Lead Systems Engineer at Solta

2 weeks ago

Bothell, Washington, United States Bausch Health Full time

Company Overview: Solta, a division of Bausch Health, is dedicated to enhancing the quality of life for patients through the delivery of advanced technology in streamlined, aesthetically pleasing designs that offer genuine therapeutic and aesthetic advantages. With over a decade of experience, we have been at the forefront of developing innovative treatment technologies that provide effective aesthetic care solutions for both consumers and healthcare professionals.

Position Summary: The Principal Systems Engineer is responsible for ensuring that Solta products fulfill functional system requirements. This role involves coordinating the activities related to system-level specifications, testing, and development of medical device products within the aesthetic sector. The ideal candidate is a proactive self-starter who thrives in a collaborative environment with a multidisciplinary product development team, adhering to standards such as IEC 14971, IEC 60601, and ISO.

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

Key Responsibilities:

  • Provide mentorship and guidance to junior engineers.
  • Develop and manage system functional requirement specifications, including risk management and assessments.
  • 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 other 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.
  • Be open to occasional travel for short durations.
  • Lead risk assessment and management efforts for new designs and existing products.
  • Demonstrate a systematic approach to troubleshooting system-level issues using 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 industry or a closely related field.
  • Strong knowledge of System Engineering principles and a proven track record of successful leadership in system engineering projects.
  • Experience with energy-based delivery devices and familiarity with preclinical and clinical studies.
  • Proficient in project planning and management, including the use of scheduling software such as MS Project.
  • Experience with requirements management tools (e.g., DOORS) and defect tracking tools (e.g., JIRA).
  • Knowledge of FDA Quality System and Design Control requirements, as well as regulatory experience in QSM and ISO 13485.
  • Familiarity with risk management techniques and standards such as EN 14971 and EN IEC 62304.
  • Strong collaboration and communication skills, with the ability to synthesize input from various engineering experts.
  • Ability to manage multiple tasks effectively and demonstrate a commitment to overcoming challenges.

Language and Analytical Skills:

The candidate must possess the ability to read, analyze, and interpret engineering specifications and technical documents. Strong writing skills are essential for creating reports, specifications, and test plans. The candidate should also be capable of effectively presenting information and responding to inquiries from various stakeholders.

Physical and Work Environment:

The role may require lifting tasks of up to 10 pounds and prolonged computer use. The work environment typically features moderate noise levels, with some exposure to light machining and prototyping activities.

Commitment to Safety:

Solta prioritizes the health and safety of its employees, fostering a safe and productive work environment.

Compensation and Benefits:

Bausch Health offers a competitive compensation package, influenced by factors such as skill set and experience. The benefits package includes comprehensive medical, dental, and vision coverage, along with a 401(k) matching program, paid time off, and various employee assistance programs.

Diversity and Inclusion:

Bausch Health is an Equal Opportunity Employer, committed to building diverse teams that reflect the communities we serve. We strive to create an inclusive workplace that promotes collaboration and respect.

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