Are you a pioneering leader in medical device research and development with a passion for driving innovation? We are seeking a Director of R and D (Medical Device) in Boston, MA, to lead breakthrough developments in medical technology, oversee cutting-edge product innovation, and manage a high-performing R&D team. This executive position requires a strategic thinker with extensive experience in product development, regulatory compliance, and technology commercialization within the medical device sector.
As the Director of R and D (Medical Device) in Boston, MA, you will be responsible for guiding R&D strategy, ensuring compliance with FDA and ISO regulations, and accelerating product pipelines to improve patient outcomes. If you thrive in leading multidisciplinary teams and transforming innovative concepts into market-ready solutions, this is an exciting opportunity to make a significant impact in the medical technology landscape.
About This Role
The Director of R and D (Medical Device) in Boston, MA plays a critical role in shaping the company’s innovation roadmap, leading R&D programs, and ensuring seamless coordination between engineering, regulatory affairs, and manufacturing teams. This position demands a deep understanding of emerging medical technologies, risk assessment, and design control processes to drive groundbreaking product developments.
As a key member of the leadership team, the Director of R and D (Medical Device) in Boston, MA will spearhead R&D strategies, mentor a team of engineers and scientists, and establish industry collaborations to enhance technological advancements. With a focus on developing safe, effective, and compliant medical devices, this role offers the opportunity to work on life-changing innovations while ensuring regulatory success and market competitiveness.
Key Responsibilities – Director of R and D (Medical Device) in Boston, MA
Lead R&D Strategy and Innovation
- Define and implement long-term R&D strategies to advance product development and technological innovation.
- Stay ahead of industry trends, emerging medical technologies, and competitive market dynamics.
- Foster a culture of innovation, collaboration, and scientific excellence within the R&D team.
Oversee Product Development Lifecycle
- Manage the full product development cycle, from concept ideation to commercialization.
- Ensure that all products meet design, usability, and safety standards while adhering to regulatory guidelines.
- Collaborate with engineering, clinical, and regulatory teams to ensure timely product launches.
Ensure Regulatory Compliance and Risk Management
- Lead regulatory strategy for new product development, ensuring compliance with FDA, ISO, and CE standards.
- Oversee risk assessments, design control processes, and validation testing for medical devices.
- Work closely with regulatory affairs teams to facilitate 510(k), PMA, and CE Mark submissions.
Drive Cross-Functional Collaboration
- Act as a bridge between R&D, manufacturing, marketing, and clinical affairs to streamline product development.
- Work with key opinion leaders (KOLs), research institutions, and industry partners to enhance R&D efforts.
- Align R&D goals with business objectives to support corporate growth and market expansion.
Optimize Technology and Process Development
- Identify new materials, technologies, and design methodologies to enhance product innovation.
- Implement best practices in R&D project management, lean development, and cost-effective design.
- Drive the adoption of AI, automation, and digital health solutions in medical device development.
Mentor and Lead High-Performing Teams
- Build, manage, and mentor a multidisciplinary R&D team, fostering talent development and technical excellence.
- Encourage a culture of continuous learning, experimentation, and innovation.
- Establish performance metrics to track R&D progress, efficiency, and impact on product development.
Oversee Clinical and Preclinical Research Initiatives
- Guide preclinical and clinical research studies to validate the safety and efficacy of new medical devices.
- Develop clinical study protocols, work with CROs, and liaise with regulatory agencies on study approvals.
- Analyze clinical data to support regulatory submissions and market entry strategies.
Drive Intellectual Property (IP) and Patent Strategy
- Identify and protect intellectual property through patents, trade secrets, and licensing agreements.
- Collaborate with legal teams to manage patent filings and safeguard proprietary technologies.
- Evaluate competitive patents to strengthen the company’s IP portfolio and maintain a market edge.
What The Client is Looking For in You
To succeed as the Director of R and D (Medical Device) in Boston, MA, you should be a strategic and hands-on leader with a strong background in medical device research, development, and commercialization. The ideal candidate will bring technical expertise, regulatory knowledge, and leadership skills to drive innovation and product success.
Key Qualifications & Skills
- Extensive Experience in Medical Device R&D – Proven track record in product development, engineering, and innovation within the medical device industry.
- Regulatory & Compliance Expertise – Strong understanding of FDA (510k, PMA), ISO 13485, CE Marking, and other global regulatory requirements.
- Strategic Leadership & Innovation – Ability to develop and execute R&D strategies, manage cross-functional teams, and drive product pipeline development.
- Strong Technical Knowledge – Expertise in materials science, mechanical and electrical engineering, and software integration for medical devices.
- Clinical & Preclinical Research Experience – Familiarity with clinical trials, validation testing, and real-world application of medical technologies.
- Intellectual Property & Patent Development – Experience in patent filings, competitive IP analysis, and technology licensing.
- Cross-Functional Collaboration – Ability to work closely with regulatory, quality, marketing, and manufacturing teams to ensure seamless product development.
- People Management & Leadership – Proven success in building, mentoring, and leading high-performing research and engineering teams.
If you have a passion for medical technology innovation and a strong background in leading R&D efforts, this role presents an exciting opportunity to shape the future of healthcare solutions.
Why This Opportunity Stands Out
The Director of R and D (Medical Device) in Boston, MA position is a high-impact leadership role in a company committed to developing cutting-edge medical technologies. This role offers:
- The Opportunity to Lead Groundbreaking Innovation – Play a key role in designing and developing next-generation medical devices that improve patient outcomes.
- A Strategic Position in a High-Growth Company – Join a rapidly expanding organization that is investing heavily in research, product development, and regulatory success.
- Executive-Level Impact – Work directly with senior leadership to define and execute the company’s R&D roadmap.
- Competitive Compensation & Benefits – Receive a strong salary package, performance-based incentives, and a comprehensive benefits package.
- Career Growth & Leadership Development – Opportunities to advance within the company as it expands its product portfolio and global reach.
- A Collaborative & Dynamic Team – Work alongside top-tier engineers, scientists, and regulatory professionals in a fast-paced, innovation-driven environment.
- The Chance to Make a Tangible Impact in Healthcare – Contribute directly to the development of medical devices that enhance surgical precision, patient care, and treatment efficacy.
FAQs About the Role
Q: What industries should I have experience in?
A: You should have a strong background in the medical device industry, specifically in research and development, product innovation, and regulatory compliance.
Q: Is relocation required for this position?
A: The role is based in Boston, MA. Candidates must be open to relocation or already reside in the area.
Q: What is the reporting structure for this role?
A: The Director of R and D (Medical Device) in Boston, MA will report directly to the Chief Technology Officer (CTO) and collaborate closely with regulatory, engineering, and commercial teams.
Q: What kind of leadership style is expected?
A: The company seeks a strategic, hands-on, and results-driven leader who can inspire teams, foster innovation, and drive R&D excellence.
Q: What is the expected travel requirement?
A: This role may require occasional travel for industry conferences, regulatory meetings, and strategic business engagements.
Q: What qualifications and skills are required?
A: Candidates should have a master’s or Ph.D. in biomedical engineering, mechanical engineering, or a related field, along with at least 10+ years of experience in medical device research and development. Strong leadership abilities, regulatory expertise, and technical innovation skills are essential.
Q: How does this role contribute to the company’s overall success?
A: The Director of R and D (Medical Device) in Boston, MA will be responsible for driving innovation, ensuring regulatory compliance, and overseeing product development to bring new medical devices to market successfully.
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. The onboarding process will include strategy meetings with leadership, technical deep dives, and alignment on R&D objectives.
What Remuneration Can You Expect from This Job?
As the Director of R and D (Medical Device) in Boston, MA, you can expect a highly competitive compensation package that reflects your leadership role in medical device innovation and research. The base salary typically ranges from $180,000 to $250,000 per year, depending on experience, expertise in R&D, and previous success in leading medical device development.
In addition to the base salary, this role offers performance-based incentives and bonuses tied to key milestones such as successful product launches, regulatory approvals, and revenue growth. Equity options or stock grants may also be available, allowing top candidates 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, paid time off, and professional development opportunities. Additional perks may include relocation assistance, executive-level travel allowances, and participation in industry conferences.
This position offers not only a lucrative financial package but also the opportunity to play a pivotal role in shaping the future of medical technology. If you are an experienced R&D leader passionate about innovation, this is a career-defining opportunity to make a lasting impact.
How to Apply for This Director of R and D (Medical Device) Position in Boston, MA
If you are a visionary leader with a proven track record in medical device research and development, we invite you to apply for the Director of R and D (Medical Device) in Boston, MA. This is a unique opportunity to drive innovation, lead high-impact projects, and contribute to groundbreaking advancements in healthcare technology.
To apply, please submit your resume and a cover letter detailing your experience in medical device development, regulatory compliance, and R&D leadership. Highlight your technical expertise, past achievements, and ability to lead cross-functional teams in bringing medical devices to market.
This role offers an exciting opportunity to shape the future of medical technology while working in a collaborative, innovation-driven environment. Apply today to take the next step in your career as a Director of R and D (Medical Device) in Boston, MA!
For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.
Tags:
Director of R and D | Medical Device Research & Development | Boston Medical Device Jobs | Healthcare Innovation | Biomedical Engineering | R&D Leadership
