Staff, Systems Engineer

Job Description

The System Systems Engineer leads and/or supports all Systems Engineering aspects on new product development efforts within the Olympus Surgical Technologies of America (OSTA) organization.  Their primary focus shall be NPD projects and the impacts that they have on the system deliverables. The major responsibilities of the position are performing and overseeing others perform activities such as defining system requirements, Sub-system requirements and software requirements and the associated specifications, making system architecture decisions, outlining design inputs, product design implementation, verification testing and supporting design validation studies. The ideal candidate is a hands-on technical leader with a strong systems design and integration background. (Knowledge of HW, SW and system integration) The Staff Systems Engineer is a subject matter expert (SME) and provides project and engineering leadership in all phases of complex med-device development, as well as ensures compliance to applicable Design Controls, Product Security, and Cybersecurity policies. (IEC62304, IEC81001-5-1, IEC62366, etc The individual shall serve as a core team member on PRP/NPD projects.

The Staff Systems Engineer is expected to drive design/concept trade-off decisions while taking costs, technical risk, reliability and User Needs into consideration. She / He must fully understand medical device design control requirements, have experience leading technical development efforts, and be effective at communicating advancements and issues to all levels of the organization.

Job Duties

• Provide project and technical leadership as it relates to Systems to cross functional teams including external partners for projects through conceptualization, development, product registration and commercialization.
• Establish and foster strong collaborative relationships with internal and external design/development partners, manufacturing partners and service providers.
• Provide critique and design guidance to ensure proper implementation and traceability of design outputs as compared to design inputs.
• Work closely with Marketing in collection of user needs/feedback on product requirements and concepts.
• Lead the requirements development and management process, incorporating risk management elements as required.
• Provide leadership on detailed design, requirements, architecture and data analysis.
• Experienced in developing User and Product Requirements.
• Experienced in planning Design Verification and Validation efforts to ensure the product effectively meets all requirements and applicable standards.
• Capable of effectively communicating with Core Team and Extended Team Members, while ensuring all R&D deliverables are completed with a high degree of quality, and attention to detail.
• Collaborates on the development of the technical development schedule and monitors Ensure compliance to product security and cyber security policies, and support efforts to author local SOP’s to ensure compliance. (IEC81001-5-1, IEC62304).
• Support the optimization of design control elements to comply with medical device regulations.
• Implement product design with the intention of optimizing design for manufacturability and testability.
• Consider Cost of Goods and lifecycle when selecting components for device designs.
• Develop engineering solutions, investigate competing technologies while considering the patent landscape, and protect engineering solutions by filing timely invention disclosures and working closely with the IP Legal team as needed.
• Establish and maintain detailed project plans, define risks and recommend contingency plans as required.
• Provide support of Risk Management activities, working with Design Assurance.
• Lead all technical project execution activities and oversee the development of statistically sound design verification protocols/reports, design validation, and delivery system qualification activities.
• Lead the system safety certification process to standards such as EN60601-1, EN60601-1-2.  Ensure software is developed in compliance to the methodologies of EN 62304.
• Provide technical support to Marketing for technical brochures, training programs, and technical presentations to customers and the sales force.
• Maintain knowledge of technical product landscape, competitive products and procedural trends for target procedural areas.
• Experienced in providing technical updates to systems leadership, and/or to an R&D Core Team Member, through weekly discussions and monthly updates.
• Capable of prioritizing and organizing work/efforts based on project priorities.
• Experienced in supporting robust design analysis, such as tolerance stack-ups, edge of failure testing, high/low specification evaluations, risk analysis, and statistical evaluations as necessary to ensure performance and quality.
• Proactively ideates and leads technical risk reduction activities and contingency planning.
• Consults with the Marketing core team member and clinicians to ensure a thorough understanding of the procedure, products use, and environmental factors to ensure appropriate design decisions.
• Manages, directs, and supports suppliers involved in product development and ongoing production, including external design and development partners.

Job Qualifications

Required:

• Bachelor’s degree in Mechanical Engineering or similar.
• Minimum years of related experience: 9+ years or 8+ years with MS or 5+ with PhD.
• Competency in leading medical device technical development efforts, through all phases of product development, is required.
• Experience developing products through a Phase Gate process as a Core Team member is highly preferred.
• Experience developing disposable medical devices required.
• Experience and or working knowledge of developing capital equipment is desired.
• Extensive working knowledge of, and experience in applying / developing products in compliance with FDA and international requirements, including 820-CFR, ISO-13485, IEC60601, QSR, etc. is required.  
• Proficient in Microsoft Windows Office applications including MS Outlook, MS Powerpoint, MS Project, Visio, etc.

Preferred:

• Self-motivated, engaged, and productive.
• Proficient in the creation and critical review of engineering drawings, including the ability to critique dimensioning and tolerancing strategies, is required.
• Working knowledge of Solidworks is a plus.
• Knowledge of common manufacturing methods, such as; injection molding and molded part design, extrusion, adhesives, ultrasonic welding, etc., as well as experience designing/developing products employing common medical device polymers is required.
• Must be able to solve complex and/or ambiguous problems using good judgement as well as logical and systematic thinking.
• Capable of providing problem solving guidance to other engineers.
• Must be able to use good judgement in making timely decisions.
• Able to balance risk vs. benefits in a variety of situations. 
• Must be able to envision design failure modes, plan for robust design assurance testing, and proactively implement contingency plans as necessary.
• Experience in the practical application of statistics and working knowledge of a statistical analysis package (Minitab is preferred).
• Must be able to collaborate effectively with others, work well within cross-functional teams and across multiple sites, as applicable.
• Must be able to drive for results.
• Must be able to communicate effectively at all levels, both verbally and in writing. Strong presentation skills and the ability influence.
• Able to predict and manage the expectations of project stakeholders.
• Inspires and motivates others and provides work direction.