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 Manufacturing to enable us to meet 100,000 units per year.
• Media: Eman Namati, SpectraWAVE – AI-enabled Intravascular Imaging
• Press: SpectraWAVE secures 510(k) clearance
We have partnered with Eman Namati, CEO, and Vivek Walimbe, COO, to hire our Head of Manufacturing. This position will own the scaling of on-site manufacturing for electromechanical disposables from 5,000 to 100,000 per year and capital equipment from 20 to 400 per year. Our Head of Manufacturing will interface with various global suppliers while leading final assembly in a hands-on manner while leading a team of 10 direct reports. This position is based onsite at SpectraWave’s headquarters in Bedford, MA.
Position Details
Responsibilities
Operational Leadership:
• Develop and execute the operational strategy to support the company’s growth, ensuring that production operations meet the evolving needs of the business.
• Collaborate with QA to ensure all products meet the stringent quality and regulatory standards required for medical devices, including compliance with FDA, ISO 13485, and other global regulations.
• Lead and manage production, ensuring the efficient scaling of manufacturing processes to meet product demand and commercialization timelines.
Production & Manufacturing:
• Oversee the company’s production operations, ensuring high-quality and cost-effective manufacturing processes.
• Lead efforts to scale manufacturing capabilities in response to increasing product demand while maintaining product quality and consistency.
• Implement Lean Manufacturing, Six Sigma, or other continuous improvement methodologies to increase efficiency and reduce waste in the production process.
Advanced Manufacturing Engineering:
• Build and lead Advanced Manufacturing Engineering capability to develop and implement innovative manufacturing processes, technologies, and automation solutions.
• Drive continuous improvement initiatives, including Lean Manufacturing, Six Sigma, and automation, to optimize production efficiency and minimize waste.
• Collaborate closely with R&D team to incorporate advanced manufacturing considerations early in the design phase to improve manufacturability and reduce time-to-market.
• Establish and maintain advanced manufacturing protocols and ensure alignment with regulatory and quality requirements.
Supply Chain Engagement:
• Develop strategies to ensure reliable, cost-effective sourcing of components, especially complex electromechanical and sterile disposable components.
• Collaborate with the R&D team to ensure alignment between supply chain and product development timelines, ensuring timely delivery of components and materials.
• Oversee product shipping and fulfillment processes, ensuring efficient and timely delivery of products to customers.
• Work closely with the sales team to align on fulfillment needs, optimize order processing, and ensure that customer expectations for delivery timelines and service are met.
• Develop and implement inventory management systems to minimize stockouts and delays, ensuring consistent product availability for customer orders.
Cross-Functional Collaboration:
• Partner closely with the R&D team to ensure smooth handoffs from product development to production and commercialization.
• Collaborate with the COO and other executive leadership to drive operational improvements and contribute to the overall business strategy.
• Build and maintain strong relationships with external stakeholders, including suppliers, regulatory bodies, and key partners.
Education & Training
• Bachelor’s degree in Engineering, Operations, Supply Chain Management, or a related field. A Master’s degree or MBA is highly preferred.
Skills & Experience
• 10+ years of experience in operations management, supply chain, and/or production, with at least 5 years in a leadership role in the medical device industry.
• Deep understanding of FDA regulations, ISO 13485, and other global medical device regulatory standards.
• Proven track record of successfully scaling manufacturing and operational processes in a fast-paced, high-growth environment.
• Experience with quality assurance in a regulated industry, with a focus on medical devices.
• Strong background in supply chain optimization, vendor management, and production oversight.
• Exceptional leadership and people management skills, with a proven ability to build and develop high-performing teams.
• Strong operational acumen with experience in Lean Manufacturing, Six Sigma, or other process improvement methodologies.
• Excellent project management skills, capable of managing complex projects across multiple functions and stakeholders.
• Strong problem-solving and decision-making skills, with the ability to troubleshoot operational challenges in real time.
• Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams and external partners.
Other Requirements
Ability and willingness to commute or relocate to Bedford, MA
Company Overview
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.
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