> Markdown version of [/jobs/ext/172297-principal-software-quality-engineer-medical-device](https://www.wearedevelopers.com/jobs/ext/172297-principal-software-quality-engineer-medical-device). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Principal Software Quality Engineer - Medical Device - **Company:** Enhanced Compliance Inc. - **Location:** Marlborough, MA, United States - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Testing (Software), Software Bug Management, Cyber Security, Firmware, Failure Mode Effects Analysis, Issue Tracking Systems, Microsoft Office, Software Configuration Management, Software Engineering, Verification and Validation (Software), Software Version Control - **Published:** May 21, 2026 - **Apply:** https://business.massmedic.com/jobs/Details/principal-software-quality-engineer-medical-device-onsite-marlborough-ma-2949-330867 ## About the Role * Bachelor's degree in mechanical or biomedical engineering or related technical discipline. * Demonstrated experience working with implantable medical devices, including development, testing, validation, or product lifecycle support. * Demonstrated experience in firmware and software engineering. * Experience with software validation, including test planning, protocol execution, defect identification, documentation, and verification of system performance against requirements. * Experience with Issue Tracking Tools and requirements / test management tools. * Understanding of software configuration management (version control, Microsoft office tools) * Adaptable and effective collaborator in a team environment and in self-directed work * Strong communication skills (verbal & written) * Demonstrated use of Quality tools/methodologies * Strong knowledge of Quality System Regulation (QSR), Risk Management standards and software standards (IEC 60601) ## Description This is an exciting opportunity for a software focused Principal Software Quality Engineer supporting a cross-functional team on development and maintenance of Implantable and external devices and software. The role will apply the directives of design controls supporting the software development lifecycle (SDLC), software verification and validation (V&V), risk management, product development, run the business, and regulatory and standards compliance. This role is an onsite position in Marlborough, MA. What You'll Do * Participates in the implementation of new product software, including risk management (per ISO 14971), hazard analysis, software FMEAs, security risk analysis, software design V&V. * Applies software application development procedures and provides support to demonstrate compliance through technical documentation generation. * Participates in cross functional team meetings, software bug triage meetings to discuss, investigate and appropriately disposition internal software bugs and software field issues. * Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e. software bugs). * Works within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization. * Updates and maintains software risk management tools (i.e. Hazard Analysis, FMEAs). * Participates in Cybersecurity related discussions and assists supporting activities including Security Risk Analysis. * Leads and participates in software and electronic design reviews, design transfers, and in all aspects of the Design Control process for the PCI Guidance products. * Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices. * Assists in the design and development of software test cases and inspection procedures. * Supports regulatory submissions to notified bodies. * Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. ## Related Videos - [Playing Pong on a shoulder press machine](https://www.wearedevelopers.com/videos/100140-playing-pong-on-a-shoulder-press-machine) - [Thinking Differently - How to Make Money from Cyber Attacks & Cheats](https://www.wearedevelopers.com/videos/745-thinking-differently-how-to-make-money-from-cyber-attacks-cheats) - [Excellent Software Testing](https://www.wearedevelopers.com/videos/87-excellent-software-testing) - [Agent Smith Gets Hardware: Autonomous IoT Hacking From Debug Port to Cloud API](https://www.wearedevelopers.com/videos/100258-agent-smith-gets-hardware-autonomous-iot-hacking-from-debug-port-to-cloud-api) - [Quality Strategy with a side of Swiss Cheese](https://www.wearedevelopers.com/videos/467-quality-strategy-with-a-side-of-swiss-cheese) - [Cyber Security: Small, and Large!](https://www.wearedevelopers.com/videos/259-cyber-security-small-and-large) ## Related Articles - [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering) - [The 8 Best Code Testing Tools](https://www.wearedevelopers.com/magazine/402-the-8-best-code-testing-tools) - [Top Characteristics of a Software Engineer](https://www.wearedevelopers.com/magazine/166-top-characteristics-of-a-software-engineer) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [Software Engineer Career: Things You Should Know](https://www.wearedevelopers.com/magazine/143-software-engineer-career-things-you-should-know) - [Is Software Engineering Hard?](https://www.wearedevelopers.com/magazine/448-is-software-engineering-hard)