Job Summary: The Systems Engineer II supports the design, integration, verification, validation, and sustaining engineering of existing and new laboratory analyzers used in medical and pharmaceutical lab applications. Working under the general direction of Principal Engineers or an Engineering Manager or Director, this position collaborates with Mechanical, Electrical, Software, Chemistry, Quality, Manufacturing, Service, and other stakeholders to translate product and stakeholder needs into clear system requirements; define and evaluate subsystem interfaces; assess analyzer performance and design tradeoffs; investigate system-level issues; and develop objective evidence that designs meet approved requirements and intended-use expectations. The role performs engineering work within applicable product-development procedures, design controls, quality-system requirements, and document-control practices.
Responsibilities: - Translate stakeholder, user, product, and regulatory needs into clear, measurable, and verifiable system and subsystem requirements.
- Maintain traceability among product needs, system requirements, subsystem requirements, identified risks, and verification evidence.
- Maintain traceability among product needs, system requirements, subsystem requirements, identified risks, and verification evidence.
- Define, document, and evaluate interfaces among analyzer subsystems, including mechanical, electrical, software, optical, fluidic, and assay-related functions.
- Support system architecture and integration activities by identifying interface risks, evaluating design tradeoffs, and resolving cross-functional technical issues.
- Assess the impact of proposed design changes on system performance, requirements, risks, test coverage, manufacturing, service, and other downstream functions.
- Assess the impact of proposed design changes on system performance, requirements, risks, test coverage, manufacturing, service, and other downstream functions.
- Apply appropriate engineering and statistical analysis methods to evaluate system performance, design margins, variability, and test results using tools such as Minitab, MATLAB, Python, finite element analysis software, or equivalent applications, as applicable to the assignment.
- Develop system verification strategies, test methods, protocols, acceptance criteria, and reports demonstrating that design outputs meet approved requirements.
- Execute or coordinate engineering and software-related testing using company analyzers and laboratory test equipment; analyze results using appropriate statistical methods; document deviations; and communicate conclusions and residual technical risks.
- Execute or coordinate engineering and software-related testing using company analyzers and laboratory test equipment; analyze results using appropriate statistical methods; document deviations; and communicate conclusions and residual technical risks.
- Support risk-management activities by identifying system hazards, contributing to risk analyses, and verifying implementation and effectiveness of risk-control measures.
- Prepare for and participate in design reviews by presenting requirements, system analyses, test results, unresolved issues, design tradeoffs, and recommendations.
- Produce clear, technically accurate requirements, protocols, engineering reports, investigations, and design-review materials in accordance with applicable quality-system and document-control practices.
Experience Requirements: - Bachelor's degree in systems, mechanical, electrical, biomedical, or a related engineering discipline.
- 3-5+ years of engineering experience supporting the development, integration, testing, or sustaining engineering of multidisciplinary products; equivalent demonstrated capability may be considered.
- Demonstrated ability to troubleshoot multidisciplinary electromechanical systems using structured problem-solving and root-cause investigation methods.
- Ability to develop clear, measurable engineering requirements, test methods, acceptance criteria, and technical conclusions.
- Experience planning, executing, or supporting engineering verification testing and analyzing test results.
- Strong analytical and critical-thinking skills, including the ability to evaluate system interactions, design tradeoffs, variability, and technical risk.
- Ability to manage multiple priorities in a fast-paced, dynamic product-development environment.
- Ability to manage multiple priorities in a fast-paced, dynamic product-development environment.
- Strong written and verbal communication skills, including the ability to prepare technically accurate requirements, test protocols, engineering reports, investigations, and design-review materials for cross-functional audiences.
- Experience with automated medical, diagnostic, or laboratory instrumentation preferred.
- Working knowledge of optical, fluidic, thermal, motion-control, sensor-based, or other multidisciplinary analyzer subsystems preferred.
- Experience with statistical and engineering analysis tools such as Minitab, MATLAB, Python, finite element analysis software, or equivalent applications preferred.
- Experience with CAD tools such as SolidWorks preferred.
- Familiarity with requirements management, design controls, risk management, verification traceability, and controlled technical documentation preferred.
- Ability to interpret software logic, analyzer workflows, logs, or source-level behavior to understand system function and support troubleshooting preferred.
Physical Requirements and Working Conditions: - Frequently operates computers, laboratory instruments, hand tools, and test equipment.
- Alternates between sitting and standing and may remain in either position for extended periods.
- Moves within laboratory, engineering, and manufacturing work areas.
- Performs fine-motor tasks involved in instrument assembly, adjustment, operation, and testing.
- Occasionally lifts, carries, or moves equipment or components weighing up to 20 pounds.
- Requires visual acuity sufficient to inspect components, operate instruments, and review computer-displayed data.
- Communicates and exchanges information in laboratory, engineering, and meeting environments.
- Uses required personal protective equipment in designated laboratory or manufacturing areas.
Why Work for Nova Biomedical - Flexible Medical, Dental, & Vision Coverage
- Competitive 401k company match
- Bonus Program, Generous PTO and paid holidays
- Generous Tuition reimbursement
- Hybrid and flexible work arrangements
- Professional development, engagement and events
- Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices
- Company subsidized cafeteria in our Waltham, MA office
Work Location: Onsite in Waltham, MA
Targeted Salary Range: $90,000 to $115,000 annually
Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate's experience and may vary based on individual factors such as location, skills, and education.
