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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.
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
This is an exciting opportunity to join our engineering team during a pivotal stage of commercial scale-up of our novel, best-in-class intravascular imaging system. We are seeking a talented Senior Systems Engineer with a strong background in integrating, testing, and verifying electromechanical devices, ideally with experience in complex optical or imaging-based systems.This individual will report to the Systems Engineering Manager and collaborate across multi-disciplinary engineering teams. They will lead system integration planning, requirements & test development, verification/validation, and documentation within a regulated environment. The ideal candidate is a methodical problem solver who pairs deep technical proficiency with a broad perspective of the product development lifecycle. This is a full-time, on-site (non-remote) position at our facility in Bedford, Massachusetts.
Key Responsibilities
* Collaborate with the engineering design team to integrate and test complex electromechanical hardware
* Support troubleshooting of hardware/software systems through a structured process
* Lead planning and execution Verification & Validation activities at the system level
* Define and manage system and sub-system requirements with traceability to user needs, risks, and tests
* Contribute to regulatory submissions by preparing clear and accurate technical documentation
* Own and maintain the Design History File (DHF) for multiple overlapping medical device programs
* Present plans, test results, and technical risks clearly and effectively to stakeholders
Minimum Qualifications
•Bachelor’s degree in relevant engineering or scientific fields (Systems/Biomedical/Electrical/Mechanical Engineering, Applied Physics, etc…)
•A minimum of 5 years of relevant technical experience in the medical device field
•Strong hands-on experience with electromechanical prototyping, hardware test fixture development, and system troubleshooting
•Proficiency in developing and executing test protocols
•Familiarity with Requirements Management tools (e.g., JAMA preferred)
•Working knowledge of quality systems (QMS) and medical device regulatory expectations
•Ability to manage multiple workstreams in a fast-paced, collaborative environment
•Excellent written and verbal communication skills
Desired Qualifications
•Scientific programming and instrument control capability (Python preferred)
•Automated test script development and data analysis capabilities
•Experience with “System of Systems” approach to requirements management across multiple interrelated products
•End-to-end product development experience: from concept through V&V, design transfer, and post-market support
•A proactive and collaborative mindset with a willingness to grow beyond the core role
Applying
To apply to this role, please use the LinkedIn application module, or email a resume/CV and optional introductory note to:
Will Goth, Ph.D.
Manager, Systems Engineering
wgoth@spectrawave.com
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Information Technology
* Industries
Medical Equipment Manufacturing
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