Biomedical Engineer (Product Development)

Aversan, Inc. ( www.aversan.com ) is a reputable engineering company that provides expertise in the aerospace and defense industries.

We are currently seekingaqualified System Engineer for our client recently certified as a Great Place to Work for the second consecutive year, is a fast-growing disruptive medical device startup company.

The System Engineer with strong technical leadership capabilities to lead our talented teams across diverse domains such as optics, mechanical, electrical, software, and machine learning.

As the key figure in our projects, you will play a pivotal role in providing technical guidance throughout the entire development lifecycle, overseeing planning, design, implementation, and maintenance phases

Responsibilities :

• Providing technical leadership and oversight of diverse, distributed teams of engineers in development of complex medical device software, optics, electronics, mechanics and ML from concept initiation to product release
• Translating customers unmet needs into actionable user and system technical-level requirements, supporting platform architectures, and associated project execution plans
• Translating highly technical analysis to easily understood recommendations and design alternatives that will influence senior stakeholders.
• Work across multidisciplinary teams to create, verify, manage, and track system- and subsystem-levels of requirements and specifications.
• Demonstrating leadership and advanced knowledge of PLC, and SDLC methodologies
• Plan and oversee tasks breakdown and execution within the projects’ teams, designated projects and account for the project development execution in quality and on time.
• Work with development teams to support risk analysis, risk management, FMEAs, and identify proper risk mitigation solutions to the system and subsystems.
• Provide technical leadership in system integration, testing, verification, problem solving and improvements.
• Oversee and be deeply acquainted with development processes regulated by relevant standards. Such as applicable medical device safety, risks management, usability etc.
• Overseeing systems design and documentation meet all safety and regulatory compliance.
• Hands-on work on the system driving new functionality.
• Attend animal and bench-testing labs for both R&D hands-on and / or clinical observations as part of clinical expertise required for system characterization.
• Support key processes in the development life cycle, such as : sustainability, failure investigations, SW optimization, technical experiments, Risk management process, usability validation and UI / UX specifications
• Provide technical leadership and guidance to the development team, ensuring adherence to best practices, and architectural principles.

Qualifications

• B.Sc. or M.Sc. from a known institute in the fields of : Biomedical / electrical / Software / robotics / algorithms or Systems engineering
• Experience through full product development cycle of complex medical device systems, or other regulated fields, from initial concept to product release.
• Demonstrated technical leadership and ownership.
• Proven ability of analytical problem solving and troubleshooting
• Ability to provide guidance and direction to less experienced technical personnel.
• Track record of strong cross-functional collaboration, influence without authority, and project management enabling highly effective project teams
• Self-driven, Can-Do attitude (a kick-starter)
• 3+ years of hands-on technical / + development experience (Electrical / SW / Biomedical / mechanical / robotics / optics)
• Experience in leading a cross-functional technical challenge.
• Great team player with engagement creation skills
• Fluent in technical English verbal & written.
• Ability for travel up to 20% of the time

Nice to Haves

• 2+ years of work experience as a technical team leader or system Eng. in medical devices or other highly regulated industries big advantage
• System engineering of a complex medical device experience big advantage
• SW / HW / Algo characterization and requirements writing big advantage.
• Development experience in a regulated environment advantage
• System performance modeling, simulation, and test (python, MATLAB ) -advantage
• Global company experience - advantage
• Image processing background - advantage

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