Lead Systems Engineer

2 weeks ago

Bothell, Washington, United States Bausch Health Full time

Company Overview: Bausch Health is dedicated to enhancing patient quality of life through innovative medical technologies and aesthetic solutions. Our commitment to excellence has positioned us as a leader in the medical device industry, particularly in aesthetic care.

Position Summary: The Principal Engineer will play a pivotal role in ensuring that our products meet stringent functional system requirements. This position involves overseeing system-level specifications, testing, and development of medical devices within the aesthetic sector. The ideal candidate is a proactive self-starter who thrives in a collaborative environment with a diverse product development team, adhering to standards such as IEC14971, IEC 60601, and ISO.

Reporting Structure: This role reports directly to the Senior Manager of Product Development.

Key Responsibilities:

  • Provide guidance and mentorship to junior engineers.
  • Develop and manage specifications for system functional requirements, including risk management assessments.
  • Maintain product requirements traceability using management tools like DOORS NG or Visure.
  • Ensure verification tasks are aligned with product functional requirements.
  • Engage in tracking and resolving defect issues.
  • Offer technical leadership across engineering disciplines to ensure requirements are effectively translated into component designs.
  • Collaborate cross-functionally to ensure compliance with regulatory and quality standards.
  • Identify and document test cases, writing protocols for software and hardware verification.
  • Occasionally coordinate specialized engineering tests.
  • Willingness to travel for short-term assignments as needed.
  • Lead risk management initiatives for both new and existing products.
  • Utilize systematic approaches to troubleshoot complex system-level issues.
Qualifications:
  • Bachelor's or Master's degree in Engineering or a related field, with a minimum of 10 years of experience in developing, validating, and testing complex electro-mechanical systems, including at least five years in the medical device sector.
  • Proven expertise in System Engineering principles and successful leadership in system engineering projects.
  • Experience with energy-based delivery devices and familiarity with preclinical and clinical evaluations.
  • Ability to support project planning and management using tools like MS Project.
  • Demonstrated experience with requirements management tools.
  • Strong focus on achieving project milestones.
  • Experience with defect tracking systems.
  • Knowledge of FDA Quality System and Design Control requirements.
  • Experience with risk management techniques in compliance with relevant standards.
  • Strong communication and collaboration skills, with the ability to synthesize input from various engineering experts.
  • Ability to manage multiple tasks effectively.
Skills and Abilities:
  • Strong analytical skills with the ability to interpret complex technical documents.
  • Proficient in mathematical concepts and engineering tools for calculations and simulations.
  • Ability to define problems, collect data, and draw valid conclusions.
  • Capacity to read and interpret technical literature and extract key concepts.
Work Environment: The work environment is typically moderate in noise level, with some exposure to light machining activities.

Commitment to Safety: Bausch Health prioritizes the health and safety of all employees, fostering a cooperative and productive work environment.

Compensation and Benefits: Bausch Health offers a competitive compensation package, including comprehensive medical, dental, and vision coverage, along with various other benefits designed to support employee well-being and professional growth.

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