Senior Systems Engineer

6 days ago

Bothell, Washington, United States Bausch Health Full time
Job Description

Job Summary: We are seeking a highly skilled and experienced Senior Systems Engineer to join our team at Bausch Health. As a key member of our product development team, you will be responsible for ensuring that our medical device products meet the highest standards of quality and safety.

Key Responsibilities:

  • Provide technical leadership and mentorship to junior engineers
  • Develop and manage system functional requirement specifications, risk management, and risk assessments
  • Establish and maintain product requirements traceability via a requirement management database tool
  • Ensure traceability of verification tasks to product functional requirements
  • Participate in defect issue tracking and resolution
  • Provide technical leadership to other engineering disciplines to ensure requirements flow down to component level designs
  • Work closely with cross-functional teams to ensure projects conform to all regulatory and quality regulations
  • Identify test cases and write verification test protocols for software and hardware and usability verification/validation
  • Coordinate special engineering test tasks, such as HALT
  • Travel occasionally for short duration trips
  • Lead risk assessment and management efforts for new designs and existing products
  • Troubleshoot system level problems using a systematic approach and failure analysis techniques

Requirements:

  • BS or MS in Engineering or related discipline plus at least 10 years of experience developing, validating, and testing complex electro-mechanical systems, and at least five years in medical devices or closely related field
  • Knowledge and experience in System Engineering concepts and principles, and proven track record of successful leadership with system engineering projects and mentorship with system engineers
  • Experience with energy-based delivery devices
  • Experience with preclinical and clinical studies and evaluations
  • Ability and willingness to support project planning and management, including use of scheduling software such as MS Project
  • Demonstrated experience with a requirements management tool, such as DOORS, for requirements management
  • Ability to focus on and achieve scheduled milestones
  • Use of defect tracking tools, such as JIRA
  • Knowledge of FDA Quality System and Design Control requirements and their application to projects from design inception to manufacturing release
  • Regulatory experience in QSM, ISO 13485
  • Risk Management techniques and experience in EN 14971, EN IEC 62304, MDD/MDR Essential Requirements
  • Experience in supporting Usability Engineering activities compliant to EN IEC 62366
  • Experience producing designs compliant to basic safety and essential performance, including EMC-related events per EN IEC 60601-2
  • Strong team collaboration and communication skills, and demonstrated ability to synthesize input from various cross-functional engineering subject matter experts
  • Driven to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed
  • Demonstrated ability to multi-task

Language and Verbal Skills:

  • Ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, or governmental regulations
  • Ability to write reports, specifications, business correspondence, test plans/protocols, and procedure manuals
  • Ability to effectively present information and respond to questions from peers, managers, executives, system users, and suppliers
  • Ability to clearly and concisely convey project accomplishments, obstacles, issues, and status to project team members

Math Skills:

  • Ability to work with mathematical concepts such as probability and statistical methods, as well as ability to use basic engineering tools to perform calculations and simulations and interpret project results/data

Physical Requirements:

  • While performing the duties of this job, the employee may be required to perform lifting tasks of up to 10 pounds for short durations
  • The employee will be required to use a computer for up to 8 hours consecutively and may also involve daily keyboard data entry
  • Duties of this job could include standing and/or walking for extended periods of time

Work Environment:

  • The noise level in the work environment is usually moderate
  • Some light machining and prototyping activities will involve moderate noise levels (i.e. power drill) and moderate dust or debris exposure

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