Lead Systems Engineer

2 weeks ago

Bothell, Washington, United States Bausch Health Full time

Company Overview: Solta, a division of Bausch Health, is dedicated to enhancing patients' quality of life through advanced technology that combines sophistication with simplicity, offering genuine aesthetic and therapeutic advantages. For over ten years, we have been pioneering innovative treatment technologies that deliver effective aesthetic care solutions for both consumers and healthcare professionals.

Position Summary: The Principal Systems Engineer plays a crucial role in ensuring that Solta products fulfill functional system requirements. This position involves coordinating the activities related to system-level specifications, testing, and development of medical device products within the aesthetic domain. The ideal candidate will be a proactive self-starter, capable of collaborating effectively with a multidisciplinary product development team while adhering to standards such as IEC14971, IEC 60601, and ISO.

Reporting Structure: Reports to the Senior Manager of Product Development.

Key Responsibilities:

  • Provide mentorship and guidance to junior engineers.
  • Develop and manage system functional requirement specifications, along with conducting risk management and assessments.
  • Establish and maintain product requirements traceability using a requirements management database tool (e.g., DOORS NG or Visure).
  • Ensure verification tasks are traceable to product functional requirements.
  • Engage in defect tracking and resolution processes.
  • Offer technical leadership to various engineering disciplines to ensure requirements are effectively communicated to component-level designs.
  • Collaborate cross-functionally with other departments to ensure compliance with regulatory and quality standards.
  • Identify test cases and create verification test protocols for both software and hardware, utilizing manual and automated testing methods.
  • Occasionally coordinate specialized engineering test tasks, such as HALT.
  • Be open to occasional travel for short-duration assignments.
  • Lead risk assessment and management initiatives for both new designs and existing products.
  • Demonstrate a desire and capability to troubleshoot system-level issues using systematic approaches and failure analysis techniques.

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 or a closely related field.
  • Proficient knowledge and experience in System Engineering principles, with a proven history of successful leadership in system engineering projects and mentorship.
  • Experience with energy-based delivery devices and familiarity with preclinical and clinical studies.
  • Ability to support project planning and management, including proficiency in scheduling software such as MS Project.
  • Demonstrated experience using requirements management tools (e.g., DOORS) for effective requirements tracking.
  • Strong focus on achieving scheduled milestones and utilizing defect tracking tools like JIRA.
  • In-depth knowledge of FDA Quality System and Design Control requirements, applicable from design inception to manufacturing release.
  • Regulatory experience with QSM and ISO13485 standards.
  • Expertise in risk management techniques in accordance with EN 14971, EN IEC /-2, EN IEC 62304, and MDD / MDR Essential Requirements.
  • Experience in supporting Usability Engineering activities compliant with EN IEC 62366.
  • Ability to produce designs that meet basic safety and essential performance criteria, including EMC-related events per EN IEC /-2.
  • Excellent team collaboration and communication skills, with a demonstrated ability to synthesize input from various cross-functional engineering experts.
  • Proactive in overcoming obstacles and time constraints, with a willingness to assist wherever necessary.
  • Proven ability to manage multiple tasks effectively.

Language and Communication Skills: Proficient in reading, analyzing, and interpreting engineering specifications, business publications, professional journals, technical procedures, and governmental regulations. Capable of writing reports, specifications, business correspondence, test plans/protocols, and procedure manuals. Able to effectively present information and respond to inquiries from peers, managers, executives, system users, and suppliers.

Mathematical and Analytical Skills: Competent in working with mathematical concepts such as probability and statistical methods, and skilled in using basic engineering tools for calculations and simulations. Able to define problems, collect data, establish facts, and draw valid conclusions.

Physical Requirements: The role may require lifting tasks of up to 10 pounds for short durations and using a computer for extended periods. Duties may also involve standing and/or walking for prolonged periods.

Work Environment: The typical noise level in the work environment is moderate, with some light machining and prototyping activities potentially involving moderate noise and dust exposure.

Safety Commitment: Solta prioritizes the health and safety of its employees, expecting all team members to perform their responsibilities while maintaining a safe, cooperative, and productive work environment.

Compensation and Benefits: Bausch Health offers a competitive compensation range for this role, influenced by various factors including skill set and experience. The benefits package includes comprehensive medical, dental, and vision coverage, along with a 401(k) matching program, paid time off, employee stock purchase plans, and various other benefits.

Equal Opportunity Employer: Bausch Health Companies Inc. is an Equal Opportunity Employer, committed to building diverse teams that reflect the patients and communities we serve, and fostering an inclusive workplace.

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