talent acquisition services.
The staffing industry environment typically emphasizes relationship building, consultative approaches, and deep understanding of client needs and candidate capabilities. Professional culture likely values networking, industry expertise, and successful placement outcomes that create long-term client and candidate satisfaction.
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