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Sr. Engineer
Location:
Center Valley, PA
Description:
Working Location:MASSACHUSETTS, WESTBOROUGH Workplace Flexibility:Hybrid Are you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together. Olympus, a leading medical technology company, has focused on making people's lives better for over 100 years. Our Purpose is to make people's lives healthier, safer, and more fulfilling. Our Core Values are reflected in all we do: Integrity : Empathy : Agility : Unity : Long:Term View We deliver on our purpose and our core values by staying True to Life. Job Description The Sr. R and D Engineer is responsible for assisting and/or leading the development of medical devicesemployed in various types of endoscopic surgeries. The primary responsibilities of this role includesupporting all phases of device development, in particular the identification and evaluation of designoptions, the definition of product / performance specifications, and design verification and validationactivities. Within a collaborative team environment, it will be expected that he or she will be a proactivecommunicator, collaborate well with others, manage their work efficiently, produce high quality work andconsistently seek additional knowledge and skills. Creation of technical data, data analysis, andsubsequent reporting will be an important aspect of this role, as well as helping to generate alldocuments / deliverables that will comprise the Design History File; therefore a working knowledge ofFDA Design Controls is required. May provide leadership and direction to Engineering Technicians. Job Duties: Provides technical leadership, and/or significant contributions, to product development projects and/or technology development efforts.: Contributes to all aspects of product development activities and product Design History Files, such as; requirements creation/documentation, ideation / prototyping, design / development documentation, technical risk mitigation, verification testing and reports, design validation studies, risk management documentation, design reviews, and supports the compilation of documents to enable regulatory submissions.: Develops engineering solutions, investigates competing technologies, and collaborates with Olympus Patent Attorneys to secure a strong IP portfolio as needed.: Supports or leads efforts to evaluate and identify design solutions which will meet product/performance requirements, cost targets, and manufacturability requirements.: Develops product verification and validation testing requirements, authors testing protocols and reports to ensure products meet and/or exceed established specifications.: Employs statistical techniques to establish exceptional product quality, reliability, and robustness.: Supports in ensuring product and performance specifications are appropriate and accurate.: Supports internal and external suppliers and manufacturers as needed.: Including external design and/or development partners.: Supports marketing in the planning and creation of technical brochures, training programs, and technical presentations to customers and the sales force.: Supports engineering leadership as required. : All additional duties as directed. Job Qualifications Required: : Bachelor's degree in engineering required.: Minimum 5years of related experience with MS or 2 years with PhD. Preferred: : Experience in Medical Device development and/or sustaining engineering efforts utilizing a stage:gate process. : Experience in hand held electro:mechanical devices is preferred.: Working knowledge of, and experience in applying, FDA Design Controls and international standards (e.g., Design Controls, 820:CFR, ISO14971, ISO10993, IEC60601, GMP, etc.).: Capable of developing many of the deliverables required to document the product design with appropriate specificity to enable hig
Posted:
June 29 on Tip Top Job
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More About this Listing: Sr. Engineer
Sr. Engineer is a Engineering Engineer Job located in Center Valley PA. Find other listings like Sr. Engineer by searching Oodle for Engineering Engineer Jobs.
Sr. Engineer is a Engineering Engineer Job located in Center Valley PA. Find other listings like Sr. Engineer by searching Oodle for Engineering Engineer Jobs.