Sr Principal R&D Engineer

Job Description

The Sr Principal R&D Engineer is responsible for contributing to the development and implementation of a strong technology and product pipeline strategy supporting Olympus’ Urology Business Unit. He or she will partner with cross-functional leaders to activate and drive target opportunities forward with the goal being to exceed customer and business needs. The major responsibilities of the position include guiding and overseeing product innovation activities (organic and inorganic), translating business strategies into product concepts, defining strategies for product specifications and design inputs, conceptual product design, and development/validation of preliminary business cases. The ideal candidate has the experience and ability to evaluate trade-offs such as cost, time and risk to make solid decisions with long-term impact. He or she must fully understand medical device design control requirements and be able to effectively guide a product development project and work effectively in a cross functional team.  Must have the experience and ability to serve as a core team member at any stage of the product development lifecycle and communicate a vision across the broad organization.

May provide leadership and direction to Engineering Technicians and mentor less experienced engineers within and across sites in best practices for the use of engineering tools and methods.

Job Duties

• Providing expertise and guidance to Olympus Engineers, Marketing, Manufacturing, and Management Project leader on Exploratory, Discovery, TRP and TDP Projects.
• Extensive technical expertise from concept through production.
• Develops engineering solutions, investigate competing technologies, research the patent landscape, and protect engineering solutions by filing invention disclosures.
• Responsible for the design and development of new products.
• Responsible for planning, scheduling, and executing all assigned projects.
• Consults with the Sales, Marketing, and clinicians to facilitate proper design of new or modified products.
• Manages, directs and supports vendors involved in product development and ongoing production.
• Prepares and acts as a consultant to marketing on technical brochures, training programs, and technical presentations to customers and the sales force.
• Conducts testing and collects the necessary product dat a to support the Value Analysis Committee Materials Designs various aspects of medical devices with a focus on design for manufacturability, ergonomics and COGS.
• Works directly with Marketing to define and specify new product user requirements, design inputs for medical devices.
• Develops product verification and validation testing requirements, testing protocols and testing reports to ensure products meet specification.
• Acts as a consultant, as needed, to other departments, customers, and upstream marketing.
• Investigates and solve critical production product/process problems on demand.
• Perform design analysis, e.g. tolerance stack-ups, strength of materials (factor of safety), FEA risk analysis, etc. required for new and existing products.
• Working knowledge of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as they relate to the design and manufacture of medical devices.
• All Other Essential Duties as directed.

Job Qualifications

Required:

• Bachelor’s degree in Engineering or the equivalent in years of industry experience.
• Minimum years of related experience: 14+ years or 10+ with MS or 8+ with PhD.

Preferred:

• Experience in statistical analysis package (Stat Ease, Minitab), preferred.
• Proficient with the creation and critical review of engineering drawing and specification documentation.
• Proficient in Geometric dimensioning and tolerance.
• Must have working knowledge of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as they relate to the design and manufacture of medical devices.
• Proficient in Microsoft Windows environment, Outlook, excel, MS project, 3D CAD/CAM software
• Must be able to solve complex problems and provide guidance to other engineers.
• Must be able to work with ambiguity and uses good judgement in making decisions. Able to balance risk and opportunities.
• Must be able to collaborate effectively with all levels, works well within cross-functional teams and across multiple sites, as applicable.
• Must be able to manage resources and drives for results, effectively managing projects and timelines.
• Must be able to communicate effectively at all levels, both verbally and in writing. Has strong presentations skills and the ability to influence.
• Inspires and motivates others and may provide work direction.