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Added 1 min ago
Senior Battery Structures Engineer
General Motors LLC
Warren, MI
As a Battery Structures Engineer within the New Products Engineering team, you will develop and mature battery enclosure and structural integration solutions for advanced vehicle…
Added 2 mins ago
Wireless RF OTA Connectivity Validation Engineer
Apple
Cupertino, CA · Santa Clara, CA
You will be part of a cross-functional team responsible for validating and certifying wireless performance across Apple's product portfolio. Working hands-on at the intersection of…
Added 3 mins ago
Precision Assembler
Flowserve US Inc
United States
Set up, stroke, calibrate, and function-test control valves and positioners to confirm proper travel, response, fail position, and operating performance.
Added 3 mins ago
ZG
Senior Software Engineer
Zeta Global
NY
- $193,461 USD / year
Zeta Global Corp seeks a Senior Software Engineer in NYC to design, develop, deploy, and own scalable distributed systems supporting the company’s customer relationship management and…
Added 3 mins ago
Q
Senior Advanced Semiconductor Packaging Engineer - 1119
Quantinuum
US Brooklyn Park, MN · US Malta, NY
- $147,000 to $197,000 USD / year
We are seeking a Senior Advanced Semiconductor Packaging Engineer to work either at one of our Minneapolis, MN sites or at a supplier site in Malta, NY as a full-time Quantinuum employee to…
Added 3 mins ago
Q
Manufacturing Engineer - 1108
Quantinuum
US Broomfield, CO
- $120,000 to $190,000 USD / year
We are seeking a Manufacturing Engineer in our Broomfield, CO, location.
Added 4 mins ago
Propulsion Systems Emissions Architect
Stellantis
Chelsea, MI
…software solutions in support of the production teams. The engineer acts as both an individual contributor and as part of teams within and outside of the ESD group and will be highly active…
Added 6 mins ago
Senior Cyber Data Capabilities Developer
Peraton
Fort Meade, MD
…analysis. Location: Fort Meade, MD. In this role, you will engineer software that transforms cyber telemetry into analytic outputs supporting authorized defensive and offensive cyberspace…
Added 7 mins 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 7 mins 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 7 mins 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 8 mins ago
Senior Lead Design Engineer - RTL Design
Altera Corporation
San Jose, CA
Altera is seeking a Senior Lead Design Engineer - RTL Design to provide hands-on technical leadership for the RTL architecture, design, integration, and delivery of next-generation FPGA and…
Added 9 mins ago
Software Development Engineer II, Robotics Development and Packaging Innovation
Amazon.com Services LLC
Bellevue, WA
As a Software Development Engineer on our team, you'll focus on building intelligent packaging deterministic workflows and large-scale platforms that power our packaging operations…
Added 9 mins ago
05487 - Electric Motor Design Engineer
Crafted Staff
Kalamazoo, MI
We are seeking an experienced Electric Motor Design Engineer to lead complex engineering assignments involving the electromagnetic design of AC and DC motors and the development of new or…
Added 9 mins ago
CS
05488 - Principle Engineer - Aerospace Research and Development
Crafted Staff
Kalamazoo, MI
- $130,000 to $160,000 USD / year
Principal Engineer – Aerospace Research and Development
Added 9 mins ago
Lead Mission Engineer - Full Stack
STR
Remote, United States
As a Mission Engineer (Full Stack) in the Mission Applications Group, you will develop and deploy software essential for a specific, real-world objective or "mission" in partnership with…
Added 9 mins ago
Software Engineer II - AI Platforms
Mastercard
Atlanta, GA
Mastercard is seeking a Software Engineer II to design, build, and enhance production-grade AI platform capabilities that enable AI-powered products and agentic experiences across B&MI.
Added 9 mins ago
Software Engineer II - AI Platforms
Mastercard
Atlanta, GA
Mastercard is seeking a Software Engineer II to design, build, and enhance production-grade AI platform capabilities that enable AI-powered products and agentic experiences across B&MI.
Added 10 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 12 mins ago
Principal Power Platform Engineer (R-19961)
Dun & Bradstreet
Center Valley, PA
The Principal Power Platform Engineer is responsible for designing and implementing intelligent, scalable and secure solutions built on Microsoft Power Platform with a strong focus on…
Added 12 mins ago
D&
Principal Power Platform Engineer (R-19961)
Dun & Bradstreet
Florham Park, NJ
- $147,000 to $247,000 USD / year
The Principal Power Platform Engineer is responsible for designing and implementing intelligent, scalable and secure solutions built on Microsoft Power Platform with a strong focus on…
Added 13 mins ago
IG
Quality Engineer I
Insight Global
Maple Grove, MN
- From $26 USD / hour
Insight Global is seeking a Quality Engineer I to support a leading medical device client in Maple Grove, MN. The Quality Engineer I will join an R&D Systems Test team supporting the…
Added 14 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 16 mins ago
Quality Engineer Senior
Mayville Engineering Co. Brand
Heber Springs, AR
…datum, and tolerances that affect fit, functions, durability, functional gauging, and product assessment. Conducts inspections and tests on products and materials to ensure they meet…
Added 16 mins ago
Principal Hardware Engineer (CRM)
MED Medtronic Inc
Tempe, AZ
…commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the…

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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