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R&D Engineer II
2 months ago
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 related experience: 2 years with BS or 0 years with MS. Experience in statistics required, working knowledge of a statistical analysis package (Minitab) a plus. 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.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. Why join Olympus? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Equitable Offerings you can count on:Competitive salaries, annual bonus and 401(k)* with company match
Comprehensive medical, dental, vision coverage effective on start date
24/7 Employee Assistance Program
Free live and on-demand Wellbeing Programs
Generous Paid Vacation and Sick Time
Paid Parental Leave and Adoption Assistance*
12 Paid Holidays
On-Site Child Daycare, Café, Fitness Center**
Connected Culture you can embrace:Work-life integrated culture that supports an employee centric mindset
Offers onsite, hybrid and field work environments
Paid volunteering and charitable donation/match programs
Diversity Equity & Inclusion Initiatives including Employee Resource Groups
Dedicated Training Resources and Learning & Development Programs
Paid Educational Assistance
*US Only **Center Valley, PA and Westborough, MA Are you ready to be a part of our team? . At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. 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, 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. Applicants with Disabilities: Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Research and Development