Senior Principal System Engineer

Senior Principal System Engineer

Requirements

• 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
• Experience 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 analysis
• Knowledge of software development lifecycle (SDLC) best practices
• Knowledge 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 techniques
• Demonstrated 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 Servicability (DFS)
• Excellent communication skills, influencing and leading, facilitation and teamwork capabilities

Responsibilities

• 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

Preferred Qualifications

• Previous experience with automated biodevice equipment is highly desired
• 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