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 has the ability to work collaboratively with a multi-disciplinary product development team in accordance with the standards IEC14971, IEC 60601, and ISO 13485.
Note: The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.
- Formulate and manage system functional requirement specifications, risk management and risk assessments.
- Establish and maintain product requirements trace management via DOORS NG database tool.
- Ensure traceability of verification tests 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 with other departments 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 utilize manual and automated test methods.
- 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.
- Infrequently coordinate special engineering test tasks; e.g. HALT
- Be willing to travel occasionally for short duration trips
- BS or MS in Engineering or related discipline plus 7 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 and proven track record of successful leadership with system engineering projects
- Experience with energy-based delivery devices
- Experience with preclinical and clinical studies and evaluations
- Working knowledge of project planning and management
- Demonstrated experience on the use of a requirements management tool (e.g. DOORS/DOORS NG) for requirements management
- Ability to focus on and achieve scheduled milestones, including contingency planning.
- 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 QSM, ISO13485.
- Risk Management techniques and experience in EN 14971, EN IEC 60601-1/-2, EN IEC 62304, MDD / MDR Essential Requirements.
- Experience in Usability Engineering 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.
- 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.