Principal System Test Engineer; Hybrid Boston

Job Details

The Principal Systems Test Engineer, R&D, provides technical leadership and technical direction within the V&V organization to support the development of innovative medical technology products and services. This role leads system-level verification and validation efforts across design control, new product development, and product improvements; develops and reviews test strategies, procedures, and protocols; verifies designs against requirements; analyzes test data; and identifies improvements to test equipment, methods, and processes.

The engineer also serves as a technical authority, mentors technical contributors, and partners with engineering, quality, and product teams to deliver safe, effective, and high-quality Haemonetics products.

Key Responsibilities:

• Lead system-level V&V for complex medical device, hardware, software, interface, and integrated system products.
• Develop and approve V&V strategies, requirements, test plans, protocols, procedures, and reports.
• Define robust test methods using risk-based, statistical, and design-of-experiments approaches.
• Provide technical leadership for system integration, test automation, fixtures, tools, and test equipment.
• Review V&V evidence, resolve technical issues, and support design reviews and cross-functional decision-making.
• Improve requirements/test management practices to strengthen traceability, coverage, consistency, and evidence quality.
• Communicate technical risks, status, recommendations, and rationale clearly to stakeholders.
• Mentor technical contributors in systems engineering, V&V practices, and medical device development.
• Perform other duties as assigned.

Qualifications:

• Bachelor's degree in Engineering, Computer Science, or related technical field.
• Strong understanding of regulated product development, including FDA design controls, ISO quality systems, CE Marking, and V&V expectations.
• Deep experience with system-level V&V, requirements management, traceability, risk management, test coverage, and objective evidence.
• Hands-on experience with system integration, test method validation, automated testing, engineering tools, fixtures, and test equipment.
• Experience with statistical analysis, design of experiments, and relevant tools such as Minitab, JMP, or equivalent.
• Experience with scripting, automation, or analytical tools such as Python, MATLAB, R, LabVIEW, or similar platforms.
• Strong technical judgment, communication, collaboration, mentoring, and problem-solving skills.
• Familiarity with reliability engineering methods such as RGT, RBD, Weibull analysis, ALT, HALT, and HASS preferred.

Preferred:

• Experience in medical device, software, hardware, or complex electromechanical system development.
• Proficiency with requirements/test management tools such as DOORS, Polarion, Cognition Cockpit, or similar platforms.