Principal Systems Engineer
Website Olympus Corporation of the Americas
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The Principal R&D Systems Engineer will lead or support Systems Engineering aspects on new product development efforts within the Olympus Surgical Technologies of America (OSTA) organization. The ideal candidate will be a hands-on project and multi-disciplinary technical leader with a strong systems design and integration background. The candidate will be looked upon as a subject matter expert (SME), and will provide project and engineering leadership in all phases of device development, as well as ensure compliance to applicable Design Controls, Product Security, and Cybersecurity policies. Areas of focus will include identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, product security, cybersecurity, and equipment development oversight.
Extensive knowledge of medical device design control requirements, system design, software, hardware, digital image processing, integration testing, and design for manufacturability and testability is required. Deep understanding of medical device standards, and experience in their application, is required. This position is expected to provide leadership/mentorship to cross functional teams, and less experienced engineers/technicians.
* Provide project and technical leadership 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.
* Ensure compliance to product security and cyber security policies, and support efforts to author local SOP’s to ensure compliance.
* 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.
* Bachelor’s degree in Engineering or the equivalent in years of industry experience.
* Minimum years of related experience: 9 years with a Bachelor’s degree or 8 years with Master’s degree or MBA or 5 with PhD.
* Expertise in FDA Design Controls and systems development of medical devices.
* Experience in statistical analysis package (Stat Ease, Minitab) preferred.
* Proficient with the creation and critical review of engineering drawing and specification documentation.
* Proficient in requirements management.
* Must have extensive working knowledge and application of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as they relate to the design and manufacture of medical devices.
* Experience with optics, digital image capture & processing is desirable.
* Working knowledge of software lifecycle management in compliance to EN62304. Ability to evaluate software and software documents and provide effective feedback to development partners.
* Proficient in Microsoft Windows environment including Outlook, Excel, Word and Project.
* Must be able to solve complex problems and provide guidance to other engineers.
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