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Added 19 mins ago
VI
System Test Lead
Viasat, Inc.
Carlsbad, CA · Reston, VA · Germantown, MD
- $190,500 to $285,500 USD / year
We have an exciting new opportunity for a System Test Engineer to join our Government team! You will work with a cross functional team in the development of our latest generation government…
Added 19 mins ago
PN
Senior Software Engineer III
Pacific Northwest National Laboratory
Richland, WA · Seattle, WA
- $133,100 USD / year
An accomplished engineer with strong foundations in scalable system design, SI/ML development, and production software. You're ready to lead complex system components, mentor junior…
Added 19 mins ago
PN
Lead Software Engineer IV
Pacific Northwest National Laboratory
Richland, WA · Seattle, WA
- $161,300 USD / year
We are seeking an exceptional Lead Software Engineer to architect and build next-generation SI systems at PNNL, spanning agentic SI platforms, petabyte-scale data orchestration, and…
Added 38 mins ago
Staff Software Engineer (AI Native Development)
Payroll Integrations Inc
NY · Carlsbad, CA · Marietta, GA
We are hiring a Staff Software Engineer to lead AI-native development at Payroll Integrations. This is a new role and the most senior individual contributor position in engineering. Working…
Added 43 mins ago
Field Coordinator
Entergy
Clinton, MS
Responsible for the identification of safety hazards, the elimination/mitigation of hazards on projects, assist with development of project scopes, supports development of project…
Added 55 mins ago
Sr Principal Engineer - 2292
Kioxia
Remote, United States
…technology, KIOXIA continues to pioneer innovative memory, SSD and software solutions that enrich people's lives and expand society's horizons. The company's innovative BiCS FLASH™ 3D flash…
Added 1 hour ago
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Patuxent River, MD
The Senior Engineer serves as a technical leader responsible for applying advanced engineering principles and systems engineering expertise to support the acquisition, development,…
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Lead Electrical Engineer
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Houston, TX
The Electrical Engineer is viewed as the subject matter expert for electrical circuitry products in Dresser’s New Product Development (NPI) Engineering group. They demonstrate…
Added 1 hour ago
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Senior Platform Software Engineer, AI
Oracle
Nashville, TN
- $92,500 to $209,500 USD / year
…generation of developer productivity platforms, intelligent development workflows, and AI-powered engineering tools and platforms that accelerate software delivery across the…
Added 1 hour ago
Senior Controls Integration Engineer, Worldwide Design and Engineering
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Nashville, TN
You are able to take the lead on the development, implementation, and delivery of complex system designs in ambiguous and complex problem spaces. You integrate systems for safety, security,…
Added 1 hour ago
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St. Jude Medical, Cardiology Division, I
CA
The position works closely with Development, Systems, DevOps, Product Management, Clinical Affairs, Cybersecurity, and Regulatory Affairs team to deliver secure, reliable, and compliant…
Added 1 hour ago
Build & Release Engineer
American Operations Corporation
Montgomery, AL
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Added 1 hour ago
Supervising Senior Automation Engineer I
Stellix
Foxborough, MA
We are currently looking for a Senior Process Automation Engineer who will develop high quality, well-tested and well-documented application software designs. You will lead DeltaV projects…
Added 2 hours ago
Sr IT Software Engineer
Palo Alto Networks, Inc.
CA
The Senior Software Engineer on the Data & Analytics team will design, build, and support full-stack applications; integrate AI technologies into existing and new applications to deliver…
Added 2 hours ago
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SDET Automation Engineer
Randstad USA
Washington, DC
- $50 to $58 USD / hour
Randstad is seeking a Senior SDET Automation Engineer to join a premier client in the Washington, DC area to lead the design, development, and scaling of enterprise-grade test automation…
Added 2 hours ago
Lead QA Engineer - Equity Only
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Remote, United States
We are seeking an experienced Lead QA Engineer to lead our quality assurance efforts. In this role, you will be responsible for ensuring the highest quality standards for our mobile…
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Lead Engineer
Medina Talent Group
Irvine, CA
- $135,000 to $150,000 USD / year
The Lead Engineer for Enterprise Applications is responsible for driving the design, development, modernization, and lifecycle management of enterprise application portfolios. This role…
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AI Full Stack Engineer (Volunteer)
Solution Community
Remote, United States
Volunteer AI Full Stack Engineer (AI-Native / Rapid Development)
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Senior Mechanical Engineer
Fabri
Billerica, MA
As Principal Systems Engineer, you will own the design, development, and deployment of Fabri’s core manufacturing equipment. You will operate bidirectionally with process engineering:…
Added 2 hours ago
Principal Systems Engineer
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Boston, MA
As Principal Systems Engineer, you will own the design, development, and deployment of Fabri’s core manufacturing equipment. You will operate bidirectionally with process engineering:…
Added 2 hours ago
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Remote, United States
We’re seeking a highly skilled and motivated Software Engineer to join our growing team. You will work as part of the engineering team to:
Added 2 hours ago
Billing Engineer
Tailscale
Remote, United States
We’re seeking a highly skilled and motivated Software Engineer to join our growing team. You will work as part of the engineering team to:
Added 2 hours ago
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Embedded Systems Engineer
Ulysses Inc.
San Francisco, CA
- $140,000 to $180,000 USD / year
We're looking for an Embedded Systems Engineer to own the firmware, electronics integration, and low-level hardware that make our underwater robotic systems work. You'll write the embedded…
Added 2 hours ago
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United States
…educational and/or professional experience/interest in the development of solutions to GPS Navigation Systems. The work is highly technical, and the individual will work collaboratively in…
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…businesses, world-class operations and investments in research and development, we offer capabilities and opportunity no one else can. Together, we push the boundaries of known science and…

Intuvie

Director, Systems Engineering

Natick, MA, United States

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Job details

Posting language: English
Posted: Nov 4, 2026

Original job description

Position Title: Director, System Engineering Department: Product Development

Reports To: VP, R&D FLSA: Exempt

GENERAL SUMMARY

The Director, System Engineering leads and personally contributes to the system-level development behind our infusion pump platforms, including new product development and on-market sustaining activities. The scope of the department responsibilities includes product requirements, risk analyses, human factors/usability engineering, system-level architecture and design documentation, V&V test planning and execution, root cause analysis, CAPA/NC ownership, on-market change control and QMS updates for related procedures and processes. This is a hands-on leadership role that brings a strong background in system engineering, medical device development and ability to mentor and lead a team of internal engineers and external contractors as needed. The position requires a solid understanding of system engineering principles while maintaining the flexibility to work within the existing process and toolsets without substantial reinvention. The role operates within our Quality Management System and partners closely with Software Engineering, Hardware Engineering, Project Management, Quality, and Regulatory to ensure system-level deliverables hold up our business, technical and regulatory requirements. We are a small, privately held medical device company. We move quickly, avoid internal politics, and our leaders strive to make sound technical and process decisions decisively with data rather than by committee. Our size and scale afford autonomy, a flat and low-drama culture, and flexible working arrangement in support of a healthy work-life balance.

ESSENTIAL JOB FUNCTIONS

Grow and manage a team of 5 or more junior to senior level engineers.
Work closely with the Chief System Architect and Chief Engineer to oversee and contribute to the architecture specification, implementation and the performance accountability of new products in development.
Facilitate and contribute to the resolution of technical issues and improvements of products in the field through NC and CAPA processes.
Lead technical teams in a collaborative environment, completing program deliverables per target timelines, scope, and budget.
Mentor younger engineers to develop the skills needed to resolve technical issues and interface with the broader cross-functional design team.
Establish and enforce good system engineering practices for deliverables including product requirements, architecture and design descriptions, and system-level test methods and protocols.
Serve as a primary technical interface with external product development contractors when required.
Interface with the hardware and software design leads to ensure system architecture is translated into system design.
Ensure system-level deliverables are consistent with our Quality Management System and support regulatory submissions.
Facilitate progress with the right mix of Agile methods and Waterfall deliverables, resulting in an efficient and fast pace of progress.
Work with Program Management to define and document program scope, constraints, and assumptions in detailed integrated program/project plans including schedule, resource needs, and budget.
Generate and communicate metrics of progress for the engineering programs and projects.
Establish and maintain a coherent perspective of program and technical risk and drive execution against risk mitigation plans as required to achieve program objectives and resolve technical issues.
Hold team members accountable for areas of responsibility to the program team and ensure support and focus on program objectives.
Contribute to technical summaries and resource estimates during RFP generation for new projects.
Maintain and project a positive attitude on the state of the union and the team’s progress.

OTHER DUTIES AND RESPONSIBILITIES

Additional responsibilities may or may not be assigned to the employee; role assignment will be reviewed on a case-by-case basis determinant upon individual strengths, experience, knowledge, and expertise.

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES

10+ years of experience with a bachelor’s degree, 8+ years of experience with a master’s degree, or 6+ years of experience with a PhD degree in Biomedical, System, Mechanical, Electrical Engineering or a related field.
Minimum of 8 years’ experience with system-level product design.
Minimum of 8 years as a lead system engineer, system architect, or chief engineer on new product development.
Minimum of 5 years medical device development experience, including successful 510k submission, or higher.
Experience with systems involving electro-mechanical, software, user interface, and disposable designs.
Excellent working knowledge of medical device development processes and system engineering deliverables.
Innovative thinker who can make sound technological decisions while making necessary technological tradeoffs.
Experience with specifying and implementing patient safety systems that are compliant with applicable standards and regulations.
Mastery of relevant system engineering tools.
Extensive working knowledge and application of IEC 60601 and related standards along with ISO 14971 for risk management.
Demonstrated capability for managing multiple engineering programs with shared resources.
Action-oriented self-starter who can drive complex projects with minimal guidance/oversight.
Exceptional organization and communication skills.
Ability to function in a fast-paced, growth industry and work environment.
Experience with infusion pump development or other relevant fluidic systems preferred.

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Skills

Root cause analysis
Engineering principles
Manage a team
Product comprehension
Program management
Electrical engineering
Risk management
Communication skills

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