Lead Medical Device Systems Test Engineer

haemonetics; Boston (MA); On-site; USD 90,000 - 153,000; Full time

Job summary

Haemonetics in Boston is seeking a Principal Systems Test Engineer in R&D to provide technical leadership in V&V for medical device products. You will lead system-level verification and validation across design controls, new product development, and product improvements.

The role develops test strategies, reviews protocols, mentors engineers, and collaborates with engineering, quality, and product teams to deliver safe, effective Haemonetics products.

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.

Responsibilities

• Lead system-level V&V for complex medical device 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.

Skills

System-level V&V

Requirements management

Traceability

Risk management

Test coverage

Objective evidence

System integration

Test method validation

Automated testing

Scripting

Automation tools

Python

MATLAB

R

LabVIEW

Statistical analysis

Design of experiments

Minitab

JMP

Weibull analysis

ALT/HASS

Regulatory knowledge

Education

Bachelor's degree in Engineering, Computer Science, or related technical field

Tools

DOORS

Polarion

Cognition Cockpit

Job description

Haemonetics in Boston is seeking a Principal Systems Test Engineer in R&D to provide technical leadership in V&V for medical device products. You will lead system-level verification and validation across design controls, new product development, and product improvements.

The role develops test strategies, reviews protocols, mentors engineers, and collaborates with engineering, quality, and product teams to deliver safe, effective Haemonetics products.