
Sr Principal R&D Engineer
- Westborough, MA
- $162,565-243,847 per year
- Permanent
- Full-time
- 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.
- 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.
- 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.