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Added 3 mins ago
Mission Operations Engineer (Entry-Level) - Millennium Space Systems
Millennium Space Systems
Chantilly, VA
This position’s internal job code is Systems Engineer. Our team is currently hiring for a Level 1-2.
Added 3 mins ago
MS
Part-Time Mission Analysis Engineer - Millennium Space Systems
Millennium Space Systems
El Segundo, CA
- $21.15 to $30.77 USD / hour
- Part-time
…and simulation of satellites, constellations, and system-of-systems; and (c) design and integration of mission data processing algorithms, such as EO/IR image processing or inertial…
Added 3 mins ago
Software Developer, Phantom Works (Experienced or Senior)
The Boeing Company
Saint Charles, MO · Saint Louis, MO
The Boeing Company is seeking a Software Developer / Engineer (Experienced or Senior) to join the Phantom Works Weapons team in St. Charles, MO (St. Louis Area). This team supports future…
Added 5 mins ago
Systems Engineer III
Qualis LLC
Colorado Springs, CO
Qualis LLc is seeking a Systems Engineer III to support a growing portfolio of software products that focus on missile defense, space, and intelligence and will support various modeling,…
Added 10 mins ago
Senior Commercialization Process Engineer
Natera
San Carlos, CA
Natera is seeking a Senior Commercialization Process Engineer to serve as the critical bridge between assay development and scalable lab production. This bench-level role is embedded early…
Added 11 mins ago
Manufacturing Electrical Engineer
SEDAA
Plano, TX
The Manufacturing Electrical Engineer II will support manufacturing operations through the development, maintenance, troubleshooting, and continuous improvement of electrical test systems,…
Added 11 mins ago
Senior Software Engineering
Pearson
Montpelier, VT
As an Senior Software Engineering, you will serve as a senior technical owner and hands-on engineer responsible for designing, building, operating, and evolving scalable software solutions…
Added 11 mins ago
Supply Chain Capacity Engineer
Meta
Montpelier, VT
Meta is seeking a Planning & Capacity Engineer to join the Infrastructure Supply Chain and Engineering (ISCE) Planning team to focus on planning optimization for all of Meta’s…
Added 13 mins ago
Software Engineer, Triage Services
Apple
Cupertino, CA
The System Triage Services team builds mission-critical applications that help detect, analyze, and classify low-level software crashes across all Apple platforms.
Added 18 mins ago
MP
Electrical Engineer II
MESA POWER SOLUTIONS LLC
Evansville, WY
- $96,000 to $106,000 USD / year
Operating independently of day-to-day Senior Engineering oversight, the Electrical Engineer II owns the design, integration, optimization, and documentation of advanced industrial power…
Added 20 mins ago
Hardware Systems Engineer, Hardware Tools / Firmware
Cloudflare
Austin, TX
Cloudflare’s Hardware Team is hiring a Systems Engineer, with a firmware focus, in the U.S. to help deliver the Hardware team’s security goals and projects in 2027 & beyond.
Added 20 mins ago
Hardware Systems Engineer - AI Hardware
Cloudflare
Austin, TX
…components, as well as PDUs and network hardware. As a Hardware Systems Engineer, you will work with colleagues on the Engineering teams, Product and Performance teams, and Hardware…
Added 21 mins ago
Systems Engineer II
RTX
United States
…environments? Raytheon is seeking a talented and motivated Systems Engineer II to join our team within the Systems Engineering and Test Capabilities (SETC) Discipline, supporting the LTAMDS…
Added 21 mins ago
Electrical Engineer 1 (Onsite)
RTX
United States
The Rockford, IL Power and Controls division is looking for an entry level Electrical Engineer 1. This role is onsite, in Rockford, IL. This role may be eligible for relocation.
Added 21 mins ago
Systems Requirements & Specification Engineer Onsite
RTX
United States
Raytheon’s Systems Engineering and Test Capabilities (SE&TC) Surface Radars & Sensors Center is seeking a Senior System Engineer interested in leading requirements and specification…
Added 21 mins ago
Scrum Master – Senior Software Engineer
RTX
United States
Are you interested in joining a dynamic, growing professional organization? The Missile Defense Sensors (MDS) software department within Raytheon is looking for a Software Scrum Master (SM)…
Added 21 mins ago
Scrum Master –Software Engineer II
RTX
United States
Are you interested in joining a dynamic, growing professional organization? The Missile Defense Sensors (MDS) software department within Raytheon is looking for a Software Scrum Master (SM)…
Added 21 mins ago
Sr Service Engineer, Avionics Service and Support (Onsite)
RTX
United States
Collins Aerospace seeks an experienced Senior Systems Engineer to join its service engineering and support team in Cedar Rapids, Iowa, with the ability to provide on-site support as needed…
Added 21 mins ago
Senior Software Engineer - Modeling (Onsite)
RTX
United States
U.S. citizenship only (dual citizenship not permitted) is required, as access to information under this program/contract is restricted to individuals with sole U.S. citizenship. Most…
Added 21 mins ago
Senior Software Engineer - AVI MIL FMS (Onsite)
RTX
United States
Collins Aerospace is currently seeking qualified candidates for Senior Software Engineer roles in our Military Avionics Flight Management department located in Cedar Rapids, Iowa. Teams are…
Added 21 mins ago
Software Engineer II - AVI MIL FMS (Onsite)
RTX
United States
Collins Aerospace is currently seeking qualified candidates for Software Engineer II roles in our Military Avionics Flight Management department located in Cedar Rapids, Iowa. Teams are…
Added 24 mins ago
Software Engineer II - DevOps / Infrastructure (Onsite)
RTX
United States
Take ownership of the program’s CI/CD pipeline, optimizing code integration and delivery of the simulation environment.
Added 24 mins ago
Senior Software Engineer - Agile Product Owner (Onsite)
RTX
United States
Senior Software Engineer - Agile Product Owner - Flight & Mission Simulation (Onsite)
Added 24 mins ago
Software Engineer II - Test Solutions Center
RTX
United States
The Software Engineer II - Test Solutions Center position is focused on the design, development, integration, and maintenance of software as a part of on-site factory support of systems to…
Added 24 mins ago
Software Quality Engineer onsite Woburn, MA
RTX
United States
Our team in Woburn has an immediate need for a Software Quality Engineer for the Strategic Upper Tier Missile Defense Agency/Sensors & Precision Strike (SSPS) section within the Air & Space…

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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