Jobs in the United States

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Added 1 min ago
RF/Microwave Engineer, Satellites (Starlink)
SpaceX
Redmond, WA
…internet to millions of users worldwide. We design, build, test, and operate all parts of the system – thousands of satellites, consumer receivers that allow users to connect within minutes…
Added 1 min ago
Electronic Design Engineer, Satellites (Starlink)
SpaceX
Redmond, WA
As an Electrical Design Engineer on Starlink, you’ll have ownership over the entire life-cycle of the hardware that enables this connectivity, and sits at the intersection of electrical,…
Added 1 min ago
Electrical Hardware Engineer, Satellites (Starlink)
SpaceX
Redmond, WA
As an Electrical Design Engineer on Starlink, you’ll have ownership over the entire life-cycle of the hardware that enables this connectivity, and sits at the intersection of electrical,…
Added 1 min ago
Electrical Engineer, Satellites (Starlink)
SpaceX
Redmond, WA
As an Electrical Design Engineer on Starlink, you’ll have ownership over the entire life-cycle of the hardware that enables this connectivity, and sits at the intersection of electrical,…
Added 1 min ago
Senior Research Prototyping Engineer
Bose Corporation, U.S.A
MA
Bose is seeking a hands-on engineer to build and evaluate experimental systems combining devices, software and research-developed algorithms. Working in a multidisciplinary research team,…
Added 2 mins ago
Senior Lead Design Engineer - RTL Design
Altera Corporation
San Jose, CA
…concept through RTL delivery, verification, implementation, hardware validation, and product readiness. The successful candidate combines deep RTL design expertise with sound systems…
Added 3 mins ago
SysDev Engineer, Amazon Leo
Amazon Kuiper Commercial Services LLC
Bellevue, WA · Arlington, VA
As a System Development Engineer III at Amazon Leo Global Business & Customer Operations ASTRA team (Agentic Surfaces, Tools & Resource Access), you will own platform reliability and…
Added 4 mins ago
Senior Automation Engineer
Novo Nordisk
Bloomington, IN
The Senior Automation Engineer (IT Automation) provides technical expertise in process automation and control systems, supporting site operations through the design, maintenance,…
Added 7 mins ago
IG
Quality Engineer I
Insight Global
Maple Grove, MN
- From $26 USD / hour
Experience with laboratory testing, data acquisition systems, National Instruments hardware, or related test equipment.
Added 8 mins ago
Software Engineer (Innovation Lab, North Reading)
Teradyne
North Reading, MA
As an Innovation Lab Software Engineer in North Reading, MA, you will develop software supporting hardware product systems and instrumentation within Teradyne’s Semiconductor Test Division.…
Added 8 mins ago
CMP Equipment Install Engineer
Samsung Austin Semiconductor, LLC.
1530 FM 973 Taylor, TX
PLC & Control Logic: Basic knowledge of Programmable Logic Controllers (PLCs) to verify that the software is communicating correctly with the hardware.
Added 9 mins ago
PI
Powertrain Calibration Lead Engineer
Polaris Industries Inc.
MN
- $80,000 to $105,000 USD / year
Partner with module leads and design, development, validation, project management, and executive stakeholders to ensure hardware and calibration systems meet program objectives.
Added 9 mins ago
KC
Associate Test Engineer, Analytical Instrumentation
KLA Corporation
Milpitas, CA
- $28.85 to $49.04 USD / hour
Strong mechanical aptitude and comfort working with laboratory hardware, experimental setups, and test systems.
Added 14 mins ago
Telecommunications LMR Systems Engineer
Boyd Gaming
Las Vegas, NV
The IT Telecommunications & LMR (Land Mobile Radio) Systems Engineer provides hands-on operational support, engineering, maintenance, troubleshooting, and lifecycle management for…
Added 16 mins ago
Low Latency Trading Infrastructure Engineer
Citibank, N.A.
United States
The Low Latency Trading Infrastructure Engineer is a rare combination of deep technical specialist and mission-critical operator - a professional whose expertise sits at the intersection of…
Added 19 mins ago
Mid Career Spaceflight Hardware Propulsion Engineer
Mclaurin Aerospace
Houston, TX
We have an exciting opportunity for a Mid Career Spaceflight Hardware Propulsion Engineer to join our JETS II contract team at NASA Johnson Space Center in Houston, TX.
Added 19 mins ago
Mechanical Design Engineer
Mclaurin Aerospace
Houston, TX
Design, develop, test, analyze, and implement technical products and systems
Added 19 mins ago
Early Career Spaceflight Hardware Propulsion Engineer
Mclaurin Aerospace
Houston, TX
We have an exciting opportunity for a Early Career Spaceflight Hardware Propulsion Engineer to join our JETS II contract team at NASA Johnson Space Center in Houston, TX.
Added 19 mins ago
Principal Engineer - Integration, Test, & verification
Firestorm
United States
Build and lead a cross-product integration, test, and verification capability for complex hardware/software/UAS systems. Own the integration and verification approach, test architecture,…
Added 21 mins ago
RF Electrical Engineer (R&D Engineer 1/2)
Los Alamos National Laboratory
Los Alamos, NM
…assemblies, design, fabrication, qualification, and installation of test fire control systems, pulse power engineering, advanced detonator design and testing, and applied problem solving.…
Added 21 mins ago
Cleared Senior/Principal RD Systems Engineer - Mobile Guardian Transporter Quality, Hybrid
Sandia National Laboratories
Albuquerque, NM
Experience in designing and qualifying hardware, software, and test equipment
Added 21 mins ago
Cleared Senior/Principal RD Systems Engineer - Surety Systems Engineering, Onsite
Sandia National Laboratories
Albuquerque, NM
The 2910/2920 Surety Systems Engineer (SSE) develops, implements, and maintains strategies to lead the R&D project team in successful product qualification and delivery. SSEs interface…
Added 25 mins ago
Sr. Engineer, Vehicle Dynamics
Lucid Motors
Newark, CA
As a Senior Engineer in Vehicle Dynamics Development you will support the testing, tuning, development and validation of the best riding and handling vehicles in the world. You will work…
Added 26 mins ago
Engineer- Controls II USA
LED FastStart
New Iberia, LA
…global implementation and development of electrical controls systems/designs, PLC/HMI programing, perform vendor equipment check-out, equipment/system start-ups, data collection and…
Added 26 mins ago
W
Applications Engineer 4 – DevOps
Wyetech
Linthicum Heights, MD
- $91.22 to $123.52 USD / hour
Enhance, modify, and test COTS/GOTS and any applicable hardware to ensure interoperability and compatibility with existing Enterprise IT/IC GovCloud architecture; prepare Engineering Change…

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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