Position Overview
SpectraWave is a commercial-stage company developing an intravascular, AI, imaging platform for percutaneous coronary interventions. Backed by marquee investors in MedTech such as Deerfield Management, Johnson & Johnson, SV Health, and Heartwork Capital (Owned by former CEO of Abiomed that led a $17B exit to J&J), SpectraWave has raised $50M to scale commercial efforts, which necessitates augmented manufacturing capabilities. We are hiring our Head of R&D & Systems Engineering.
We have partnered with Eman Namati, CEO, and Vivek Walimbe, COO, to hire our Head of R&D & Systems Engineering. This position will drive growth strategies, implement best processes across R&D, and manage multiple product lifecycles and timelines. Our Head of R&D will oversee Systems, Software, and Harware development for our disposables and capital equipment while managing cross-functional teams.
This position is based on site at SpectraWave’s headquarters in Bedford, MA. (relocation assistance available for the right candidate)
Position Details
Responsibilities
Leadership & Strategy:
• Define and execute the product development strategy, ensuring alignment with the company’s overall vision and regulatory requirements.
• Lead and mentor a cross-functional team, including engineering, R&D, and project management, to deliver innovative products on time and within scope.
• Collaborate with the COO and cross-functional peer leaders to align product development with operational capacities and market demands.
• Ensure that product development efforts stay compliant with evolving medical device regulations and industry standards.
Product Development & Execution:
• Lead the design, development, and commercialization of medical imaging systems, integrating complex electromechanical components, sterile disposables, and AI-based data science applications.
• Ensure full compliance with FDA regulations (510(k), PMA, etc.), ISO standards (e.g., ISO 13485), and other relevant global medical device standards throughout the product lifecycle.
• Oversee the creation of technical documentation, risk assessments, and design controls necessary for regulatory submissions.
• Work closely with the regulatory team to manage successful product submissions and ensure all regulatory requirements are met for market approval.
Cross-Functional Collaboration:
• Partner with the peer cross-functional leaders to ensure product development timelines align with manufacturing and supply chain capabilities.
• Collaborate with clinical, regulatory, marketing, and commercial teams to ensure that product development meets customer needs and market demand.
• Establish strong relationships with external regulatory bodies, key opinion leaders, and suppliers to ensure the smooth progression of development projects.
Innovation & Continuous Improvement:
• Promote a culture of continuous improvement, driving product innovation while maintaining strict adherence to quality and regulatory standards.
• Identify emerging technologies, materials, and processes that can be leveraged to enhance product performance and maintain regulatory compliance.
• Integrate AI and data science applications within the product portfolio, ensuring compliance with regulatory guidelines for software as a medical device (SaMD).
Risk Management & Problem-Solving:
• Proactively manage risks related to product development, including technical, regulatory, and clinical challenges.
• Lead the resolution of any issues that may arise during development to ensure regulatory compliance and maintain project timelines.
• Ensure that all quality assurance processes, including CAPA and non-conformance management, are adhered to throughout development.
Education & Training
• Bachelor’s degree in Engineering, Biomedical Engineering, or a related field. A Master’s degree, PhD, or MBA is highly desirable.
Skills & Experience
• 12+ years of experience in medical device product development, with extensive experience in medical imaging technologies, complex electromechanical systems, and sterile disposable components.
• In-depth knowledge of FDA regulations (510(k), PMA), ISO 13485, IEC 60601, MDR (Medical Device Regulation), and other global medical device regulatory frameworks.
• Proven track record of successfully leading products through the regulatory submission process and into commercialization.
• Experience with AI-based data science applications in healthcare or medical imaging is a strong advantage.
• Strong leadership experience, managing cross-functional teams in a fast-paced, high-growth environment.
• Expertise in medical device regulations and standards, including risk management, design controls, and quality management systems.
• Exceptional leadership and team-building skills with the ability to inspire and manage high-performing teams.
• Strong project management abilities, particularly in overseeing complex projects that involve multiple stakeholders and regulatory requirements.
• Excellent communication skills, capable of conveying technical and regulatory information to cross-functional teams, executive leadership, and external stakeholders.
• Ability to manage and mitigate risks while ensuring high-quality and regulatory-compliant products are delivered on time.
Other Requirements
Ability and willingness to commute or relocate to Bedford, MA
SpectraWAVE is a dynamic, venture-backed medical device startup on a mission to revolutionize the treatment of coronary artery disease (CAD)—the leading cause of mortality worldwide. Our flagship product, the HyperVue™ Imaging System, is FDA-cleared and represents a next-generation approach to intravascular imaging. By combining advanced DeepOCT™ technology, near-infrared spectroscopy (NIRS), and cutting-edge machine learning algorithms, HyperVue™ optimizes coronary stenting procedures, empowering interventionalists with precise, real-time insights in the catheterization lab.
Recently, SpectraWAVE secured a $50M Series B funding round led by Johnson & Johnson Innovation - JJDC, Inc., alongside other prominent MedTech investors. This capital infusion is accelerating our commercial expansion and driving product enhancements that will set new standards in cardiovascular care.
As we expand our presence in the U.S. market, we're seeking passionate, driven professionals to join our small, innovative team. At SpectraWAVE, we strive to make a direct impact on patients' lives by advancing technology that improves outcomes. If you're excited to be part of a collaborative and fast-paced environment where your work can truly make a difference, we want to hear from you.
Visit website
Download PDF
CEO
COO
