Welcome page Returning Candidate? Log back in! Senior Systems Engineer Job Locations US-MA-Bedford Job ID 2025-8254 Type Regular Full-Time Shift 1st Category R&D Overview

Position Summary:

 

Using Engineering procedures standard for research and development, carries out assignments associated with research, design, development, support or manufacturing of specific parts, processes, software or components of medical diagnostic systems.  Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.  Under the general direction of a functional manager, with moderate latitude for self-direction, operates in one or more areas of responsibility within a specific function.

Responsibilities

This role will be the lead Systems Engineer for new product development of a GEM Premier instrument, which is a whole blood diagnostic instrument for measuring pH, blood gases, electrolytes, metabolites, and more. The architecture of a GEM Premier instrument is being refreshed to address obsolescence and modernize the user experience. Systems Engineering is the functional group within R&D Hardware Engineering that is responsible for integrating hardware into full systems with software and firmware. Major areas of focus are unit integration, configuration management, requirements engineering, risk management, and verification.

 

Research, design, develop, and support manufacturing of specific parts, processes, software or components of medical diagnostic systems. Independently evaluate, select, and apply standard engineering techniques, procedures, and criteria, using judgment in making adaptations and modifications.

 

Key Accountabilities

Essential Functions:

Acts as a technical lead for a specific project.Accountable for the completion of assigned deliverables in accordance with approved schedules.Authors documentation and participates in activities in support of design controlIndependently plans, performs & prioritizes tasks that are moderately complex in nature, in alignment with corporate goals.Analyzes and interprets data, identifying trends and formulating the next steps, if required by the function.Integrates hardware with software/firmware componentsLeads development of product requirements and risks, including but not limited to:System and subsystem requirementsSubsystem specificationsDesign and User Failure Mode Effects & Critical Analysis (d/uFMECAs or d/uFMEAs)Traceability matricesDesign change risk assessmentsUser needs, human factors, usabilityLeads product verification through protocols/execution/reportsCharacterizes product reliability at both the system and subsystem levelsIdentifies product defects and recognizes outliers in results. Can explain and document product defects and their impact.Effectively communicates complex technical information to a cross-functional team in the form of documentation, presentations, and technical summaries.Technical expertise in complex electromechanical devicesProvides technical guidance to and/or supervision of other group members and cross-functional technical teams. Able to mentor others.Provides technical support for or leads investigations in support of development and/or on-market activities.Independently generates predictable schedules for activities related to assigned projects.Oversees hardware development performed by an external consultant

Secondary Functions:

May review and provide input to deliverables from other functions.Recommends and implements improvement initiatives to aid department practices.

Budget Managed: (if applicable)

N/A

Internal Networking/Key Relationships

To be determined based on department needs, to include interactions such as:

Will interface on a regular basis with groups across the organization as needed

Skills & Capabilities:

The ideal candidate for this position will exhibit the following skills and capabilities:

Statistical Analysis (if required by the function), Root Cause Analysis, Creative Problem Solving, Critical ThinkingTechnically adept and confidentLeadership: Accountability, Decision Making, Influence, CommunicationMentoringProduct development of complex electromechanical devices Qualifications

Minimum Knowledge & Experience Required for the Position:

 

Education:

Bachelor's degree in Engineering, Science or a related field

Experience:

Eight years of product development or relevant experienceFour to six years of product development or relevant experience for advanced degreesFor internal candidate promotion: Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experienceIn vitro medical device experience highly desired.

Additional Skills/Knowledge:

Language: Proficiency in English language required

International Mobility:

Required: No

Travel Requirements:

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