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.
Description: 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.
Reports To: Sr. Manager, Product Development
Principle Responsibilities and Duties:
Note: The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.
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 & ability to troubleshoot system level problems using a systematic approach / using failure analysis techniques.
Experience, Education, Training, Traits:
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.
Analytical and Reading Skills
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to read technical and clinical literature and documents and extract important concepts.
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.
As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is $110K to $160K per year.
Benefits package includes a 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 (unless a state or city-specific policy applies) to start (pro-rated for new hires), 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 (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.
This position may be available in the following location(s): US - Bothell, WA
We thank you in advance for your interest in growing and developing with our company. Kindly note that in order for all stakeholders to be successful, we do require a minimum of one year in your current role before applying to another one. Please ensure you have discussed with your current manager the intent of applying to a new role.
Any exception will have to be authorized by your HR Business Partner.
We are 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. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.
If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to humanresources@bauschhealth.com or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.
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