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 Principal Engineer is responsible for performing and/or leading all aspects of product development, including technical planning and development strategy development, development of design inputs, and directing/supporting verification and validation efforts. In particular, it will be the responsibility of the Principal Engineer to ensure well defined product and performance specifications for the system are defined and tested to ensure all efforts are completed on schedule, while proactively mitigating potential issues, to enable the timely launch of high quality / reliable products. He or she must fully understand medical device design control requirements and be able to provide effective technical leadership to product development efforts and team members, negotiate strategies with cross-functional leaders, and work collaboratively across the organization. The Principal Engineer will serve as a core or extended team member on development projects. As the Principal Engineer will heavily contribute to Design History Files, maintaining detailed documentation throughout all phases of research and development is essential.

　　The Principal Engineer will provide leadership and direction to Engineering Technicians and mentor less experienced engineers within, and across, OSTA sites in best practices for the use of engineering tools and methods as needed.

　　Job Duties

　　Provides technical leadership on product development projects and/or technology development efforts.

　　Accountable for all aspects of product development activities and product Design History File, such as; requirements creation/documentation, ideation / prototyping, design / development, 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

　　Ideates, evaluates, and directs team towards design solutions which will meet product/performance requirements, cost targets, and manufacturability requirements.

　　Accountable for the development of effective/efficient product verification and validation testing strategies, testing protocols and reports, and ensures products meets/exceed established specifications.

　　Employs statistical techniques to establish exceptional product quality, reliability, and robustness.

　　Consults with the Sales, Marketing, and clinicians to define and specify product user requirements and ensures product and performance specifications are appropriate and accurate.

　　Manages, directs and supports internal and external suppliers and manufacturers as needed. Including external design and/or development partners.

　　Helps prepare and supports marketing on, technical brochures, training programs, and technical presentations to customers and the sales force.

　　Supports engineering leadership as required.

　　All additional duties as directed.

　　Job Qualification

　　Required:

　　Bachelor’s degree in engineering required.

　　Minimum years of related experience: 9+ years or 8+ years with MS or 5+ with PhD

　　Preferred:

　　Established track record of leading Medical Device development and/or sustaining engineering efforts utilizing a stage-gate process.

　　Experience / Knowledge of single use scope systems and technologies highly 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 development and manufacture of medical devices.

　　Capable of developing all 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.

　　Ability to communicate complex technical concepts clearly and concisely is required.

　　Ability to effectively work within a requirements management system (e.g., JAMA, Doors) preferred.

　　Experience in the practical application of statistics and working knowledge of a statistical analysis package (Minitab).

　　Must be able to collaborate effectively with others, work well within cross-functional teams and across multiple sites, as applicable.

　　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 .

　　The anticipated base pay range for this full-time position working at this location is $115,026.00 - $161,036.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.

　　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