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Senior R&D Engineer

Company: Olympus Corporation of the Americas
Location: Westborough
Posted on: April 10, 2021

Job Description:

Working Location:--MASSACHUSETTS, WESTBOROUGH-- Are you looking for a company that cares about people's lives and health, including yours? At Olympus, we help make people's lives healthier, safer and more fulfilling, every day.--
--
Let's inspire healthier lives, together. Job Description The Senior R&D Engineer is responsible for assisting and/or leading the development of medical devices employed in various types of endoscopic surgeries. The primary responsibilities of this role include supporting all phases of device development, in particular the identification and evaluation of design options, the definition of product / performance specifications, and design verification and validation activities. Within a collaborative team environment, it will be expected that he or she will be a proactive communicator, collaborate well with others, manage their work efficiently, produce high quality work and consistently seek additional knowledge and skills. Creation of technical data, data analysis, and subsequent reporting will be an important aspect of this role, as well as helping to generate all documents / deliverables that will comprise the Design History File; therefore a working knowledge of FDA Design Controls is required. 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 and innovations, collaborates with Olympus IP Attorneys as needed.
-- * Supports or leads efforts to evaluate and identify design solutions which will meet product/performance requirements, cost targets, and manufacturability requirements.
-- * Develops verification and validation testing strategies, authors testing protocols and reports, and ensures products meet and/or exceed established specifications.
-- * Maintains an understanding of applicable industry guidance documents and testing standards and ensures appropriate consideration and compliance.
-- * Employs statistical techniques to establish exceptional product quality, reliability, and robustness.
-- * Supports in ensuring product and performance specifications are appropriate and accurate.
-- * Supports and/or directs internal and external design partners, suppliers and manufacturers as needed.
-- * Leads and/or supports testing to support marketing collateral, training programs, and launch activities.
-- * Provides regular updates to engineering and marketing leadership on product status and advancement.
-- * Supports engineering leadership as required.
-- * Perform all other duties as assigned.
-- Job Requirements REQUIRED QUALIFICATIONS: * Minimum year of related experience: 5+ years or 4+ years with MS or 0-2 years with PhD. PREFERRED QUALIFICATIONS:
* 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 leading & developing many of the Design Control deliverables required to document a product design and establish compliance with Design Inputs with appropriate specificity and quality. * Proficient in Microsoft Windows Office applications including MS Outlook, MS Powerpoint, MS Project, Visio, etc.. * Solidworks working knowledge and experience in developing efficient / manufacturable designs. Proficient in the creation and critical review of engineering drawings (appropriate tolerances) and tolerance analysis. * Knowledge of common manufacturing methodologies, technologies, and materials employed in medical devices. * Must be able to solve complicated technical challenges and use good judgement in making timely decisions.-- * Experience in the practical application of statistics and working knowledge of a statistical analysis package (Minitab). * Must be able to collaborate effectively with others, works well within cross-functional teams and across multiple sites, as applicable. * Must be capable to effectively executing on multiple work streams in parallel. * Must be able to communicate effectively, both verbally and in writing. Comfortable presenting information to team members and stakeholders. * Must be able to work in a professional open-space environment without distracting others. * Must have a positive attitude and capable of accomplishing efforts in a timely manner and with high quality. We realize work isn't just a job to you.

It's a big part of your life, but not the only part. That's why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks - so you can be ready for where life can take you. Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world. Olympus' Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus' Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com . It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. Posting Notes: -- United States (US) -- Massachusetts (US-MA) -- Westborough ----

Keywords: Olympus Corporation of the Americas, Worcester , Senior R&D Engineer, Engineering , Westborough, Massachusetts

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