Are you an innovative leader with a passion for advancing biomedical technology? We are seeking a Director of Biomedical Engineering to spearhead research, development, and implementation of cutting-edge biomedical solutions. This executive role demands a highly skilled professional with expertise in medical device innovation, regulatory compliance, and engineering leadership. The Director of Biomedical Engineering will play a pivotal role in leading cross-functional teams, optimizing product development processes, and ensuring that biomedical technologies meet the highest industry standards.
As the Director of Biomedical Engineering, you will be responsible for managing the full lifecycle of biomedical projects—from concept to commercialization. You will collaborate with R&D, regulatory teams, and healthcare professionals to drive innovation while ensuring compliance with FDA and ISO standards. If you have a track record of success in biomedical engineering, a passion for medical technology, and the leadership skills to guide a high-performing engineering team, we want to hear from you.
About This Role
The Director of Biomedical Engineering is a strategic leadership position focused on driving innovation in medical technology and ensuring the successful development of biomedical devices and systems. This role requires a deep understanding of biomedical engineering principles, regulatory requirements, and emerging industry trends. The Director of Biomedical Engineering will oversee research and development, design validation, quality assurance, and product lifecycle management while ensuring alignment with business goals and healthcare regulations.
This role presents an exciting opportunity to lead a dynamic engineering team, collaborate with cross-functional departments, and drive groundbreaking advancements in medical technology. The Director of Biomedical Engineering will work closely with healthcare providers, regulatory agencies, and industry leaders to ensure that biomedical products are safe, effective, and commercially viable. If you are a results-driven engineering professional with a passion for improving healthcare through innovation, this position offers a unique platform to make a significant impact.
Key Responsibilities – Director of Biomedical Engineering
1. Lead Biomedical Research & Development
- Oversee the design, development, and testing of biomedical devices and systems.
- Ensure that R&D initiatives align with industry trends, technological advancements, and regulatory standards.
- Foster innovation by identifying new opportunities for product development and process improvement.
2. Manage Product Lifecycle & Engineering Processes
- Oversee the entire product lifecycle, from concept development to commercialization.
- Implement best practices in engineering design, validation, and verification processes.
- Ensure timely execution of projects while maintaining quality and cost-effectiveness.
3. Ensure Compliance with Regulatory Standards
- Develop and implement strategies to comply with FDA, ISO, and other global regulatory requirements.
- Work closely with regulatory teams to obtain necessary approvals for biomedical products.
- Maintain thorough documentation and quality control processes to ensure compliance.
4. Lead Cross-Functional Collaboration
- Coordinate with R&D, manufacturing, marketing, and sales teams to align engineering efforts with business goals.
- Partner with clinical experts, hospitals, and healthcare professionals to integrate user feedback into product development.
- Foster a collaborative culture that encourages innovation and knowledge sharing.
5. Drive Innovation in Biomedical Technology
- Identify emerging trends and technologies in biomedical engineering.
- Explore and implement advancements in AI, machine learning, and robotics for medical applications.
- Develop strategies to enhance the performance, safety, and efficiency of medical devices.
6. Oversee Budgeting & Resource Allocation
- Manage departmental budgets, ensuring efficient allocation of resources for R&D initiatives.
- Assess financial feasibility of new projects and provide recommendations to leadership.
- Optimize cost-effectiveness in engineering operations without compromising quality.
7. Develop & Mentor Engineering Teams
- Recruit, train, and mentor a team of biomedical engineers and technical specialists.
- Establish a culture of continuous learning, professional development, and technical excellence.
- Implement performance evaluation systems to enhance team productivity and effectiveness.
8. Represent the Organization in Industry & Regulatory Forums
- Act as the key representative in biomedical engineering conferences, industry events, and regulatory discussions.
- Engage with industry stakeholders to foster partnerships and collaborations.
- Provide thought leadership on emerging trends, challenges, and advancements in biomedical engineering.
What The Client is Looking For in You
To succeed as the Director of Biomedical Engineering, you should bring a combination of technical expertise, leadership acumen, and strategic vision. The ideal candidate will possess:
- Extensive Experience in Biomedical Engineering – A strong background in biomedical device development, engineering management, and regulatory compliance. Prior leadership experience in medical device companies or healthcare technology firms is highly preferred.
- Deep Understanding of Medical Device Regulations – Knowledge of FDA, ISO 13485, and other global regulatory frameworks to ensure compliance throughout the product development lifecycle.
- Proven Leadership & Team Development Skills – Ability to mentor, develop, and inspire engineering teams while fostering a culture of innovation and excellence.
- Strategic and Analytical Thinking – Strong ability to analyze market trends, technological advancements, and regulatory changes to inform business decisions.
- Project Management & Execution Excellence – A track record of successfully managing complex engineering projects from ideation to commercialization, ensuring quality, safety, and cost-effectiveness.
- Innovation-Driven Mindset – Passion for cutting-edge medical technologies, emerging trends in healthcare engineering, and improving patient outcomes through innovation.
- Strong Communication & Cross-Functional Collaboration – Ability to engage with executives, R&D teams, regulatory bodies, and healthcare professionals to align engineering efforts with business objectives.
- Financial Acumen & Budgeting Skills – Experience managing budgets, resource allocation, and cost optimization for biomedical research and development initiatives.
If you are a results-oriented leader with a passion for medical technology, this role provides an exciting opportunity to drive meaningful advancements in healthcare solutions.
Why This Opportunity Stands Out
This role as the Director of Biomedical Engineering offers a unique and rewarding career opportunity. Here’s why this position is a game-changer:
- Lead Cutting-Edge Biomedical Innovation – Spearhead the development of next-generation medical devices and healthcare solutions that improve patient care and treatment outcomes.
- Executive-Level Impact & Strategic Leadership – Play a pivotal role in shaping the company’s engineering strategy and driving product innovation.
- Collaborate with Industry Leaders – Work alongside top executives, scientists, and regulatory experts to influence the future of biomedical engineering.
- Competitive Compensation & Benefits – Enjoy a highly competitive salary, performance-based bonuses, equity options, and a comprehensive benefits package.
- A Culture of Innovation & Growth – Join an organization that fosters creativity, continuous learning, and a commitment to pushing the boundaries of medical technology.
- Opportunities for Global Market Expansion – Be part of an organization that is expanding its footprint internationally, offering new challenges and professional growth opportunities.
- Make a Meaningful Impact – Contribute to the development of life-changing medical technologies that improve healthcare outcomes and enhance patient quality of life.
This position is ideal for a forward-thinking biomedical engineering leader who wants to take their career to the next level while making a significant impact on the medical technology industry.
FAQs About the Role
Q: What industries should I have experience in?
A: You should have a strong background in biomedical engineering, medical devices, or healthcare technology. Experience in R&D, regulatory compliance, and product development is highly preferred.
Q: Is relocation required for this position?
A: The role is based in Irvine, CA. 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 Biomedical Engineering will report directly to the Chief Technology Officer (CTO) and collaborate closely with the executive leadership team.
Q: What kind of leadership style is expected?
A: We seek a hands-on, strategic, and innovation-driven leader who can inspire teams, drive product development, and ensure regulatory compliance while fostering a culture of excellence.
Q: What are the expected travel requirements?
A: This role may require some domestic and international travel for industry conferences, regulatory meetings, and collaboration with research institutions.
Q: What qualifications and skills are required?
A: Candidates should have a bachelor’s or master’s degree in Biomedical Engineering, Mechanical Engineering, or a related field. A Ph.D. is a plus. At least 10+ years of experience in biomedical engineering leadership, product development, and regulatory compliance are required.
Q: How does this role contribute to the company’s success?
A: The Director of Biomedical Engineering is responsible for leading innovation, ensuring regulatory compliance, and developing state-of-the-art medical devices that drive business growth and improve patient care.
Q: What is the hiring timeline for this role?
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 strategy meetings, deep dives into current R&D projects, and alignment on innovation goals.
What Remuneration Can You Expect from This Job?
As the Director of Biomedical Engineering, you can expect a highly competitive compensation package that reflects the critical nature of this leadership role. The base salary typically ranges between $180,000 – $250,000 per year, depending on your experience, expertise in biomedical engineering, and prior success in leading engineering teams.
Beyond the base salary, this role offers performance-based bonuses and incentives tied to key metrics such as successful product development, regulatory approvals, and market impact. For highly qualified candidates, equity options or stock grants may be included, allowing you 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, and generous paid time off (PTO). Additional perks may include relocation assistance, travel allowances, and professional development opportunities, such as industry conferences and certifications.
This role provides not only a lucrative financial package but also an opportunity to drive groundbreaking biomedical innovations that improve patient care worldwide. If you are a visionary leader looking to make a lasting impact in the biomedical field, this position offers the perfect platform for success.
How to Apply for This Director of Biomedical Engineering Position
If you are a strategic and results-driven leader with a proven track record in biomedical engineering, we invite you to apply for the Director of Biomedical Engineering position. This is an exceptional opportunity to lead cutting-edge innovation and shape the future of medical technology.
To apply, please submit your resume and a cover letter detailing your experience in biomedical engineering leadership, product development, regulatory compliance, and technology innovation.
This role offers a unique chance to work at the forefront of medical device advancements, lead high-impact engineering teams, and drive meaningful change in the healthcare industry. Apply today to take the next step in your career as a Director of Biomedical Engineering!
For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.
Director of Biomedical Engineering | Biomedical Engineering Leadership | Medical Device Engineering | Healthcare Technology | R&D Executive | Regulatory Compliance
