Project Manager

The Company

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.

Job Summary

We are seeking an experienced and detail-oriented Project Manager to oversee and coordinate multiple concurrent workstreams supporting the continued development and commercialization of our growing product portfolio. This role will be responsible for schedule development, resource planning, and cross-functional alignment between engineering, quality, regulatory, operations, and commercial teams. The ideal candidate will bring strong organizational and collaborative skills along with a strategic mindset for managing project risk, timelines, and resource allocations. This is a unique opportunity to make a high-impact contribution at a critical stage in our commercial scale-up. This is a full-time, on-site (non-remote) position at our facility in Bedford, Massachusetts.

Key Responsibilities

• Lead project planning and scheduling across multiple concurrent workstreams
• Develop and maintain integrated project timelines, including key milestones, dependencies, and risk retirement points
• Coordinate cross-functional teams to align development activities with commercial and operational timelines
• Facilitate resource planning to ensure adequate staffing across functional teams
• Identify resource gaps/overloads, critical-path tasks, and project risks
• Drive timely decision-making through clear communication and status reporting
• Collaborate closely with engineering, quality, regulatory, manufacturing, field service, and marketing stakeholders
• Support project phase-gate reviews and ensure deliverables meet quality and regulatory standards

Minimum Qualifications

• 5+ years of project management experience in medical devices, biotechnology, or a related regulated industry
• Demonstrated experience managing complex schedules and cross-functional teams
• Strong understanding of product development processes and life cycle management
• Excellent written and verbal communication skills
• Exceptional organizational, analytical, and problem-solving skills
• Proven ability to manage multiple priorities and deadlines in a fast-paced environment
• Proficiency with project management tools

Desired Qualifications

• PMP certification or formal training in project management methodologies
• Master's degree in Engineering, Business Administration, or related discipline
• Experience working in early-stage medical device startups
• Familiarity with medical device regulations, ISO 13485, and regulatory submission processes (e.g., 510(k))
• Prior experience aligning R&D and commercial teams through launch phases

Applying

Apply directly to this role through the LinkedIn application, or email a resume/CV and introductory note to:

Will Goth, Ph.D.

Manager, Systems Engineering

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