Talent.com
Senior Quality Engineer - Software and Medical Devices

Senior Quality Engineer - Software and Medical Devices

Connecticut InnovationsDanbury, CT, United States
3 days ago
Job type
  • Full-time
Job description

Quality Engineer - Software and Medical Devices

Direct message the job poster from Connecticut Innovations

Talent Acquisition Partner at Connecticut Innovations | VC | TA & People Consulting for Startups

Are you ready to join Connecticut Innovations vibrant community of innovators? Connecticut Innovations (CI) is Connecticuts 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
  • Perospheres 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)
  • 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

  • Bachelors degree in Engineering, Computer Science, Life Sciences, or a related field.
  • 35+ 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.

    #J-18808-Ljbffr

    Create a job alert for this search

    Software Quality Engineer • Danbury, CT, United States

    Related jobs
    • Promoted
    Radiologic Technologist - General Radiology

    Radiologic Technologist - General Radiology

    Charlotte Hungerford HospitalCornwall Bridge, CT, US
    Full-time
    Charlotte Hungerford Hospital (10115).New Hires Eligible For Sign-On Bonus of $5,000! •.Every day, over 30,000 Hartford HealthCare colleagues come to work with one thing in common : Pride in what we ...Show moreLast updated: 2 days ago
    • Promoted
    Earn $150 Testing Future Tech Products!!!

    Earn $150 Testing Future Tech Products!!!

    uTest by ApplauseBedford, NY, US
    Full-time +1
    We are a company that helps businesses test the accuracy and usability of their websites, applications, and hardware through freelance software testing and feedback. You can get paid to help us shap...Show moreLast updated: 3 days ago
    • Promoted
    QUALITY ENGINEER

    QUALITY ENGINEER

    O2 Concepts, LLCMiddlebury, CT, US
    Full-time
    Responsible for sustaining and improving the processes required to manufacture a medical device under the guidance of an ISO 13485 Quality Management System, FDA requirements, and other internation...Show moreLast updated: 30+ days ago
    • Promoted
    Radiologic Technologist - Radiology

    Radiologic Technologist - Radiology

    Charlotte Hungerford HospitalLakeside, CT, US
    Full-time
    Charlotte Hungerford Hospital (10115).New Hires Eligible For Sign-On Bonus of $5,000! •.Every day, more than 40,000 Hartford HealthCare colleagues come to work with one thing in common : Pride in wha...Show moreLast updated: 2 days ago
    • Promoted
    Endocrinologist- Optum NY- Multiple Locations

    Endocrinologist- Optum NY- Multiple Locations

    OptumPort Jefferson, NY, US
    Full-time
    Optum NY, (formerly Optum Tri-State NY) is seeking a.Optum is a clinician-led care organization that is changing the way clinicians work and live. As a member of the Optum Care Delivery team, you...Show moreLast updated: 30+ days ago
    • Promoted
    Ultrasound Technologist - Radiology

    Ultrasound Technologist - Radiology

    The Hospital of Central ConnecticutMorris, CT, US
    Full-time
    Grand Street New Britain (10126).Work where every moment matters.Every day, more than 40,000 Hartford HealthCare colleagues come to work with one thing in common : Pride in what we do, knowing ever...Show moreLast updated: 2 days ago
    • Promoted
    Senior Software Engineer

    Senior Software Engineer

    RelativityBridgeport, CT, United States
    Full-time
    Join our team as we reimagine and modernize the core of Relativity's data architecture.You'll play a pivotal role in transforming the Document Data Model (DDM)-a foundational component of our platf...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Engineer

    Quality Engineer

    AdeccoWaterbury, CT, US
    Permanent
    We are seeking a hands-on Quality Engineer to join our manufacturing client located in Watertown, CT.This role supports quality activities across multiple projects, focusing on regulatory complianc...Show moreLast updated: 19 days ago
    • Promoted
    Sr. Quality Engineer

    Sr. Quality Engineer

    Cooper CompaniesTrumbull, CT, United States
    Full-time
    CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life.CooperSu...Show moreLast updated: 4 days ago
    • Promoted
    Senior Engineer, Process Engineering

    Senior Engineer, Process Engineering

    EntegrisDanbury, CT, United States
    Full-time
    Senior Engineer, Process Engineering.Here at Entegris, we use advanced science to enable technologies that transform the world, and we are seeking employees who have the drive to continue that miss...Show moreLast updated: 23 days ago
    • Promoted
    Quality Engineer

    Quality Engineer

    AMETEKBridgeport, CT, United States
    Full-time
    Responsible for meeting customer requirements for the manufacturing of surgical instruments and implants or instrument delivery systems from receiving raw material to the shipping of finished goods...Show moreLast updated: 4 days ago
    • Promoted
    Quality Engineer- Manufacturing- Sherman, CT

    Quality Engineer- Manufacturing- Sherman, CT

    Michael PageSherman, CT, United States
    Full-time
    Quality Engineer- Manufacturing- Sherman, CT.Quality Engineer- Manufacturing- Sherman, CT.Quality Engineer- Manufacturing- Sherman, CT. Be among the first 25 applicants.Quality Engineer- Manufacturi...Show moreLast updated: 4 days ago
    • Promoted
    Physician (MD / DO) - Hematology and Oncology - $425,000 to $525,000 per year in New Milford, CT

    Physician (MD / DO) - Hematology and Oncology - $425,000 to $525,000 per year in New Milford, CT

    LocumJobsOnlineNew Milford, CT, US
    Full-time
    LocumJobsOnline is working with CompHealth to find a qualified Hematology and Oncology MD in New Milford, Connecticut, 06776!. Come practice in New Milford, located in picturesque Litchfield County,...Show moreLast updated: 30+ days ago
    • Promoted
    Get Paid $$ to Test the Next Generation of Wearable Technology!!

    Get Paid $$ to Test the Next Generation of Wearable Technology!!

    uTest by ApplauseBedford, NY, US
    Full-time +1
    We are a company that helps businesses test the accuracy and usability of their websites, applications, and hardware through freelance software testing and feedback. You can get paid to help us shap...Show moreLast updated: 3 days ago
    • Promoted
    Med Device Quality Engineer

    Med Device Quality Engineer

    AptyxWest Torrington, CT, US
    Full-time
    The Quality Engineer in Medical Plastic Injection Molding is responsible for overseeing and ensuring the quality of existing and new products and processes within the medical device manufacturing e...Show moreLast updated: 12 days ago
    • Promoted
    Electronics Engineer

    Electronics Engineer

    U.S. NavyUpton, NY, US
    Full-time +1
    To be eligible to enlist in the U.Navy, candidates must be between the ages of 18-34.Every successful engineering career needs a solid foundation, and thats exactly what youll get.Do your job right...Show moreLast updated: 3 days ago
    • Promoted
    Director of Biostatistics for Cancer Center Shared

    Director of Biostatistics for Cancer Center Shared

    InsideHigherEdStony Brook, New York, United States
    Full-time
    Director of Biostatistics for Cancer Center Shared Resource, Associate / Full Professor, Cancer Center & Family Population & Preventive Medicine, Biostatistics. Oct 30, 2025 at 11 : 59 PM Eastern Time ....Show moreLast updated: 28 days ago
    • Promoted
    Senior Quality Engineer

    Senior Quality Engineer

    HANWHA AEROSPACE USA LLCCheshire, CT, US
    Full-time
    Job Title : Senior Quality Engineer.Hanwha Aerospace USA has long been recognized as a leader in the development and supply of flight critical Aerospace / Defense components and assemblies.Operating o...Show moreLast updated: 16 days ago