Principal Engineer Aesthetic Medical Device (Bothell, WA)

Principal Engineer Aesthetic Medical Device (Bothell, WA)

Job Location:

Bothell, Washington, USA Job Requisition ID:

14329 Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it-where your skills and values drive our collective progress and impact. The Principal Systems/Verification Engineer confirms Solta products meet functional system requirements. The applicant must be a hands-on self-starter, who has the ability to work collaboratively with a multi-disciplinary product development team in support of all aspects of component and systems level verification testing of medical devices. This person will develop and manage component and system level testing consistent with product system requirements in accordance with the Company, applicable standards (e.g.

IEC14971, IEC60601, & ISO13485

), FDA and other requirements, identifying and developing test methods and individual test cases across multiple products;

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.

• Develop System/SW verification Tests using C, C++ and C#
• Develop tests for device software, including automated tests.
• Lead / participate in Design and Code reviews
• Demonstrated experience with Medical Device System/SW verification for Windows CE based devices and Embedded Linux based devices.
• Coordinate / conduct Design Verification testing (embedded Linux / C#)
• Provide technical leadership / mentoring - especially in applicable test methods of products
• Develop plans and coordinate activities for system level verification testing, including regression analysis of system functionality to determine scope of testing, overseeing test execution and reviewing individual test results and data for inclusion with test reports.
• Write individual and summary level test reports which provide clear and concise results along with appropriate detail information as needed.
• In partnership with other system engineers, formulate system functional requirement specifications and risk assessments.
• Establish and maintain product requirements and verification trace management via a requirements management tool.
• Identify test cases and write verification test protocols for software and hardware verification/validation that utilize manual and automated test methods.
• Design and/or develop verification scripts to utilize automated test methods
• Develop verification test scripts and protocols utilizing automated and manual test methods.
• Address and analyze functionality and performance related issues discovered during verification testing.
• Document results of work activities.
• Participate in defect issue tracking, troubleshooting, and resolution.
• Identify and isolate product defects, perform root cause analysis, and work with engineering team across design disciplines to determine corrective action.
• Work closely with other departments to ensure projects conform to all regulatory and quality regulations.
• Stay up-to-date and follow all procedures related to this job that can affect the quality of products or services provided to our customers.
• Be willing to travel occasionally for short duration trips

Experience, Education, Training, Traits:

• BS or MS in Engineering plus 10 years of experience designing / validating / testing of complex electro-mechanical systems, and at least five years in medical devices or closely related field.
• Knowledge / experience in System Engineering concepts/principles.
• Experience with C# and .NET desired
• Verification experience with embedded platforms including Windows CE and Embedded Linux desired
• Proven track record of successful product testing, verification, and validation using a variety of testing tools and techniques.
• 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/DOORS NG

) for requirements trace management

• Ability to focus on and achieve scheduled milestones, including contingency planning.
• Ability to operate test equipment such as oscilloscope, logic analyzer, etc.
• Competency in at least one of the following: C++, C#, Visual Basic, or Matlab.
• Use of defect tracking tools such as TestTrack, JIRA, etc.
• Knowledge of FDA Quality System and Design Control requirements and their application to projects from design inception to manufacturing release.
• Regulatory experience in

QSR, ISO13485.

• Risk Management techniques and experience in

EN 14971

,

• Experience in Usability Engineering compliant to

EN IEC 62366

.

• Experience producing designs compliant to

EN IEC 60601-1 /-2

, EN

IEC 62304

Medical Device Directive Essential Requirements. Working experience with ESD environment.

• Strong team collaboration and communication skills.
• 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 groups of managers, clients, customers, and the general public. 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 inference, and fundamentals of plane and solid geometry and trigonometry. 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 Duties of this job may involve standing and/or walking for extended periods of time. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision and color vision. 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. The range of starting base pay for this role is $115K-158K. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan. Benefits package includes a comprehensive Medical (includes Prescription Drug), Dental, Vision, , Flexible Spending Accounts, 401(k) with matching company contribution, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term and long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, employee referral bonuses and employee discounts. We are an Equal Opportunity Employer. EOE Disability/Veteran. 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.