Olympus Corporation of the Americas Principal R&D Engineer in Southborough, Massachusetts
Working Location: MASSACHUSETTS, SOUTHBOROUGH
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.
The Principal Engineer maintains responsibility for performing and/or leading all aspects of product development including technical planning, feasibility studies, device development, verification and validation. The primary responsibilities of the position are defining product specifications, design inputs, product design, verification testing and supporting design validation studies. Other activities include evaluating alternatives with consideration for cost, technical risk, reliability and User Needs. She / He must fully understand medical device design control requirements and be able to effectively manage a product development project and work effectively in a cross functional team. The incumbent may serve as a core or extended team member on development projects. Maintains detailed documentation throughout all phases of research and development.
Provide technical leadership on product development projects and/or technology development efforts.
Maintain accountability for all aspects of product development activities and associated deliverables such as: Design History File compilation, translation / creation and documenting of requirements, ideation / prototyping, technical risk mitigation, verification testing and reports, design validation studies, risk management documentation, design reviews, and to support the compilation of documentation to enable regulatory submissions.
Develop engineering solutions, investigate competing technologies, and collaborate with Olympus Patent Attorneys to secure a strong IP portfolio.
Direct or perform design analysis, such as tolerance stack-ups, strength of materials, risk analysis, and statistical evaluations.
Ensure product designs are cost effective, designed for manufacturability, and exhibit a high degree of quality and reliability via well thought out [and executed] verification test plans.
Consult with the Sales, Marketing, and clinicians to define and specify product user requirements.
Manage, direct, and support suppliers involved in product development and ongoing production. This includes outside design and/or development partners.
Help prepare, and acts as a consultant to, marketing on technical brochures, training programs, and technical presentations to customers and the sales force
Bachelor’s degree in Mechanical Engineering or equivalent required.
Minimum years of related experience: 9+ years or 8+ years with MS or 5+ with PhD.
Experience working with outside development partners from product concept through launch is preferred.
Knowledge of/experience with GYN and GI Endotherapy products/anatomy/procedures preferred.
Must have extensive working knowledge of, and experience in applying / developing products in compliance with FDA and international requirements, including 820-CFR, ISO14971, IEC60601, GMP and other standards as they relate to the design and manufacture of medical devices.
Proficient in Microsoft Windows Office applications including MS Outlook, MS Powerpoint, MS Project, Visio, etc..
Solidworks working knowledge is a plus. Proficient in the creation and critical review of engineering drawings including geometric dimensioning and tolerancing and tolerance analysis.
Knowledge of common manufacturing methodologies, technologies, and materials, such as; injection molded part design, common materials employed in medical devices, and other manufacturing processes.
Must be able to solve complex and/or ambiguous problems using good judgement as well as logical and systematic thinking.
*Capable of providing problem solving guidance to other engineers.
Ability to balance risk vs. benefits in a variety of situations.
Experience in the practical application of statistics and working knowledge of a statistical analysis package (Stat Ease, Minitab are preferred).
Must be able to collaborate effectively with others, work well within cross-functional teams and across multiple sites, as applicable.
Must be able to communicate effectively at all levels, both verbally and in writing.
Inspires and motivates others and provides work direction.
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 at https://www.olympus-global.com/ .
Olympus…True To You. True To Society. True To LIFE.
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) || Southborough ||