Prinical Systems Engineer, Development

Location
Remote Worker - N/A
Category
Full-time
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Description

The Principal Systems Engineer will lead the design and development of new medical devices for significant portions of a development program, navigating through high levels of ambiguity. They will take charge of planning, documenting, and executing design and development efforts for new medical devices, platform technologies, and improvements to existing devices. This role will serve as a mentor to less senior team members. This individual is expected to have a strong technical background and will work collaboratively across functions and geographical locations to bring systems from concept to launch.


PRIMARY RESPONSIBILITIES

  • Define, design, and lead the overall development of system architecture, design control elements, and integration of new product development efforts
  • Interface directly with key opinion leaders, key customers, and end-users to lead the translation of user needs into effective system requirements, ensuring compliance with current and emerging industry standards, and overseeing end-to-end traceability between user needs, requirements, test, and risk
  • Ensure the safety, reliability, and performance of the complete system and sub-systems, considering elements like human factors, biocompatibility, sterilization, and design tradeoffs to arrive at detailed product level and functional specifications
  • Engage in risk management activities for new product development in compliance with ISO 14971
  • Provide expertise and conduct comprehensive verification and validation of design outputs to ensure the final product meets the intended design and performance specifications
  • Manage complex and large-scale development efforts with external partners to achieve business objectives
  • Guide technical cross-functional project teams on multiple new product design and development projects, successfully influencing stakeholders
  • Develop and maintain design history file and related documentation
  • Collaborate with Program Management to provide clear updates on project status, technical risk, and factors impacting program success
  • Support product launches, clinical, and commercial use of existing and new products


ADDITIONAL RESPONSIBILITIES

  • Mentor more junior engineers; may supervise or manage engineers 
  • Support post-market (commercial) product-related investigations as well as CAPA and sustaining engineering activities
  • Identify opportunities for process improvement and contribute to the development of best practices
  • Champion and understand the needs of the patient, provider, and business through an unwavering commitment to patient safety and product quality
  • Lead efforts in identifying and obtaining extramural funding (e.g. grants, contracts, etc.) to support device development projects
  • Support development of intellectual property critical to the company’s success 
  • Perform other related duties as assigned
Requirements

KNOWLEDGE AND SKILL REQUIREMENTS 

  • 10+ years of experience (or equivalent combination of experience and education)
  • In-depth knowledge of medical device development, system engineering principles, and relevant technologies.
  • Strong understanding of FDA regulations and international standards for medical devices.
  • Proven experience in conducting risk assessments and implementing mitigation strategies in compliance with ISO 14971.
  • Demonstrated ability to manage complex development efforts, including coordination with external partners.
  • Effective leadership skills to guide and mentor less senior team members, with the ability to influence stakeholders.
  • Exceptional communication and interpersonal skills, with the ability to collaborate across functions and geographical locations.
  • Proficient in developing and executing comprehensive verification and validation plans.


WORKING CONDITIONS

  • Small office environment, electrical and mechanical prototyping labs.
  • Ability to effectively work in a "virtual environment" at home or at a centrally located office
  • Comfortable and productive working in and contributing to small engineering teams.
  • Manufacturing environments typical of assembled electrical medical devices
  • Ability to “get the job done” in a we-can-do environment, allowing for flexible hours, depending upon the project and/or customer needs
  • Periodic travel, such as supplier visits, can usually be well planned in advance.