Are you an experienced operations leader with a strong background in the medical device industry? We are looking for an Operations Manager (Med Device) in Irvine, CA, to join a growing team in a dynamic and fast-paced environment. As an integral part of the operations team, this role offers the opportunity to drive efficiency, improve processes, and contribute to the success of the organization. If you are ready to take on new challenges and elevate your career in a critical role within the medical device sector, this position is for you.
About This Role:
The Operations Manager (Med Device) in Irvine, CA, will play a vital role in overseeing and optimizing the daily operations within the medical device manufacturing process. This position requires a hands-on leader who will manage the production, quality control, and logistics aspects of the business, ensuring compliance with regulatory standards and driving operational improvements. The ideal candidate will possess strong project management skills, a keen eye for detail, and the ability to collaborate effectively with cross-functional teams. In this role, you will have a significant impact on the organization’s operational success and contribute to the continuous improvement of processes.
Key Responsibilities – Operations Manager (Med Device) in Irvine, CA:
Oversee Daily Operations
- Manage daily operations in the production facility, ensuring smooth workflows and efficient use of resources.
- Collaborate with department heads to align production goals and objectives with business strategies.
- Troubleshoot and resolve any operational issues to maintain production timelines.
Ensure Compliance with Regulatory Standards
- Monitor compliance with FDA, ISO, and other relevant regulatory standards for manufacturing processes.
- Work closely with the quality assurance team to ensure all products meet industry and regulatory requirements.
- Stay updated on changes in regulatory guidelines and incorporate them into company practices.
Implement Operational Improvements
- Identify areas for improvement in operational efficiency, implementing best practices and lean methodologies.
- Analyze production data to identify inefficiencies and develop corrective actions.
- Develop and implement strategies to streamline processes, reduce costs, and improve product quality.
Manage Production Planning and Scheduling
- Oversee production planning and scheduling, ensuring on-time delivery and efficient use of resources.
- Coordinate with supply chain and logistics teams to ensure adequate materials are available for production.
- Ensure proper inventory management to prevent production delays.
Lead and Develop Team Members
- Lead a team of production staff, providing coaching and guidance to ensure optimal performance.
- Implement training programs to ensure employees are up-to-date on best practices and safety protocols.
- Foster a positive, collaborative, and high-performance culture within the operations team.
Collaborate with Cross-Functional Teams
- Work closely with R&D, quality, and engineering teams to support product development and production.
- Ensure effective communication between departments to support smooth operational processes.
- Participate in cross-functional meetings to address operational challenges and implement solutions.
Monitor Key Performance Indicators (KPIs)
- Track and report on key performance indicators (KPIs) related to production efficiency, quality, and safety.
- Use data and analytics to drive decision-making and improvements in operations.
- Provide regular updates to senior management on operational performance and initiatives.
Manage Supply Chain and Inventory Control
- Oversee inventory management and collaborate with the supply chain team to ensure product availability.
- Monitor stock levels to prevent shortages or excess inventory, optimizing storage costs.
- Work closely with vendors and suppliers to maintain timely deliveries and manage vendor relationships.
This role offers an exciting opportunity to lead operations in a fast-paced, innovative environment where you can make a lasting impact on both the company’s success and your own professional development.
What The Client is Looking For in You
To succeed as the Operations Manager (Med Device) in Irvine, CA, you should bring a blend of leadership, industry expertise, and a commitment to operational excellence. The ideal candidate will possess:
- Experience in Medical Device Manufacturing – Strong background in medical device production, quality control, and regulatory compliance.
- Leadership Skills – Proven track record in managing and mentoring teams, fostering a collaborative and performance-driven environment.
- Process Improvement Expertise – Expertise in identifying operational inefficiencies and implementing process improvements using methodologies like Lean or Six Sigma.
- Knowledge of Regulatory Standards – In-depth understanding of FDA, ISO, and other industry regulations as they pertain to medical device manufacturing.
- Project Management – Strong project management skills with the ability to handle multiple projects simultaneously and meet deadlines.
- Analytical Abilities – Comfortable working with data and KPIs to drive decisions and optimize operational efficiency.
- Excellent Communication Skills – Able to effectively communicate across departments, with vendors, and with senior leadership.
- Commitment to Quality – Focus on maintaining the highest standards of product quality and operational safety.
Why This Opportunity Stands Out
This position as Operations Manager (Med Device) in Irvine, CA, offers an exciting opportunity to play a pivotal role in a growing medical device company. As part of this innovative organization, you will:
- Lead Operational Excellence – Drive continuous improvement and streamline operations to meet company goals and regulatory standards.
- Work in a High-Growth Environment – Be part of a rapidly expanding industry with opportunities for career development and growth.
- Make an Impact on Healthcare – Contribute to the success of products that directly impact patient outcomes and healthcare advancements.
- Competitive Compensation – Receive a competitive salary, performance bonuses, and a comprehensive benefits package.
- Work with Industry Leaders – Collaborate with experienced professionals in a dynamic and supportive environment.
- Comprehensive Training and Development – Take advantage of professional development programs and the chance to further your expertise in the medical device industry.
FAQs About the Role
Q: Is relocation required for this position?
A: Yes, this role is based in Irvine, CA. Candidates must either be local or willing to relocate. A relocation package may be available for the right candidate.
Q: What kind of experience is needed for this position?
A: The ideal candidate should have 5+ years of experience in operations management within the medical device industry, with a focus on manufacturing, quality assurance, and regulatory compliance.
Q: What is the reporting structure for this role?
A: The Operations Manager (Med Device) in Irvine, CA, will report directly to the Vice President of Operations and collaborate closely with other senior leaders in the organization.
Q: What is the expected travel requirement for this role?
A: This role may require limited travel for vendor meetings, industry conferences, or plant visits, but most responsibilities will be based in Irvine, CA.
Q: What qualifications are required for this role?
A: A bachelor’s degree in operations management, engineering, business, or a related field is required. Certifications in Lean, Six Sigma, or project management are a plus.
Q: What is the impact of this role on the company’s success?
A: As the Operations Manager (Med Device) in Irvine, CA, you will be instrumental in optimizing production processes, ensuring regulatory compliance, and driving continuous improvement to meet business goals and contribute to overall success.
Q: What are the growth opportunities within this role?
A: There is strong potential for career growth in this role, with opportunities to advance into senior leadership positions as the company expands and new opportunities arise in the medical device sector.
Q: How soon do you expect to hire for this role?
A: The company is looking to fill this role within the next 60–90 days. The hiring process will involve multiple interviews, and onboarding will include training on the company’s operations and processes.
What Remuneration Can You Expect from This Job?
As the Operations Manager (Med Device) in Irvine, CA, you can expect a competitive compensation package that reflects your expertise in the medical device industry and your leadership abilities. The base salary for this position typically ranges from $100,000 to $130,000 per year, depending on experience, qualifications, and industry knowledge. In addition to the base salary, the role offers performance-based bonuses and incentives tied to operational efficiency, cost savings, and overall company performance.
Beyond salary, the comprehensive benefits package includes medical, dental, and vision coverage, a 401(k) retirement plan with company matching, paid time off (PTO), and holiday leave. You will also have access to professional development opportunities, ensuring your continued growth in the medical device sector. Additional benefits may include relocation assistance (if applicable), flexible work arrangements, and participation in industry conferences.
This role offers not only a rewarding salary and benefits package but also an exciting opportunity to grow your career in a fast-paced and dynamic industry that directly impacts healthcare and patient outcomes.
How to Apply for This Operations Manager (Med Device) Position in Irvine, CA
If you are an experienced operations professional with a background in the medical device industry, we invite you to apply for the Operations Manager (Med Device) position in Irvine, CA. This is an excellent opportunity to contribute to a rapidly growing company while making a meaningful impact on healthcare products.
To apply, please submit your resume and a cover letter outlining your experience in operations management, process improvement, and regulatory compliance within the medical device sector.
This role offers a great chance to join a dynamic team and make a direct impact on the company’s operations and growth. Apply today to take the next step in your career as an Operations Manager (Med Device) in Irvine, CA!
For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.
Tags: Operations Manager | Medical Device Operations | Manufacturing Management | Process Improvement | Regulatory Compliance
