Senior Systems Engineer

Werfen•Bedford, MA

18h•$110,000 - $140,000

About The Position

The Senior Systems Engineer supports system integration, verification, validation, defect analysis, and remediation activities throughout product development. This role is responsible for translating user needs and system requirements into system-level verification and validation test cases, executing and documenting testing activities, supporting product risk management, and ensuring compliance with applicable regulatory requirements and standards. The engineer collaborates with cross-functional teams to analyze test results, identify issues and risks, support issue resolution, and verify the implementation and effectiveness of risk controls. The annual base salary range for this role is currently $110,000 to $140,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave.

Requirements

Knowledge of medical device standards and regulations, including ISO 14971, IEC 62304, IEC 62366, and FDA GMP/QSR, and their impact on verification and validation activities.
Experience executing system-level or integration test activities for complex products.
Ability to analyze test results and identify issues and risks.
Ability to support risk management activities, including DFMEA and risk control verification.
Effective collaboration and communication skills within cross-functional teams.
Knowledge of system integration principles and system-level testing methodologies.
Understanding of embedded software design, implementation, integration, and test activities.
Ability to diagnose and troubleshoot system performance issues using equipment, schematics, and algorithm analysis.
Proficiency in English language required
Bachelor's degree in Engineering, Science or a related field
Eight years of product development or relevant experience
Four to six years of product development or relevant experience for advanced degrees

Nice To Haves

Experience with requirements management, digital traceability tools, and test automation preferred.
Experience working with electromechanical and/or mechatronic systems.
Experience with control systems; stepper motor control experience preferred.
Programming experience, preferably Python.
Experience using test and measurement equipment, including oscilloscopes, digital multimeters (DMMs), and logic analyzers.
In vitro medical device experience highly desired.

Responsibilities

Owns system-level defect analysis and remediation during System Integration, Verification, and Validation phases.
Supports Product Risk Management activities, regulatory and standards compliance, and country approval efforts.
Conducts risk analyses, including Design Failure Mode and Effects Analysis (DFMEA), and supports the development of risk control measures.
Translates user needs and system requirements into system-level verification and validation test cases with appropriate traceability.
Executes and documents system integration, verification, and validation testing involving hardware, software, subsystems, and external interfaces.
Analyzes test results, identifies issues and risks, and collaborates with cross-functional teams to support timely resolution.
Participates in system test, technical, and design reviews with a focus on verification coverage, defects, and readiness milestones.
Supports Product Safety Risk Management activities by verifying implementation and effectiveness of assigned risk controls in a regulation-compliant manner.
Applies standard test practices, tools, and templates and contributes to continuous improvement of system test processes.
Conducts cascade analysis and error budget allocation
Effectively communicates complex technical information to a cross-functional team in the form of documentation, presentations or technical summaries.
Independently generates predictable schedules for activities related to assigned projects.