Job Summary:
Werfen North America is a leading company in specialized diagnostics founded in 1966. They are seeking a Senior Software Test Engineer to lead testing activities, develop test frameworks, and ensure compliance with medical device regulations, while collaborating closely with various engineering teams.
Responsibilities:
• Lead testing activities including Software Feature Testing, Integration & System Testing, Regression Testing—covering UI, API, Functional, and Non-Functional testing (Performance, Load, Stress, Security)
• Maintain a comprehensive traceability matrix to ensure full test coverage
• Develop and maintain test frameworks, automation scripts, tools, test environments, and infrastructure
• Conduct peer reviews of software requirements and design documentation
• Review test cases, automation scripts, and test code for quality and accuracy
• Assess existing test processes and recommend improvements to increase efficiency and effectiveness
• Estimate, plan, and coordinate test activities while supporting ongoing testing efforts
• Ensure compliance with internal design controls and applicable medical device regulations and standards (e.g., ISO 13485, IEC 62304, 21 CFR Part 820.30)
• Lead a small testing team, delivering on key program milestones with a focus on timeliness and quality
• Manage complex projects and multiple personnel simultaneously
• Coach and mentor team members, supporting development through performance evaluation and leadership
• Drive continuous improvement initiatives to enhance test processes, increase automation, and reduce cycle times
Qualifications:
Required:
• Bachelor's degree in Engineering, Science or a related field
• Ten years of product development or relevant experience
• Six to eight years of product development or relevant experience for advanced degrees
• In vitro medical device experience highly desired
• Proficiency in Python and scripting languages such as Bash
• Experience with test automation frameworks including PyTest and pytest-bdd
• Hands-on experience with embedded device test automation
• Familiarity with CI/CD tools: Jenkins, Docker, Git (Bitbucket/GitHub/GitLab)
• Knowledge of BDD-based test development
• Understanding of embedded software concepts: OS, APIs, gRPC, MQTT, etc.
• Working knowledge of C++ and Java
• Agile/Scrum experience
• Proficiency with tools like DOORS, Jama, Jira, or equivalents
• Quick learner with strong analytical and problem-solving abilities
• Excellent communication skills—verbal, written, and presentation
• Strong team player and collaborator
• Passionate about emerging and disruptive technologies
• Self-starter with a proactive mindset
• Values transparency, trust, and a collaborative culture
• Open-minded and eager to learn beyond current expertise
• Process-oriented with a continuous improvement mentality
• Proficiency in English language required
Company:
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. Founded in 1959, the company is headquartered in Bedford, USA, with a team of 1001-5000 employees. The company is currently Late Stage.