Senior Principal System Engineer, Biodevices

Role DescriptionPOSITION SUMMARY The Sr. Principal System Engineer (Sr. Pr. SE) will work as a key member of the research and development team in the design, development, testing and integration of electro-mechanical biodevice products. This position requires a highly creative and seasoned leader with a proven track record in creating new product concepts, a strong ability to transform concepts into realizable product architectures, expertise in developing system level requirements and experience in partitioning overall system requirements into specific components with well-defined interfaces. The Sr. Pr. SE will apply best practice development strategies with advanced technical problem solving techniques and have a history of working with cross-functional teams to resolve system-level issues throughout the product development life cycle. This role will provide technical leadership and influence on the design efforts of other engineers and developers and will drive the development team to create optimal products while adhering to committed project plans. The Sr. Pr. SE will also work cross-functionally with internal and external teams to define and ensure customer and product requirements are met while scaling the product for a successful market launch. POSITION RESPONSIBILITIES The Sr. Pr. SE has a wide and far-reaching variety of responsibilities, including:Drive requirements definition activities for new development. Lead efforts across a matrix organization to capture and clarify requirements and to resolve discrepancies when conflicting requirements are presented. Work with the commercial teams to translate high level customer requirements into implementable/testable product requirements.Facilitate concept and technology development strategies for new biodevice products including establishing proof-of-concept feasibility goals and protecting associated intellectual property.Act as lead architect and systems engineer in identifying product subsystems, interfaces, and overall systems operation. Ensure that early design considerations strive to optimize future-proofing of the product, accounting for both new features and obsolescence issues.Conduct trade studies to compare/contrast alternative system architectures. Analyze various alternatives against key requirements and make recommendations for product design based on risk and reward.Champion and facilitate the application of the stage-gate development process for new product development and create system level deliverables in accordance with the process.Provide technical guidance to design teams to ensure robust and reliable designs with seamless integration of electrical, mechanical, and software subsystems.Ensure designs meet or exceed product specifications, regulatory requirements, and international standards.Communicate complex technical situations in an understandable way to all organization levels.Coordinate problem solving of design issues.Function as technical liaison to suppliers and key stakeholders.Work with project teams to identify and mitigate development risks. EDUCATION AND EXPERIENCE B.S. in Mechanical, Systems or Electrical Engineering (or equivalent), MSME or MSEE preferred. Minimum of 20 years demonstrated engineering experience in a complex engineered product environment.Strong mechanical and electrical engineering knowledge and skills with 10 years in a lead system engineering role. Previous experience with automated biodevice equipment is highly desired. TECHNICAL SKILLS REQUIREMENTSExperience with advanced automated systems, preferably involving biological applications with optical, electrical, mechanical, software, pneumatic and fluid sub-systems. Broad engineering knowledge with extensive new product introduction, quality management system, manufacturing operations, and product lifecycle understanding.Experience and application of systems engineering processes and tools, e.g. JAMA, DOORS, SysML, etc.Knowledge of materials/processes/construction principles/machine shop practices.Knowledge of electro-mechanical system design, modeling, simulation and analysisKnowledge of software development lifecycle (SDLC) best practicesKnowledge of software/hardware integration in electromechanical automated systems.Excellent experience in design history file documentation, requirements documentation, and technical writing.Knowledgeable in 3D printing, rapid prototyping, and modern engineering techniques for development.Familiar with the application of control system theory, reliability analysis, root cause analysis techniquesDemonstrated proficiency in creating engineering specifications and technical requirements.Demonstrated experience in critical thinking and problem-solving skills, planning and organizing, decision-making.Knowledge in techniques such as Design for Six Sigma (DFSS), Design for Reliability(DFR), Design for Manufacturability and Assembly (DFMA), and Design for Serviceability (DFS)Excellent communication skills, influencing and leading, facilitation and teamwork capabilities.Prior experience in a regulated industry such as healthcare, medical devices, or pharmaceutical companies desirable.Team player who can challenge the team to think out of the box.Flexible and Adaptive; able to explore many ideas simultaneously.