Senior System Engineer

4 weeks ago

Bothell, Washington, United States Bausch Health Full time

Job Summary:

Solta, a division of Bausch Health, is committed to improving patients' quality of life by delivering sophisticated technology in simple, elegant designs, providing true aesthetic and therapeutic benefits.

As a Principal System Engineer, you will play a crucial role in ensuring that our medical device products meet functional system requirements, coordinate activities involved in system level specification, testing, and development.

Key Responsibilities:

  • Formulate and manage system functional requirement specifications, risk management, and risk assessments.
  • Establish and maintain product requirements trace management 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 in a cross-functional manner 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.
  • Infrequently coordinate special engineering test tasks.

Requirements:

  • BS or MS in Engineering or related discipline plus at least 10 years of experience developing/validating/testing complex electro-mechanical systems.
  • At least five years in medical devices or closely related field.
  • Knowledge/experience in System Engineering concepts/principles and proven track record of successful leadership with system engineering projects and mentorship with system engineers.
  • Experience with energy-based delivery devices, preclinical and clinical studies, and evaluations.
  • Ability and willingness to support project planning and management, including use of scheduling software.
  • Demonstrated experience on the use of a requirements management tool.
  • Ability to focus on and achieve scheduled milestones.
  • Use of defect tracking tools.
  • Knowledge of FDA Quality System and Design Control requirements and their application to projects from design inception to manufacturing release.
  • Regulatory experience in QSM, ISO13485.
  • Risk Management techniques and experience in EN 14971, EN IEC/-2, 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 & essential performance including EMC related events per EN IEC/-2.

Benefits:

  • Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, Discretionary paid time off plus 6 days paid sick time.
  • Employee Stock Purchase Plan, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating holidays), Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits, employee referral bonuses, and employee discounts.

Location:

This position may be available in the following location(s): US - Bothell, WA.

Bausch Health Companies Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

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