Principal Engineer

3 weeks ago

Bothell WA USA, United States Bausch Health Full time
Job Description

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. For more than a decade, we've been developing innovative treatment technologies to provide proven and effective aesthetic care options to consumers and physicians alike.

Job Summary

The Principal System Engineer confirms Solta products meet functional system requirements, coordinates activities involved in system level specification, testing, and development for medical device products in the aesthetic space. The applicant must be a hands-on self-starter, who is able to work collaboratively with a multi-disciplinary product development team in accordance with the standards IEC14971, IEC 60601, and ISO 13485.

Key Responsibilities
  • Provide mentorship/leadership to less experienced engineers.
  • 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 (e.g., DOORS NG or Visure).
  • 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 (with other departments outside R&D) 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 that use both manual and automated test methods.
  • Infrequently coordinate special engineering test tasks; e.g., HALT.
  • Be willing to travel occasionally for short duration trips.
  • Able to lead risk assessment/management efforts for both new designs and existing products.
  • Desire and ability to troubleshoot system level problems using a systematic approach/using failure analysis techniques.
Requirements
  • BS or MS in Engineering or related discipline plus at least 10 years of experience developing/validating/testing complex electro-mechanical systems, and 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.
  • 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 on the use of a requirements management tool (e.g., 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, ISO13485.
  • Risk Management techniques and experience in EN 14971, EN IEC 60601-1/-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 60601-1/-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.

Safety

Solta is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.

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