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Senior QA Engineer
Cross River
Remote, United States
We are looking for an experienced Senior QA Engineer who is passionate about building quality into software from the beginning, not simply testing it at the end. You will play a key role in…
Added 1 min ago
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Meeting Producer
AbbVie
North Chicago, IL
- $78,500 to $141,000 USD / year
If graphics operator or audio/video engineer is not available, provides onsite PowerPoint, Streaming and/or AV technical support.
Added 1 min ago
Cloud Engineer (Senior)
BAE Systems
Herndon, VA
Required Education, Experience, & Skills We are looking for an Senior Systems Engineer with a Bachelor's degree, 6 years of relevant work experience and a background utilizing the following:
Added 1 min ago
Hardware Engineer
BAE Systems
Nashua, NH
Job Description BAE Systems is seeking a senior technical engineer to assist in leading advanced program pursuits in a Hardware Engineering role. In this exciting role you will be assisting…
Added 1 min ago
Senior Staff Software Engineer_Voice AI Agent Prompting
ServiceNow
Santa Clara, CA
It all started when engineer Fred Luddy wrote code that automated a tedious task for his coworker, Phyllis. She cried tears of joy. That moment inspired Fred to build a company that could…
Added 1 min ago
Identity & Access Management (IAM) Engineer, Lead
Toyota
Plano, TX
Toyota Financial Services (TFS) is seeking an experienced Lead Identity and Access Management (IAM) Engineer to join our Information Security team. This role sets the technical direction…
Added 1 min ago
Sr. HVAC Engineer
Bechtel Corporation
Knoxville, TN
This position is for a Senior HVAC Engineer who will work on various projects as part of the NS&E execution center team. The projects that will be assigned involve government work…
Added 1 min ago
Civil Lead Engineer
Bechtel Corporation
Houston, TX
…phase at the SPL facility. It will consist of one liquefaction process train with a production capacity of approximately 5 MTPA; one boil-off gas reliquefaction unit; tie-ins to existing…
Added 1 min ago
Data Engineer
TVS Services, Inc.
Atlanta, GA
We're looking for a talented and experienced data engineer to join our team in Atlanta, Georgia. A Data Engineer at TVS plays an important role in TVS's success. Individuals in this role…
Added 1 min ago
Assistant Vice President, Electrical Engineering
WSP
Orlando, FL
WSP is currently initiating a search for an Assistant Vice President, Electrical Engineer for our Orlando, FL office location to help us grow our Property & Buildings office. This is an…
Added 1 min ago
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Cloud Engineer II (Full Time) - United States
Cisco
Milpitas, CA
- Full-time
Added 1 min ago
Solutions Engineer, Splunk
Cisco
Chicago, IL
Our Solutions Engineers are the technical heart of the sales process. We sit alongside account executives, own the technical relationship with our customers, and help them turn mountains of…
Added 1 min ago
SG
Mechanical Engineer IV
Smiths Group
Morton Grove, IL
- $115,398 to $144,247 USD / year
John Crane, a business of Smiths Group, is a global leader in mission-critical flow control solutions for energy and process industries that enable efficient and sustainable operations. Our…
Added 1 min ago
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Infrastructure Engineer III
Subaru
Camden, NJ
- $120,000 to $140,000 USD / year
Added 1 min ago
Scientist/Engineer, Biologics Technical Operations - Lilly Medicine Foundry
Eli Lilly and Company
United States
The Scientist/Engineer – Technical Operations becomes an expert in their assigned area, Small Molecule, Hybrid, or Biologics, and serves as a key integrator with Process Engineering,…
Added 2 mins ago
Field Engineer
Hoar
Dallas, TX
The Field Engineer is responsible to help facilitate project delivery and administrative requirements related to planning, management and communication through effective day-to-day…
Added 2 mins ago
Vulnerability Management Engineer
D2 Technical Services
St. Louis, MO
D2 Technical Services is committed to a merit-based recruitment process and encourages applications from all qualified individuals. As a Veteran-Owned Small Business, we particularly…
Added 2 mins ago
KC
Associate Test Engineer, Analytical Instrumentation
KLA Corporation
Milpitas, CA
- $28.85 to $49.04 USD / hour
We provide advanced inspection tools, metrology systems, process solutions, and computational analytics that make electronics possible, tackling complex challenges. From electron and photon…
Added 2 mins ago
Production Engineer
V2X
Indianapolis, IN
V2X Aerospace Solutions is seeking an engineer or technician with electrical background to support manufacturing and repair of Aerospace and Defense electrical and RF systems. The candidate…
Added 2 mins ago
Chief Engineer- Production
V2X
Indianapolis, IN
Role Overview: V2X is seeking a Production Chief Engineer within the Weapons System Integration (WSI) Team in Indianapolis, Indiana. The Production Chief Engineer (CE) serves as the primary…
Added 2 mins ago
Solution Architect – II – AWS / Agentic AI
INSPYR Solutions
Dallas, TX
No single candidate needs the full stack. The three hires together should cover it: one Rust-focused senior, one Python-focused senior, and a staff engineer who leans one way or the other.
Added 3 mins ago
Manufacturing Engineering Technician I - 3rd Shift
Bradford White Corporation
Middleville, MI
The Manufacturing Engineer Technician I performs various technical tasks associated with supporting manufacturing processes or equipment. Technical tasks include performance…
Added 3 mins ago
Quality Engineer
CGT U.S. Limited
TX
We are CURRENTLY seeking a Quality Engineer to join our growing team!
Added 4 mins ago
GPU Design Verification Engineer
ON, CA
Added 4 mins ago
GS
Director Consulting
Geocomp Solutions Inc.
United States
- $145,000 to $165,000 USD / year
Professional Engineer (PE) license - Geotechnical or Geostructural background required

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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