Medical Device Test Engineer Jobs in Boston, MA (NOW HIRING)

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.  We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Position Summary:

Using Engineering procedures standard for research and development, carries out assignments associated with research, design, development, support or manufacturing of specific parts, processes, software or components of medical diagnostic systems.  Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.  Under the general direction of a functional manager, with moderate latitude for self-direction, operates in one or more areas of responsibility within a specific function.

Essential Functions:

• 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

Collaborate closely with Software Developers, System Engineers, DevOps Engineers, and Scientists in an Agile/Scrum environment.

Technical Expertise:

• 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

Minimum Knowledge & Experience Required for the Position:

Education:

• Bachelor's degree in Engineering, Science or a related field

Experience:

• Ten years of product development or relevant experience
• Six to eight years of product development or relevant experience for advanced degrees
• For internal candidate promotion: Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experience
• In vitro medical device experience highly desired.

Additional Skills/Knowledge:

• Language: Proficiency in English language required

International Mobility:

• Required: No

Travel Requirements:

• Some domestic and international travel may be required.

The annual base salary range for this role is currently $160,000 range to $180,000 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. 

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com