Senior Systems Engineer Job at Apex Systems (Acton, MA or San Diego, CA)

Senior Systems Engineer

Apex Systems

Location:
United States , Acton, MA or San Diego, CA

Category:
IT - Software Development

Contract Type:
Not provided

Salary:

70.00 - 87.00 USD / Hour

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Job Description:

The Senior Systems Engineer will be a technical lead in the design and development of our client's innovation pipeline of wearable medical devices, including cloud and data management systems. This position entails leading systems engineering activities within existing and new product development projects. Education and work experience should encompass a vast array of engineering disciplines to include software, electrical, mechanical, and materials.

Job Responsibility:

Serve as a key member of a cross-functional project team consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables
Lead system definition tasks such as generating user needs, product requirements, and use-case descriptions
Contribute to system development by defining system and subsystem architectures
Identify and document system hazards, failure modes, and risk mitigations
Work with the technical centers of excellence domain subject matter experts and suppliers in the assessment, selection, integration, and qualification of key components and subsystems
Serve as technical consultant for integration, subsystem and system verification activities creating plans, protocols and reports, as necessary
Create and maintain traceability among design input, design output, design verification and validation, and risk management artifacts to ensure completeness and fully traceable design history file
Support the preparation of proposals, project plans and estimates, and present information and status to leadership and other stakeholders
Serve as technical consultant for software development deliverables, such as design/architecture documents, requirements and failure mode analysis
Participate in Agile ceremonies, such as Program Increment (PI) Planning, Retrospectives, Inspect and Adapt
Provide guidance and support to junior engineers, promoting knowledge sharing and professional development

Requirements:

Bachelor of Science in an Engineering (Systems, Biomedical, Electrical, Computer Science, Mechanical) discipline
A minimum of 3 to 7+ years of experience working as a Systems Engineer or with systems engineering responsibilities in a multidisciplinary project team environment
2+ years of experience in leading a cross-functional development team
Demonstrated expertise in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, hazards and risk assessments
Experience with long term R&D development programs (concept/feasibility, development, commercialization)
Experience in application lifecycle management tools (i.e. Polarion ALM, Helix ALM, Doors)
Experience with root cause analysis and troubleshooting
Experience writing verification plans, protocols and reports in a regulated industry
Experience with data analysis (Minitab, JMP, or MatLAB)
Proficient with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls)
Excellent project team skills
experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team, such as development, verification/validation, manufacturing, marketing, clinical, regulatory and quality experts
Ability to communicate at multiple levels of an organization
Ability to organize and judge priorities in a dynamic environment

Nice to have:

Master of Science degree is desired
System Engineering training and/or certification is a plus
Formal training in established Systems Engineering concepts
1-2 years of experience in Model-based Systems Engineering
1-2 years of experience working in Agile software development projects. Agile certification is a plus
Experience with change orders within a Product Lifecycle Management (PLM) tool (Arena PLM)
Demonstrated skills in developing and introducing innovative FDA regulated medical devices in the drug delivery market
Experience in reliability engineering practices such as reliability/data-based performance modeling, performance testing, prediction, HALT and HASS
1-2 years of experience working with 3rd party partners/vendors
Domain expertise in one or more of the following: security, cloud, communication (BLE, NFC), circuit design
Six sigma training / certification
2-3 years of experience in cloud technologies such as AWS and solid understanding of microservices, REST and HTTP
General understanding of communication, mobile technology, IoT (Internet of Things), GDPR
a strong plus
Experience with SolidWorks or Pro-Engineer
Experience with software tools and coding (C++, JAVA, Android UI)

What we offer:

medical, dental, vision, life, disability, and other insurance plans
ESPP (employee stock purchase program)
401K program with a company match after 12 months of tenure
HSA (Health Savings Account on the HDHP plan)
SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions
corporate discount savings program and other discounts
on-demand training program
access to certification prep and a library of technical and leadership courses/books/seminars after 6+ months of tenure
certification discounts and other perks to associations that include CompTIA and IIBA
dedicated customer service team
certified Career Coach

Additional Information:

Job Posted:
January 09, 2026

Employment Type:

Fulltime

Work Type:

On-site work

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