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 R&D Systems Engineer will lead or support Systems Engineering aspects on new product development efforts within the Olympus Surgical Technologies of America (OSTA) organization. The ideal candidate will be a hands-on project and multi-disciplinary technical leader with a strong systems design and integration background. The candidate will be looked upon as a subject matter expert (SME), and will provide project and engineering leadership in all phases of device development, as well as ensure compliance to applicable Design Controls, Product Security, and Cybersecurity policies. Areas of focus will include identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, product security, cybersecurity, and equipment development oversight.

　　Extensive knowledge of medical device design control requirements, system design, software, hardware, digital image processing, integration testing, and design for manufacturability and testability is required. Deep understanding of medical device standards, and experience in their application, is required. This position is expected to provide leadership/mentorship to cross functional teams, and less experienced engineers/technicians.

　　Job Duties

　　Provide project and technical leadership to cross functional teams including external partners for projects through conceptualization, development, product registration and commercialization.

　　Establish and foster strong collaborative relationships with internal and external design/development partners, manufacturing partners and service providers. Provide critique and design guidance to ensure proper implementation and traceability of design outputs as compared to design inputs.

　　Work closely with Marketing in collection of user needs/feedback on product requirements and concepts.

　　Lead the requirements development and management process, incorporating risk management elements as required.

　　Ensure compliance to product security and cyber security policies, and support efforts to author local SOP’s to ensure compliance.

　　Support the optimization of design control elements to comply with medical device regulations.

　　Implement product design with the intention of optimizing design for manufacturability and testability.

　　Consider Cost of Goods and lifecycle when selecting components for device designs.

　　Develop engineering solutions, investigate competing technologies while considering the patent landscape, and protect engineering solutions by filing timely invention disclosures and working closely with the IP Legal team as needed.

　　Establish and maintain detailed project plans, define risks and recommend contingency plans as required.

　　Provide support of Risk Management activities, working with Design Assurance.

　　Lead all technical project execution activities and oversee the development of statistically sound design verification protocols/reports, design validation, and delivery system qualification activities.

　　Lead the system safety certification process to standards such as EN60601-1, EN60601-1-2. Ensure software is developed in compliance to the methodologies of EN 62304.

　　Provide technical support to Marketing for technical brochures, training programs, and technical presentations to customers and the sales force.

　　Maintain knowledge of technical product landscape, competitive products and procedural trends for target procedural areas.

　　Job Qualification

　　REQUIRED:

　　Bachelor’s degree in engineering or the equivalent in years of industry experience.

　　Minimum years of related experience: 9 years with a bachelor's degree or 8 years with master's degree or MBA or 5 with PhD.

　　PREFERRED:

　　Expertise in FDA Design Controls and systems development of medical devices.

　　Experience in statistical analysis package (Stat Ease, Minitab) preferred.

　　Proficient with the creation and critical review of engineering drawing and specification documentation.

　　Proficient in requirements management.

　　Must have extensive working knowledge and application of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as they relate to the design and manufacture of medical devices.

　　Experience with optics, digital image capture & processing is desirable.

　　Working knowledge of software lifecycle management in compliance to EN62304. Ability to evaluate software and software documents and provide effective feedback to development partners.

　　Proficient in Microsoft Windows environment including Outlook, Excel, Word and Project.

　　Must be able to solve complex problems and provide guidance to other engineers.

　　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