Principal Design Assurance Engineer
Website Olympus Corporation of the Americas
In order to be considered, applicants must apply at our website at: https://career4.successfactors.com/sfcareer/jobreqcareer?jobId=1992&company=olympuscorP
The Principal Design Assurance Engineer is responsible for contributing to the design, development and management of projects for legacy products and support of new products under development. The Principal Design Assurance Engineer provides organizational support with a focus on Design Quality activities. Supports internal/external manufacturers providing finished products, services, components, and sub-assemblies to ensure compliance with company policies and procedures and medical device regulations. The Principal Design Assurance Engineer will partner with Operations, R&D, Supply Chain, Regulatory and other departments to continuously improve products and processes that meet all internal and external requirements and regulations.
* Assist in the design & execution of Product Development Process (PDP) for all OSTA design or distributed products.
* Lead and implement complex projects including quality improvement initiatives.
* Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.).
* Demonstrate project management skills and interact and collaborate with cross-functional teams.
* Proficient knowledge of risk assessment tools (e.g., ISO 14971, FMEA’s, FTA, I.S EN 62366).
* Proficient knowledge of Test Method Validations (TMV)
* In-depth knowledge of Post Market Surveillance.
* Proficient knowledge of Quality Engineering principles and methodologies.
* Proficient knowledge of Design Controls, CAPA, NC, etc.
* Provide leadership in understanding of the regulations to other disciplines within and outside the organization.
* Support and lead product Design Control activities for new product development efforts.
* Support and/or lead Process/Design Validation/Verification activities and approach including software validation.
* Assist in implementing cost of quality concepts, including cost of quality, data collection, & reporting.
* Support Manufacturing Engineering in the creation of DMR, DHR, routes, and bills of material, print changes, and specifications for in-house / external manufacturing.
* Communicate effectively at all levels within Quality as well as cross functionally with departments such as PD, Regulatory, Sales, Supply Chain, Regulatory, and Marketing in order to provide quality input.
* Perform other related duties as assigned by management.
* Bachelor’s Degree in Engineering required.
* Minimum of 10 years of experience in process quality engineering with an emphasis on Design Quality and Risk Management within an FDA regulated medical device manufacturing environment.
* Strong written and oral communication skills are required.
* Proficient with DMAIC / Black Belt / Six Sigma type tools to analyse, drive root cause, and solve problems.
* In-depth knowledge of statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab.
* In-depth of the design, development, and tolerancing of complex systems.
* Proficient knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR’s, ISO 13485, ISO 14971, I.S EN 62366, & ISO 11135.
* Must be self-motivated with a strong sense of urgency.
* Proficient in most common PC based applications (Word, Excel, PowerPoint, Project, & Visio), including Agile PLM.
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