Principal System Test Engineer (Hybrid Boston)

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

Pay Transparency:

The pay range for this role is:

$90,100.00-$153,300.00/Annual

The base pay actually offered to the successful candidate will take into account, without limitation, the candidate’s location, education, job-knowledge, skills, and experience in prior relevant roles.

Incentives may also be provided as part of Haemonetics’ employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company’s long-term incentive plan, with eligibility and target amount dependent on the role.

In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, “flexible time off” for salaried employees and, for hourly employees, accrual of three to five weeks’ vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits.

If you believe you may be entitled to such information by law, you may contact 1-781-348-7777, Monday through Friday, 7:30 a.m. – 5 p.m. ET or email [e-mail].

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

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.

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