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Senior SUE R&D Engineer

Olympus Medical Systems

Olympus Medical Systems

This job is no longer accepting applications

See open jobs at Olympus Medical Systems.
Westborough, MA, USA
Posted on Friday, January 19, 2024

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 Staff R&D Engineer ia responsible for all aspects of product development acting as a individual contributor, or where applicable, as a Core Team Member. In this role, the Staff R&D Engineer will execute all aspects of product development for Olympus’s Westborough Development Center. In this dynamic role, the Staff R&D Engineer will have the ability to work on a variety of products, supporting multiple Business Units, with successful product launches over time and as project demands warrant. The Staff R&D Engineer will lead or contribute to efforts to define user and product requirements, collaborate with project managers and other Core Team Members on project execution strategy, timelines and costs, lead product design and prototyping efforts, execute product feasibility testing, technical risk reduction planning, design verification and validation testing strategy and testing efforts, lead or contribute to design analysis testing, and ultimately the generation of all design controls documentation in collaboration with external and/or internal development and manufacturing/quality partners. The Staff R&D Engineer is expected to drive design/concept trade-off decisions while taking costs, technical risk, reliability and User Needs into consideration. She / He must fully understand medical device design control requirements, have experience leading technical development efforts, and be effective at communicating advancements and issues to all levels of the organization.

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 Qualification

Required:

  • Bachelor’s degree in mechanical engineering or similar.
  • Minimum of 9 years of related experience or 8+ years with MS or 5+ with PhD.

Preferred:

  • Competency in leading medical device technical development efforts, through all phases of product development, is required.
  • Experience developing products through a Phase Gate process as a Core Team member is highly preferred.
  • Experience developing disposable medical devices required.
  • Experience and or working knowledge of developing capital equipment is desired.
  • Extensive working knowledge of, and experience in applying / developing products in compliance with FDA and international requirements, including 820-CFR, ISO-13485, IEC60601, QSR, etc. is required.
  • Proficient in Microsoft Windows Office applications including MS Outlook, MS Powerpoint, MS Project, Visio, etc.

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

This job is no longer accepting applications

See open jobs at Olympus Medical Systems.