Jobs in the United States

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Added 1 min ago
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Sales Enablement and Proposal Manager
RavenVolt
Remote, United States
- $95,000 to $125,000 USD / year
…salesperson as customer owner or require the employee to serve as an engineer, attorney, or formal sales-operations…
Added 1 min ago
Quality Associate III
Baxter Healthcare Corporation
Round Lake, IL
Mentor and coach investigators, contribute to calibration activities, and support the development of investigation capabilities across the organization.
Added 1 min ago
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Staff Software Engineer, Security Platform
Aalyria
Remote, United States
- $230,000 to $250,000 USD / year
As a Staff Software Engineer on the Security Platform team, you'll set the direction for how Aalyria secures Spacetime. The team owns security for Aalyria products, and we build each…
Added 1 min ago
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Software Engineer, Security Platform
Aalyria
Remote, United States
- $155,000 to $175,000 USD / year
As a Software Engineer on the Security Platform team, you'll build the identity, credentials, and audit capabilities that secure Spacetime. The team owns security for Aalyria products, and…
Added 2 mins ago
Sr. CyberArk Implementation Engineer or Architect
Capgemini
Atlanta, GA, GA
We are seeking an experienced Senior CyberArk PAM Implementation Engineer to assess, optimize, and enhance our existing CyberArk Privileged Access Management environment. The ideal…
Added 2 mins ago
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Mechanic Engineer Senior
Longmont United Hospital
Longmont, CO
- $30.24 to $49.9 USD / hour
…powerful connection of body, mind, and spirit in the healing process. Here, your time at work will be spent with a supportive team of employees and leaders that value self-care, flexibility…
Added 2 mins ago
Senior Manufacturing Engineer – CNC Programming & Machining
Confidential Recruiting Partners
Bolingbrook · Bolingbrook, IL
Our client is seeking a hands-on Senior Manufacturing Engineer with strong CNC programming and machining expertise to support production operations and continuous improvement initiatives.…
Added 3 mins ago
Senior Electrical Engineer - Substation (Kansas City)
Burns & McDonnell
Kansas City, MO
The Senior Substation Engineer will lead the preparation of design deliverables for new and modified high-voltage (13kV to 765kV) electrical power substation projects. The Senior Substation…
Added 4 mins ago
Commissioning Engineer - Buildings
Burns & McDonnell
Kansas City, MO
Description Burns & McDonnell has an exciting opportunity for a Staff Commissioning Engineer with a desire to achieve more in their professional career. At Burns & McDonnell we work on…
Added 4 mins ago
Assistant Pre-Construction Manager - Heavy Civil (Kansas City)
Burns & McDonnell
Kansas City, MO
…and subcontractors in the day-to-day management of proposal development and pre-construction activities for Design-Build (DB), Construction Management at Risk (CMAR), Engineer Procure…
Added 5 mins ago
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Senior Manager, FW Engineering - Global Converse
Converse Inc.
Boston, MA
- $139,700 to $294,100 USD / year
Partner with Development from early concept through commercialization to identify risks earlier and engineer effective solutions.
Added 5 mins ago
HVAC Controls Engineer
SpaceX
Hawthorne, CA
Participate in initial equipment conceptual development and carefully balance product specifications, process requirements, layout complexity, cost, and lead-time limits
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Hardware Platform Engineer - Data Center Systems & Rack Integration
Oracle
Jefferson City, MO
- $114,600 to $234,600 USD / year
Added 5 mins ago
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Transmission Planning Consultant - 1898 & Co. (Multiple Locations)
Burns & McDonnell
Kansas City, MO
- $110,000 to $400,000 USD / year
+ Support project managers with technical execution, client deliverables, and proposal development.
Added 5 mins ago
Staff Design Engineer, Stormwater
Contech Engineered Solutions LLC
Clackamas, OR
As a Stormwater Staff Engineer at Contech, you will play a key role in maintaining our civil engineering client relationships by assisting them with the design and implementation of…
Added 6 mins ago
Senior Underground Engineer (Kansas City)
Burns & McDonnell
Kansas City, MO
A Senior Cables Engineer will lead various phases of planning, proposal preparation, site evaluations, analytical designs, report preparation, specifications, and preparation of…
Added 6 mins ago
Senior Instrument & Controls Engineer - OnSite Energy & Power (Multiple Locations)
Burns & McDonnell
Kansas City, MO
Description The Senior Instrumentation & Controls (I&C) Engineer will support and lead the design and development of process/plant/building control systems for distributed generation and…
Added 7 mins ago
Mechanical Engineer - Industrial Water/Wastewater (Kansas City)
Burns & McDonnell
Kansas City, MO
The Mechanical Engineer will work on mechanical design project teams to create world class designs for new projects, alterations and redevelopments on a variety of projects including power,…
Added 7 mins ago
Director - Customer Response Engineering
Musarubra US, LLC
Remote, United States
Deep technical skill with an AI-first mindset. You can read a crash dump, a process trace, or a packet capture and argue root cause with senior engineers. Your first move on a hard problem…
Added 7 mins ago
Security Engineer
Cala Health
United States
We are seeking a hands-on Security Engineer embedded within our engineering organization. In this role, you will be the primary technical authority securing our AWS cloud architecture,…
Added 7 mins ago
Staff Kernel Optimzation Engineer
Cerebras Systems
Sunnyvale, CA
As a Kernel Engineer on our team, you will develop high-performance software solutions at the intersection of hardware and software, developing high-performance software for cutting-edge AI…
Added 7 mins ago
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Senior Mechanical Engineer - Consumer & Life Solutions (Multiple Locations)
Burns & McDonnell
Saint Louis, MO
- $135,000 to $210,000 USD / year
Description The Senior Mechanical Engineer will lead mechanical design projects and teams to create world-class designs for new projects, alterations and redevelopments within the Life…
Added 7 mins ago
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Senior Mechanical Engineer - Consumer & Life Solutions (Multiple Locations)
Burns & McDonnell
Kansas City, MO
- $135,000 to $210,000 USD / year
Description The Senior Mechanical Engineer will lead mechanical design projects and teams to create world-class designs for new projects, alterations and redevelopments within the Life…
Added 7 mins ago
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Project Manager - Water (Multiple Locations)
Burns & McDonnell
Saint Louis, MO
- $130,000 to $325,000 USD / year
+ Lead the Project Management team in administering request for proposal (RFP) package development, bid and selection process, and scope of work documents.
Added 8 mins ago
Operations Engineer, Mechatronics Technical Trainer, Material Handling Equipment Systems, OneMHS
Amazon.com Services LLC
Austin, TX · Nashville, TN · Bellevue, WA · Atlanta, GA · Springdale, OH
…Installation and Deployment team, and we need a versatile Operations Engineer to help shape it from the ground up. As the team scales to support a growing network of fulfillment facilities,…

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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