Sr. Principal Engineer - R&D

Job Description

The Senior Principal R&D Engineer is responsible for all aspects of product development from early innovation through commercialization. The major responsibilities of the position are both performing and overseeing others perform activities such as translating business strategies into product roadmaps and concepts, defining product specifications, design inputs, product design, verification testing and design validation studies. Evaluate alternatives including cost and risk, supportability and analyses for total device. He or she will partner with other cross-functional leaders to develop and influence strategies to grow the Business Unit and Divisional pipeline. He or she must fully understand medical device design control requirements and be able to effectively manage a product development project and work effectively in a cross functional team.  May serve as a core or extended team member for any stage of the product development lifecycle. Conducts feasibility studies of the design to determine ability to function as intended. Maintains detailed documentation throughout all phases of research and development. 

May provide leadership and direction to Engineering Technicians and mentor less experienced engineers within and across Olympus 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, Innovation and TDP Projects Represents Olympus and presents technical data at industry trade shows.
• Extensive technical expertise from concept through production.
• Owns all aspects of product development activities, such as prototyping, verification testing, design validation studies; risk documentation, design reviews, and documentation compilation for regulatory requirements.
• 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.
• Builds relationships with Sales, Marketing, and clinicians to facilitate new concepts and proper design of new or modified products.
• Manages, directs and supports vendors involved in product development and ongoing production.
• Provides technical expertise cross-functionally on technical brochures, training programs, and technical presentations to customers and the sales force.
• Conducts testing and collects the necessary product data to support the Value Analysis Committee Materials, Designs and various other 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.
• 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 14+ years of experience or 10+ with MS or 8+ with PhD.

Preferred:

• Proven results using the BioDesign Methodology and similar Innovation Frameworks.
• Experience in developing Innovation pitches focusing on technical and business merits.
• 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.