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 Senior R&D Engineer is responsible for assisting and/or leading the development of medical devices employed in various types of endoscopic procedures. 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 Design Controls, testing, and design for manufacturability are 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 year of related experience: 5 years or 4 years with MS or 0-2 years with PhD.

　　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 high volume manufacturing with high quality.

　　Proficient in Microsoft Windows Office applications including MS Outlook, MS Powerpoint, MS Project, Visio, etc..

　　Solidworks working knowledge. Proficient in the creation and critical review of engineering drawings, tolerancing 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).

　　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.

　　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.

　　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 https://www.olympusamerica.com/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 www.olympusamerica.com .

　　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, 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 || Research and Development