Principal System Test Engineer (Hybrid Boston)
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Role details
Tech stack
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Job description
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., * 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.
Requirements
- Bachelorās 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.
Benefits & conditions
Incentives may also be provided as part of Haemoneticsā 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 Companyās 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, āflexible time offā for salaried employees and, for hourly employees, accrual of three to five weeksā 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.
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