Director of Engineering, Chief Engineer

Boston, MA · Job # 8943BK

Overview

Our client is seeking a Director of Engineering, Chief Engineer to manage the system-level development and commercialization of new products while facilitating the resolution of issues and improvements of our medical device platforms in the field.  The position will be responsible for establishing the technical scope, timeline, resource planning and budgets for the system engineering efforts while overseeing the technical execution of the engineering programs.

Responsibilities

  • Grow and manage an engineering team that consists of system architecture, system engineering and system-level testing functional groups
  • Create and oversee the implementation of the architecture and technical design of new products in development
  • Facilitate the resolution of technical issues and improvements of product that is in the field
  • 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
  • Facilitate progress with the right mix of Agile methods and Waterfall deliverables, resulting in an efficient and fast pace of progress
  • Establish and enforce good system engineering practices for deliverables including system requirements, architecture and design descriptions and system-level test methods and protocols
  • Serve as a primary technical interface with external product development customers
  • Interface with the hardware and software design leads to ensure system architecture is translated into system design
  • 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
  • Maintain and project a positive attitude on the state of the union and the team’s progress
  • Ensure system deliverables are consistent with our Quality Management System in support of regulatory submissions
  • Contribute to technical summaries and resource estimates during RFP generation for new projects

 

Education, experience and skills required

  • Relevant engineering degree, advanced degree preferred
  • Minimum of 15 years’ experience with system-level product design
  • Minimum of 10 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 creating and implementing patient safety systems that are compliant with applicable standards and regulations
  • Mastery of relevant system engineering tools
  • 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

 

Company will sponsor a VISA candidate

 

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