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Staff Software Engineer, Cortex AI Functions
Snowflake
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…filtering, joins, summarization, and aggregation - so customers can process and analyze structured and unstructured data together in a single hybrid query or pipeline through Snowflake’s…
Added 1 min ago
Subject Matter Expert (Manufacturing Engineer) - Optics Polishing
Coherent Corp. US
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Establish and optimize process parameters for dimensional, surface, and optical quality requirements.
Added 1 min ago
Gas Engineer II Control Systems and SCADA
CenterPoint Energy
Houston, TX
The Gas Engineer II Control Systems and Scada will support the Company’s Gas Control and SCADA process control systems. Provide engineering design and recommendations for Gas Control…
Added 1 min ago
BIM Coordinator
Tetra Tech, Inc
Portland, OR
Communicate and collaborate with clients, consultants, and other external stakeholders under the direction of the Project Engineer or Project Manager to address BIM coordination…
Added 1 min ago
Senior SailPoint Administrator
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Eagan, MN
Participates in the RFP process to evaluate and select vendor solutions.
Added 3 mins ago
CA Building Group Field Engineer I
Sundt
Sacramento, CA
Assists the Project Engineer with being the technical source of information for the project. Responds to questions about drawings, specifications, shop drawings, and change orders and have…
Added 3 mins ago
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Senior Instrumentation & Controls Engineer
AECOM
Remote, United States
- $125,000 to $170,500 USD / year
AECOM is seeking a highly motivated Senior Instrumentation and Controls (I&C) Engineer to join our Mining Project Delivery team in support of mining projects.
Added 3 mins ago
Senior Missile Defense System Architecture Engineer
Parsons Government Services Inc.
VA
Parsons is looking for an amazingly talented Senior Systems Engineer to join our team! In this role you will get to lead or participate in analysis of future Missile Defense System (MDS)…
Added 4 mins ago
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Staff Electrical Engineer
Insight Global
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- $114,000 to $150,000 USD / year
Insight Global is seeking a Staff Electrical Engineer - Wireless/RF/EMC, who is a project-level technical leader responsible for the electrical and wireless technical outcomes of new…
Added 4 mins ago
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Distribution Designer
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Rockville, MD
- From $28 USD / hour
…responsible for field surveying, field notes and sketches. Project types will include design of aerial and underground electric network distribution lines. Will work under the supervision…
Added 4 mins ago
Associate Mechanical Engineer
United Integrated Services (USA) Corp.
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Perform requirements classification of clients, communicating project requirements and design review with internal & external design team for Mechanical System, such as, process exhaust…
Added 4 mins ago
Estimator
Cementation USA
Sandy, UT
…and allocation of available resources to each phase of the project. Be able to prepare proposals for competitively bid and/or engineering studies at the scoping, pre-feasibility and…
Added 4 mins ago
Engineering Internship – Mechanical/Electrical/Civil/Struct/Mining
Cementation USA
Sandy, UT
Assists the associated engineering department or project site in general duties.
Added 4 mins ago
Project Engineer
Honeybee Robotics, LLC
Longmont, CO
…manage and coordinate engineering and technical aspects of a project, ensuring it meets deadlines, budgets, and quality standards. You will be the primary point-of-contact to our customers…
Added 4 mins ago
Tooling Design Engineer II
Blue Origin Personnel, LLC
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Set, implement, and maintain schedules and budgets to ensure project completion.
Added 6 mins ago
Mechanical Designer/Engineer
Mazzetti, INC.
United States
Mazzetti is seeking a Mechanical Designer/Engineer based in the greater St. Louis area to join our engineering practice and contribute fully to the analysis, design, and documentation of…
Added 7 mins ago
Senior Software Engineer
FanDuel
Jersey City, NJ
As a Senior Software Engineer within FanDuel’s Risk and Trading Technology team, you will be an essential part of a cross functional agile team that directly impacts our business. You will…
Added 7 mins ago
Quantitative Software Engineer
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As a Software Engineer within FanDuel’s Trading Solutions team, you will be an essential part of a cross functional agile team that directly impacts our business. You will work…
Added 8 mins ago
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Network Engineer II
Systems Engineering Inc
Portland, ME
- $85,000 to $110,000 USD / year
We are currently seeking a full-time Network Engineer II to join our team. This client-facing role is responsible for implementing, maintaining, and supporting networking, security, and…
Added 9 mins ago
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Construction Storm Water Coordinator
Department of Transportation
CA
- $11,437 to $14,315 USD / month
Under the general direction of the Office Chief, a Supervising Transportation Engineer, the position serves as the Construction Storm Water Coordinator in the Headquarters Division of…
Added 10 mins ago
Graduate Engineer, Electrical - Solar
Black & Veatch Family of Companies
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Job Title : Graduate Engineer, Electrical - Solar
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Graduate Engineer, Electrical - LNG
Black & Veatch Family of Companies
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Job Title : Graduate Engineer, Electrical - LNG
Added 12 mins ago
Engineer II-Absolute Aviation
HEICO
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Reverse engineer, troubleshoot, and lead the repair of complex aircraft components, both electrical and mechanical, using manual and automatic measuring equipment.
Added 13 mins ago
Sales Engineer
Downhole Chemical Solutions
Pleasanton, TX
We are seeking an experienced Sales Engineer to join our team in the San Antonio, TX area. This position serves as a critical liaison among operations, engineering, sales, and our clients,…
Added 13 mins ago
Sales Engineer - Houston
Downhole Chemical Solutions
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We are seeking an experienced Sales Engineer to join our team in the Houston, TX area. This position serves as a critical liaison among operations, engineering, sales, and our clients,…

Intuvie

Director, Systems Engineering

Natick, MA, United States

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Job details

Posting language: English

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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