Job Description

The Principal R&D Systems Engineer leads and/or supports all Systems Engineering aspects on new product development efforts within the Digital Unit (DU) organization. The major responsibilities of the position are performing and overseeing others perform activities such as defining product requirements and 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 project and multi-disciplinary technical leader with a strong systems design and integration background. The Principal 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. The individual may serve as a core or extended team member on PRP/NPD projects.

Areas of focus also include Systems aspects of identification of user needs, risk assessments as well as product and cybersecurity.

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.

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 Product Managers 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.
• Maintain knowledge of technical product landscape, competitive products and procedural trends for target procedural areas.

Job Qualification

Required:

• Bachelor’s degree in electrical, Software or Systems Engineering.
• Minimum of 14 years' experience with a BS, or
• Minimum of 10 years' experience with MS or
• Minimum of 8 years' experience with PhD.

Preferred:

• Expertise in Developing complex medical systems that include hardware, software, systems and disposables/reusables.
• Expertise in FDA Design Controls and systems development of medical devices.
• 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.
• Must be able to work with ambiguity and use good judgement in making decisions. Able to balance risk and opportunities.
• Must be able to collaborate effectively with others, works well within cross-functional teams and across multiple sites, as applicable.
• Must be able to manage resources and drive for results, effectively managing projects and timelines.
• Must be able to communicate effectively at all levels, both verbally and in writing. Strong presentation skills and the ability influence.
• Inspires and motivates others and provides work direction.