Sr. Manager, System Engineering (sustaining)

Sr. Manager, System Engineering (Sustaining)

Sr. Manager, Systems Engineering (Sustaining) will provide engineering leadership and hands-on contributions to maintain and enhance the performance of released products involving aesthetic laser systems and accessories. Sustaining engineering returns a system to its baseline configuration and capability and identifies opportunities for performance and capability enhancement. Life cycle economic analysis is performed to determine the relative costs and risks associated with the implementation of possible corrective and preventative actions. This position will manage a cross-functional engineering team interfacing with Marketing (GBU), Clinical, Service, Manufacturing, Regulatory, and Quality organizations when needed.

Essential Job Functions:

• Manage a cross-functional R&D Engineering team and work collaboratively with counterparts from the PMO, Service, Finance, Regulatory, Quality, Operations and the Global Business Unit (GBU) to provide design solutions that achieve organizational goals and stakeholder expectations for released products.
• Providing leadership to extended teams when applicable, including internal/external contractors and other engineering partners.
• Utilize systems engineering methodologies to ensure design solutions meet product requirements, managing and maintaining requirements for released products.
• Evaluate design tradeoffs using analytical system modeling or simulation techniques, manage design conflicts, and balance technical risks among cost, schedule, and performance while maintaining an acceptable level of risk covering the entire product life cycle.
• Work closely with functional leads in their respective fields to understand and meet design specifications.
• Coordinate engineering activities such as design, test, modification, fabrication and assembly of replacement electro-mechanical systems, candidate design circuitry, laser/light transmission devices or specialized test equipment using oscilloscopes, signal generators and specialized test apparatus.
• Oversee technical product risk assessment activities, in conjunction with the design, engineering test, and system verification teams to ensure that the integrity of mitigations remain intact.
• Collaborate with program management, engineering, and test teams to define engineering and system integration plans and acceptance criteria. Work hands-on with the team to characterize technical performance and track progress as designs solutions proceed through the verification process.
• Working closely with System V&V and Software Test Verification leads to establish test and traceability strategies that ensure coverage against requirements, monitor test results and defects, and generate final traceability reports, in compliance with design controls and all regulatory requirements.
• Address End-of-Life (EOL) issues by identifying replacement candidates and overseeing their implementation.
• Coordinate and oversee software releases to fix bugs, provide updates, and optimize performance.
• Use engineering tools to lead failure analysis or troubleshooting activities throughout the product life cycle to identify root causes and appropriate design improvements or actions for remediation.
• Prepare for and participate in comprehensive design reviews and technical reviews of subsystems or disciplines (e.g. electrical, software, mechanical, optical, etc.)
• Ensuring system risk management, requirements analysis, usability engineering, integration and test are driven with a robust, but lean approach.
• Periodic technical review of system performance, analysis of trends, and development of management options and resource requirements for resolution of identified issues.
• Provide periodic Sustaining Engineering metric reports to include: analysis of field complaints and maintenance data collected by the Quality and Service Teams reliability and maintainability trends.
• Operate Sustaining Engineering activities in an FDA regulated environment that meets internal quality requirements and regulatory standards for Class I/II medical devices (FDA 21 DFR 820.30, ISO 14791, IEC 62304, IEC 62366).

Knowledge/Educational Requirements:

• BS or MS (preferred) in electrical, mechanical, biomedical, or systems engineering
• 10+ years of post-undergraduate work experience in design and engineering of complex medical systems in a regulated environment. Engineering/technical leadership experience in a sustaining engineering and/or product support/development environment is preferred.
• Working knowledge of FDA, EU, IEC, AAMI, and ANSI standards relating to medical devices (e.g. ISO 13485, IEC 60601, IEC 60825, ISO 14971, ISO 10993, IEC 62366, FDQ QSR, EUMDR, etc.) is a plus
• Experience in creating DHF and technical file deliverables including system requirements, architecture, subsystem requirements, integration plans, risk analyses, and end-to-end traceability matrices
• Proficiency with Microsoft Windows Office tools
• Excellent interpersonal, organizational as well as verbal and written communication skills
• Must possess project management experience including managing multiple projects utilizing standard project management tools and best practices (e.g. MS Project and/or Smartsheet, Gantt project schedules, etc.)
• Familiarity with System Engineering tools (i.e. JAMA, etc...) a plus.
• LEAN/DFSS experience a plus.