Are you an experienced manufacturing leader with a passion for driving operational excellence in the medical device industry? We are seeking a Director of Manufacturing (Medical Device) in Boston, MA to oversee production processes, ensure regulatory compliance, and implement strategies that optimize efficiency and quality. This leadership role is ideal for a results-driven professional with a proven track record in manufacturing operations, lean methodologies, and process improvement within the medical device sector.

As the Director of Manufacturing (Medical Device) in Boston, MA, you will be responsible for leading production teams, enhancing supply chain processes, and ensuring the highest standards of quality and compliance in manufacturing operations. If you have extensive experience in medical device manufacturing and a strong ability to streamline production while maintaining strict adherence to FDA and ISO standards, we want to hear from you.

About This Role

The Director of Manufacturing (Medical Device) in Boston, MA plays a critical role in overseeing end-to-end manufacturing operations, ensuring product quality, and driving continuous improvement initiatives. This position requires a strategic leader who can optimize manufacturing workflows, implement lean manufacturing principles, and collaborate with cross-functional teams to achieve business objectives.

This role will focus on enhancing operational efficiencies, maintaining compliance with industry regulations, and driving cost-effective production strategies. The Director of Manufacturing (Medical Device) in Boston, MA will be at the forefront of leading innovative manufacturing practices, ensuring scalability, and supporting the company’s long-term growth. If you are a manufacturing expert with a deep understanding of medical device production and are looking for an opportunity to make a significant impact, this is the role for you.

Key Responsibilities – Director of Manufacturing (Medical Device) in Boston, MA

Oversee Manufacturing Operations

Manage and oversee all aspects of the medical device manufacturing process, ensuring efficient production.
Develop and implement operational strategies that align with business objectives.
Monitor and optimize production workflows to enhance efficiency and reduce waste.

Ensure Regulatory Compliance

Maintain strict adherence to FDA, ISO 13485, and other regulatory requirements.
Implement and oversee quality control procedures to ensure product safety and compliance.
Collaborate with regulatory teams to ensure all documentation and processes meet industry standards.

Lead Process Improvement Initiatives

Implement lean manufacturing and Six Sigma methodologies to drive continuous improvement.
Identify opportunities for process optimization, reducing production costs while maintaining quality.
Develop strategies to enhance product consistency, reliability, and scalability.

Manage Supply Chain and Inventory Control

Oversee supply chain operations, ensuring seamless procurement of raw materials.
Optimize inventory levels to balance cost-effectiveness with production demands.
Work closely with vendors and suppliers to maintain high-quality standards and timely deliveries.

Enhance Production Quality and Efficiency

Develop and enforce strict quality assurance programs across manufacturing processes.
Conduct regular audits and inspections to ensure compliance with quality standards.
Utilize data analytics to track performance and implement corrective actions as needed.

Lead and Develop Manufacturing Teams

Build and manage high-performing teams across production and quality control departments.
Provide leadership, mentorship, and training programs to enhance team capabilities.
Foster a culture of collaboration, innovation, and continuous learning.

Drive Cost Reduction and Budget Optimization

Develop and manage manufacturing budgets, ensuring cost-effectiveness without compromising quality.
Identify and implement cost-saving measures across production processes.
Evaluate and negotiate contracts with suppliers and vendors for maximum efficiency.

Implement Advanced Manufacturing Technologies

Stay up to date with the latest advancements in medical device manufacturing.
Introduce automation and cutting-edge technologies to enhance production capabilities.
Ensure integration of digital and data-driven solutions for process monitoring and optimization.

What The Client is Looking For in You

To excel as the Director of Manufacturing (Medical Device) in Boston, MA, you should bring a combination of strategic leadership, technical expertise, and a results-driven mindset. The ideal candidate will possess:

Extensive Experience in Medical Device Manufacturing – A strong background in overseeing large-scale manufacturing operations in a highly regulated environment, ensuring compliance with FDA, ISO 13485, and other industry standards.
Proven Leadership and Team Management Skills – Experience managing and developing high-performing teams, fostering a culture of collaboration, accountability, and continuous improvement.
Expertise in Lean Manufacturing and Process Optimization – A deep understanding of lean principles, Six Sigma methodologies, and other process improvement techniques to drive operational efficiency.
Strong Regulatory and Quality Assurance Knowledge – Ability to navigate regulatory requirements, quality control measures, and risk management processes to maintain compliance and product integrity.
Supply Chain and Inventory Management Expertise – Skilled in optimizing supply chain operations, vendor negotiations, and cost-effective inventory control to ensure seamless production.
Technical and Analytical Acumen – Capability to leverage data analytics, automation, and cutting-edge manufacturing technologies to enhance production efficiency and scalability.
Strategic Thinking and Business Acumen – A results-oriented leader who can align manufacturing operations with company goals, driving cost reduction, revenue growth, and operational excellence.
Commitment to Innovation and Continuous Improvement – A forward-thinking mindset, embracing new manufacturing techniques and emerging industry trends to maintain a competitive edge.

Why This Opportunity Stands Out

This role offers a unique opportunity to be a key player in the medical device industry, driving the future of manufacturing excellence. As the Director of Manufacturing (Medical Device) in Boston, MA, you will:

Lead a Cutting-Edge Manufacturing Operation – Take charge of a state-of-the-art manufacturing facility, implementing the latest technologies and process innovations.
Make a Meaningful Impact on Healthcare – Play a pivotal role in ensuring the production of high-quality medical devices that improve patient outcomes worldwide.
Competitive Compensation & Executive Benefits – Enjoy a lucrative salary, performance-based bonuses, and comprehensive benefits tailored for top-tier leadership.
Strategic Leadership Role – Work closely with executive leadership to define the company’s manufacturing strategy and long-term vision.
Drive Industry Innovation – Be at the forefront of implementing next-generation manufacturing techniques, automation, and lean methodologies.
Collaborate with Cross-Functional Teams – Engage with R&D, quality assurance, regulatory, and supply chain teams to enhance production efficiency and compliance.
Growth & Career Advancement – Join a rapidly expanding company with opportunities for career growth and professional development in an evolving industry.

FAQs About the Role

Q: What industries should I have experience in?
A: You should have extensive experience in medical device manufacturing, including knowledge of FDA, ISO 13485, and other regulatory requirements. Experience in lean manufacturing, Six Sigma, and process improvement is highly preferred.

Q: Is relocation required for this position?
A: This role is based in Boston, MA. Candidates must be open to relocation or already reside in the area. Relocation assistance may be available for the right candidate.

Q: What is the reporting structure for this role?
A: The Director of Manufacturing (Medical Device) in Boston, MA will report directly to the VP of Operations and collaborate with executive leadership, including R&D, Quality, and Supply Chain teams.

Q: What qualifications and skills are required?
A: A bachelor’s or master’s degree in engineering, manufacturing, operations management, or a related field is required. Candidates should have at least 10+ years of leadership experience in medical device manufacturing with expertise in lean principles, compliance, and operational excellence.

Q: What is the expected travel requirement?
A: This role may require occasional travel for supplier visits, industry conferences, and multi-site manufacturing operations.

Q: What leadership style is expected?
A: We are looking for a hands-on leader who is strategic, results-driven, and highly collaborative. You should have a strong ability to lead teams, drive process improvements, and ensure compliance in a high-growth manufacturing environment.

Q: How does this role contribute to the company’s overall success?
A: The Director of Manufacturing (Medical Device) in Boston, MA plays a critical role in optimizing production, maintaining regulatory compliance, reducing costs, and ensuring high-quality medical devices reach the market efficiently.

Q: What is the timeline for hiring and onboarding?
A: The company is actively seeking the right candidate and aims to complete the hiring process within the next 60–90 days. Onboarding will include training on company processes, regulatory compliance procedures, and strategy alignment with executive leadership.

What Remuneration Can You Expect from This Job?

As the Director of Manufacturing (Medical Device) in Boston, MA, you can expect a highly competitive compensation package that reflects your leadership role and the impact you will have on the company’s manufacturing operations. The base salary for this position typically ranges from $180,000 to $230,000 per year, depending on your experience, industry expertise, and proven track record in optimizing medical device manufacturing processes.

In addition to the base salary, this role includes performance-based bonuses and incentives tied to key operational and financial metrics, such as production efficiency, cost savings, and regulatory compliance. Equity options or stock grants may also be available, providing an opportunity to share in the company’s long-term success.

The benefits package includes comprehensive healthcare coverage (medical, dental, and vision), a 401(k) retirement plan with company matching, executive-level perks, paid time off, and professional development opportunities. Additional benefits may include relocation assistance, annual bonuses, travel allowances, and participation in industry conferences and leadership programs.

This role not only offers a lucrative financial package but also a career-defining opportunity to lead a cutting-edge manufacturing operation and drive impactful innovations in the medical device industry.

How to Apply for This Director of Manufacturing (Medical Device) Position in Boston, MA

If you are a strategic leader with a proven track record in medical device manufacturing, we invite you to apply for the Director of Manufacturing (Medical Device) in Boston, MA. This is a unique opportunity to lead high-performance manufacturing operations, ensure compliance, and drive continuous process improvements in a growing organization.

To apply, please submit your resume and a cover letter detailing your experience in manufacturing leadership, regulatory compliance, process optimization, and operational efficiency in the medical device sector.

This role offers an exciting chance to work with an innovative company at the forefront of medical technology. Apply today to take the next step in your manufacturing leadership career as the Director of Manufacturing (Medical Device) in Boston, MA!

For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.

Tags:

Job Category: Director of Manufacturing

Job Type: Full Time

Job Location: Boston

Director of Manufacturing (Medical Device) in Boston, MA