Medical Engineering Consultants (MEC) ยท 3 weeks ago
Firmware Test Engineer
Marlborough, MA
Full-time
Onsite
Senior Level
5+ years expMedical Engineering Consultants (MEC) support medical device and pharmaceutical companies to enhance their efficiency and productivity. The Firmware Test Engineer will focus on the verification and validation of embedded firmware for Class III active implantable medical devices, ensuring compliance with regulatory standards.
ConsultingMedical DevicePharmaceuticalTraining
No H1B
Responsibilities
Develop and execute test plans protocols and reports for firmware verification and validation in compliance with IEC 62304 and FDA regulations
Design implement and maintain test automation frameworks and tools to support continuous integration and testing
Collaborate with software developers and system engineers to identify test requirements and ensure comprehensive coverage
Support test infrastructure development including hardware-in-the-loop setups and simulation environments
Prepare develop and execute risk-based product software testing Unit Integration Tests in compliance with IEC 62304 60601 and other applicable standards
Prepare high-quality test deliverables aligned with ISO 14971 for regulatory submissions
Support both product and manufacturing process software test method development verification and validation
Participate in design and code reviews and associated integration activities
Qualification
Required
Bachelors degree in computer science software engineering electrical engineering or related field
5 years of experience in software testing for regulated environments preferably medical devices
Practical and working knowledge of C# BSC TES framework IEC 62304 IEC 60601 and ISO 14971
Strong understanding of verification and validation processes for Class III medical devices
Experience with test automation scripting and CI/CD tools Jenkins Bitbucket JIRA
Demonstrated ability to generate compliant documentation for audits and regulatory submissions
Preferred
Experience with class III active implantable firmware verification
Familiarity with risk-based test approaches and traceability management tools Cognition Cockpit
Familiarity with product integration projects and global team collaboration is a plus
Company
Medical Engineering Consultants (MEC)
MEC is a comprehensive solution provider with a full suite of services from consulting and contracting to training and cost savings initiatives.
Founded in 2011Fort Lauderdale, Florida, USA
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Christopher Gustine
Managing Partner
David Campo
Managing Partner
Company data provided by crunchbase