Job Description

Are you ready to join Connecticut Innovation’s vibrant community of innovators? Connecticut Innovations (“CI”) is Connecticut’s strategic venture capital arm, and we are passionate about serving our portfolio of 220+ companies across various industries, with strengths in life sciences, technology, and climate tech.

Come join one of our quickly growing portfolio companies, Perosphere Technologies!

About Perosphere Technologies

Perosphere Technologies is changing the way decisions are made for patients at risk for bleeding. A private medical technologies company, Perosphere is focused on development and commercialization of the novel PoC (point-of-care) Coagulometer, which informs diagnosis, treatment, and prevention through precision data, made immediately accessible to all. It is the only point-of-care (POC) diagnostic tool that effectively and swiftly tests clotting times across drug classes, including Direct Oral Anticoagulants (DOACs). The fast diagnosis and related appropriate treatment decisions the PoC Coagulometer enables will help establish a new standard of care in hospital emergency departments for patients at risk for bleeding and has the potential to improve efficiency, provide significant cost savings, and better patient outcomes.

Perosphere Technologies is funded by Advantage Capital Partners, Ambit Health Ventures, Connecticut Innovations, Ogden, and others, and has been awarded multiple federal grants from the National Institutes of Health (NIH).

Why Work at Perosphere Technologies?

• 1 out of 3 DOAC Patient Admissions are incorrectly diagnosed and treated
• Perosphere’s Coagulometer (ClotChek) is the only PoC device that can test coagulation in patients on DOACs
• ~$1 billion market opportunity across Emergency Department, DOAC Outpatient, and Heparin Inpatient segments
• $1 billion in cost reduction to hospitals and payers in the US, with improved standard of care
• Coagulometer readers and cuvettes manufactured under cGMP, ready for commercial production with launch in Europe in 2024 and U.S. to follow
• Company has doubled its employees in the last 15 months, with more planned hiring in 2024 and 2025

About the Role - Quality Engineer

We are seeking a detail-oriented and compliance-focused Quality Engineer to support the development of our diagnostic medical device software and to support all other Quality Engineering functions. This role is integral to ensuring high-quality medical devices through robust documentation practices and well-defined development processes, all in compliance with regulatory standards for medical devices.

Key Responsibilities

• Support QMS and product development including software, mechanical and electrical programs.
• Partner with software and medical device development teams to ensure quality and regulatory requirements are built into every phase of the software development lifecycle (SDLC) and medical device development lifecycle.
• Define, implement, and maintain standard operating procedures (SOPs), work instructions, templates, and quality records related to medical device and software design, development, and testing.
• Facilitate thorough investigations, develop effective action plans, and lead closure of customer complaints, nonconformances (NCs) and CAPA (Corrective Action and Preventive Action).
• Own and manage documentation control processes to ensure accuracy, traceability, and regulatory compliance.
• Support the creation and maintenance of key deliverables such as:
• Software Requirements Specifications (SRS)
• Design History Files (DHF)
• Risk Management Files (per ISO 14971)
• Verification & Validation (V&V) protocol and report documentation
• Traceability matrices (requirements → testing)
• Ensure compliance with applicable regulatory standards, including IEC 62304, ISO 13485, ISO 14971, and FDA 21 CFR 820.
• Work closely with cross-functional teams (RA/QA, Operations, Engineering, Research and Development) to audit and improve medical device and software development processes.
• Support internal and external audits and drive remediation actions where needed.
• Contribute to continuous improvement initiatives by identifying process inefficiencies and implementing solutions.
• Serve as a quality advocate and provide guidance on documentation best practices to software, design, manufacturing and other functional teams.
• Will be expected to support all areas of Quality Engineering.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, , Life Sciences, or a related field.
• 3–5+ years of experience in Quality System related Engineering including experience with medical device software development, ideally within the diagnostics industry.
• In-depth knowledge of IEC 62304, ISO 13485, ISO 14971, and related regulatory frameworks.
• Strong experience with technical documentation, configuration management, change control, and risk management processes.
• Familiarity with software development practices (Agile/Scrum) and tools (e.g., Jira, Confluence, Git).
• Experience working with electronic quality management systems (eQMS) is a plus.
• Excellent written communication, organization, and collaboration skills.
• Ability to interpret and apply regulatory requirements in a practical development setting.

Preferred Qualifications

• Experience in supporting regulatory submissions (FDA, CE marking).
• Certifications in Quality or Regulatory (e.g., ASQ CQE, RAPS, etc.) are a plus.
• Familiarity with cybersecurity standards (e.g., FDA premarket guidance) is beneficial.

Perosphere Technologies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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