Location: Westborough, MA
Company: Olympus
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 R&D Engineer II is responsible for assisting in the development of medical devices for use 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 Contributes 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 meet product/performance requirements, cost targets, and manufacturability requirements. Authors product verification testing protocols and reports and ensures products meet/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 engineering leadership as required. All additional duties as directed. Job Qualifications Required: Bachelor’s degree in engineering (Biomedical or equivalent preferred). Minimum years of 2+ years of experience or 0+ years with MS.
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 FDA Design Controls required, working knowledge of international standards (e. g. ISO14971, ISO10993, IEC60601, etc. ) a plus. Experience developing product design deliverables a plus. Proficient in Microsoft Windows Office applications including MS Outlook, MS Powerpoint, MS Project, Visio, etc. Solidworks working knowledge a plus. Knowledge of common manufacturing methodologies, technologies, and materials employed in medical devices preferred.
Able to solve complicated technical challenges and use good judgement in making timely decisions. Experience in statistics required, working knowledge of a statistical analysis package (Minitab) a plus. Why join Olympus? Here, people matter—our health, our happiness, and our lives. Competitive salaries, annual bonus and 401(k) with company match Comprehensive Medical, Dental, Visions coverage effective on start date 24/7 Employee Assistance Program Free virtual live and on-demand wellness classes Work-life balance supportive culture with hybrid and remote roles 12 Paid Holidays Educational Assistance Parental Leave and Adoption Assistance Volunteering and charitable donation match programs Diversity & Inclusion Programs including Colleague Affinity Networks On-Site Child Daycare, Café, Fitness Center US Only Limited locations We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you.
Learn more about our benefit offerings at /careers/benefits-perks. About us: Our 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 costs, and enhance the quality of life for patients and their safety.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America.
For more information, visit . Olympus is dedicated to building a diverse, inclusive and authentic workplace We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive. Let’s realize your potential, together. 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, interaction (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, interactionual 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 Research and Development
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