Are you an experienced manufacturing leader with a strong background in the medical device industry? We are seeking a Manufacturing Manager (Medical Device) in San Jose, CA, to oversee production operations, ensure regulatory compliance, and drive efficiency in a fast-paced manufacturing environment. This role requires an expert in lean manufacturing, quality control, and process optimization who can lead teams, streamline production workflows, and maintain the highest industry standards.
As a Manufacturing Manager (Medical Device) in San Jose, CA, you will play a crucial role in managing end-to-end manufacturing processes, implementing continuous improvement strategies, and ensuring compliance with FDA and ISO regulations. If you have a track record of successfully leading manufacturing teams, enhancing productivity, and driving operational excellence in the medical device sector, we encourage you to apply.
About This Role
The Manufacturing Manager (Medical Device) in San Jose, CA is responsible for overseeing the entire production process, from raw material procurement to finished medical device products. This position requires a strategic thinker who can improve operational efficiencies, enforce quality control standards, and manage cross-functional teams, including engineering, quality assurance, and supply chain. The ideal candidate should possess a deep understanding of Good Manufacturing Practices (GMP), Six Sigma methodologies, and regulatory requirements in the medical device industry.
With a focus on cost-effective manufacturing, compliance, and innovation, the Manufacturing Manager (Medical Device) in San Jose, CA will develop and implement production strategies that support business growth while ensuring the highest quality and safety standards. This is an excellent opportunity for a results-driven manufacturing leader to make a significant impact on a growing medical device company.
Key Responsibilities – Manufacturing Manager (Medical Device) in San Jose, CA
Oversee Manufacturing Operations
- Manage day-to-day production activities, ensuring smooth operations and optimal workflow.
- Coordinate with cross-functional teams to meet production goals and deadlines.
- Monitor and improve manufacturing processes to enhance efficiency and reduce costs.
Ensure Regulatory Compliance
- Maintain compliance with FDA, ISO 13485, and GMP regulations in all manufacturing processes.
- Conduct regular audits and inspections to ensure adherence to quality and safety standards.
- Implement corrective and preventive actions (CAPA) to address any compliance issues.
Implement Lean Manufacturing & Process Optimization
- Utilize Lean, Six Sigma, and Kaizen methodologies to improve production efficiency.
- Reduce waste, enhance productivity, and optimize resource utilization.
- Develop and refine standard operating procedures (SOPs) for enhanced workflow.
Manage Quality Assurance & Control
- Oversee quality control initiatives to maintain product integrity and consistency.
- Collaborate with the quality team to implement testing protocols and defect reduction strategies.
- Ensure all products meet regulatory and company quality standards before distribution.
Lead & Develop Manufacturing Teams
- Hire, train, and mentor production staff to enhance performance and skill development.
- Foster a culture of continuous improvement, teamwork, and accountability.
- Implement employee training programs to enhance technical expertise and compliance awareness.
Monitor Production Metrics & Performance
- Establish and track KPIs related to manufacturing efficiency, defect rates, and production output.
- Analyze performance data to identify trends and areas for improvement.
- Provide detailed reports to senior management on production performance and operational effectiveness.
Coordinate Supply Chain & Inventory Management
- Collaborate with supply chain teams to ensure timely procurement of raw materials and components.
- Optimize inventory levels to prevent shortages or excess stock.
- Work closely with vendors and suppliers to improve lead times and cost efficiency.
Drive Innovation & Continuous Improvement
- Identify and implement new manufacturing technologies and automation solutions.
- Stay updated with industry advancements to enhance production capabilities.
- Lead initiatives to introduce new product lines while maintaining high manufacturing standards.
What The Client is Looking For in You
To excel as the Manufacturing Manager (Medical Device) in San Jose, CA, you should bring a combination of strong leadership skills, deep industry expertise, and a commitment to continuous improvement. The ideal candidate will possess:
- Extensive Manufacturing Experience in the Medical Device Industry – A strong background in managing medical device production, including knowledge of FDA and ISO 13485 regulations, quality control, and process optimization.
- Proven Leadership and Team Management Abilities – Experience leading, training, and developing manufacturing teams to achieve high performance and operational excellence.
- Strong Understanding of Lean Manufacturing & Continuous Improvement – A track record of implementing Six Sigma, Kaizen, or other lean methodologies to drive efficiency and reduce waste.
- Regulatory Compliance Expertise – In-depth knowledge of Good Manufacturing Practices (GMP), risk management protocols, and industry regulations to maintain compliance.
- Data-Driven & Results-Oriented Approach – The ability to analyze production metrics, identify inefficiencies, and implement solutions that improve manufacturing performance.
- Cross-Functional Collaboration Skills – Experience working with engineering, quality assurance, supply chain, and executive leadership to align production goals with business objectives.
- Technical & Process Improvement Knowledge – Proficiency in manufacturing technologies, automation, and process optimization to enhance production capabilities.
- Problem-Solving & Strategic Thinking – The ability to anticipate challenges, troubleshoot issues, and implement long-term solutions to improve production efficiency.
If you are a driven and innovative professional with a passion for optimizing manufacturing operations in the medical device industry, this role offers the perfect opportunity for you to make a lasting impact.
Why This Opportunity Stands Out
This role offers a unique opportunity to be a key player in a growing medical device company. As the Manufacturing Manager (Medical Device) in San Jose, CA, you will:
- Lead Manufacturing Excellence – Take charge of a dynamic production environment and implement world-class manufacturing processes.
- Work with Cutting-Edge Medical Device Technology – Be part of a company that develops and produces innovative medical devices that improve patient outcomes.
- Competitive Compensation & Benefits – Enjoy a strong salary package, performance incentives, and executive-level benefits.
- Be at the Forefront of Industry Innovation – Drive improvements in automation, lean manufacturing, and regulatory compliance in a forward-thinking company.
- Collaborate with a High-Performing Leadership Team – Work closely with executive leadership and cross-functional teams to shape manufacturing strategies and ensure operational success.
- Career Growth & Development – Benefit from professional growth opportunities, leadership development programs, and industry networking.
- Strong Company Culture & Supportive Work Environment – Join a company that values collaboration, innovation, and excellence in medical device manufacturing.
If you are looking for a leadership role that allows you to drive meaningful change and be part of a company that is transforming medical device manufacturing, this is the opportunity for you!
FAQs About the Role
Q: What industries should I have experience in?
A: You should have a strong background in the medical device industry, particularly in manufacturing, production management, and regulatory compliance. Experience with FDA and ISO 13485 requirements is essential.
Q: What is the preferred location for this role?
A: The role is based in San Jose, CA. Candidates must be open to relocation or already reside in the area.
Q: What are the key responsibilities of the Manufacturing Manager?
A: This role involves overseeing production operations, ensuring regulatory compliance, optimizing manufacturing processes, managing teams, and improving efficiency in a medical device manufacturing environment.
Q: What kind of leadership style is expected?
A: We seek a hands-on, results-driven, and strategic leader who can foster a culture of continuous improvement, teamwork, and operational excellence.
Q: What qualifications and skills are required?
A: Candidates should have a bachelor’s or master’s degree in engineering, manufacturing, or a related field, along with 8+ years of leadership experience in medical device manufacturing. Lean Six Sigma certification and experience with automation and process improvement are a plus.
Q: What is the expected travel requirement?
A: Minimal travel is required, though occasional visits to vendors, suppliers, or industry conferences may be necessary.
Q: How does this role contribute to the company’s overall success?
A: The Manufacturing Manager (Medical Device) in San Jose, CA plays a critical role in driving operational efficiency, maintaining product quality, ensuring regulatory compliance, and supporting business growth.
Q: What is the hiring timeline?
A: The company aims to complete the hiring process within the next 60–90 days. The onboarding process will include manufacturing strategy sessions, process audits, and leadership alignment meetings to ensure a smooth transition into the role.
What Remuneration Can You Expect from This Job?
As the Manufacturing Manager (Medical Device) in San Jose, CA, you can expect a competitive salary and benefits package aligned with industry standards for leadership roles in medical device manufacturing. Compensation for this position is based on experience, qualifications, and the ability to drive operational excellence, with a base salary typically ranging from $130,000 to $160,000 per year, plus performance-based incentives.
In addition to a strong salary, this role offers a comprehensive benefits package, including:
- Annual Performance Bonuses – Based on key performance indicators (KPIs) such as efficiency improvements, cost savings, and production targets.
- Health, Dental, and Vision Insurance – Comprehensive coverage for employees and their families.
- Retirement Plans (401k with Company Match) – Secure your financial future with competitive retirement benefits.
- Paid Time Off (PTO) & Holidays – Generous leave policies to support work-life balance.
- Professional Development & Training – Opportunities for leadership training, certifications, and industry conference participation.
- Relocation Assistance (If Applicable) – For qualified candidates willing to move to San Jose, CA.
This role provides a financially rewarding opportunity for a results-driven manufacturing leader who is looking to make a significant impact in the medical device industry.
How to Apply for This Manufacturing Manager (Medical Device) Position in San Jose, CA
If you are an experienced manufacturing leader with a strong background in medical device production, process optimization, and regulatory compliance, we encourage you to apply for the Manufacturing Manager (Medical Device) in San Jose, CA position. This is an excellent opportunity to lead high-performing teams, drive operational efficiency, and ensure regulatory adherence in a cutting-edge medical device company.
To apply, please submit your resume and a cover letter detailing your expertise in lean manufacturing, process improvement, quality control, and leadership within the medical device sector.
This role offers a rewarding opportunity to contribute to a company that is pioneering innovation in medical device manufacturing. Apply today to take the next step in your career as a Manufacturing Manager (Medical Device) in San Jose, CA!
For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.
Tags: Manufacturing Manager | Medical Device Manufacturing | Lean Manufacturing | Quality Assurance | Process Optimization | FDA Compliance | Production Leadership
