Working Location: MASSACHUSETTS, WESTBOROUGH

Workplace Flexibility: Hybrid

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​ ​

​

Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

​

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus (https://www.olympusamerica.com/careers) .

**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

Job Description

The Principal Design Quality Engineer provides professional expertise for Software quality and best practices in SW design, development, release, and support across the global organization and assists development teams in applying regulatory rigor to Agile SW development practices. This individual will lead Software Quality’s participation in and drive the harmonization of the Software Development Lifecycle (SDLC) processes for all Olympus SW development entities. The Principal Design Quality Engineer provides subject matter expertise, technical guidance, and leadership for the application of medical device SW regulatory standards to the Olympus SDLC, including IEC 62304, IEC 82304, ISO 14971, ISO 81001-2, 81001-5-1, and AAMI TIR34971. This includes providing leadership, technical direction and collaboration on development strategies, concepts, design evaluation and proof of concept. Must work with product management, business units, engineering product owners and software architects to define feasible product requirements. This individual will be responsible for review and approval of documentation deliverables from assigned projects as required by the SDLC and will support Regulatory Affairs’ efforts in creating submission materials for various regulatory domains including FDA, PMDA, and EU-MDR.

Job Duties

• Advise SW development teams on Software development processes and practices (SiMD/SaMD/Cloud) Advise SW development teams on architecture in the context of regulatory impact.

• Investigate and implement harmonization of SW processes across different Olympus legal entities. Advise Olympus as a Subject Matter expert on regulations around SW development for medical devices. Collaborate on the update of SDLC and operations processes and activities for the inclusion of ML/AI development and validation best practices.

• Collaborate on the update of SDLC and operations processes and activities for the inclusion of product security in SW development and validation.

• Represent Olympus’s SW development QMS during inspections and audits.

• Advise on, monitor, and review quality artefacts from SW projects.

• Perform capability audits of software projects.

• Establish and monitor performance metrics for SW development activities.

• Establish a framework for SW release management and monitoring thereof.

• Establishment of a response framework for queries and audit findings related to the SDLC. Communicates significant issues to senior management, including appropriate containment and correction activities, as applicable

Job Qualifications

Required:

• Undergraduate (BS) Degree in engineering, computer science, life sciences, or other related degree field.

• Minimum of 9 years of experience in the field of software development, software testing, or systems engineering, or minimum of 8 years for advanced degree. Minimum of 6 years of experience in a medical device setting.

• Experience in the application of relevant standards to medical device software development

• Experience in working across national and cultural boundaries.

• Demonstrated capability to lead and train a large and diverse, multinational community with multiple stakeholders, working in a collaborative, coaching, mentoring and/or influencing capacity.

• Strong teamwork and communication skills to work effectively on cross-functional project teams, Interacting with a diversity of disciplines such as R&D, Quality Engineering, Regulatory Affairs, etc.

• Independent organizational and time management skills is required.

• Strong verbal and written communication skills in English and Japanese.

• Will work with global teams; availability will include working across the associated time zones; some flexibility in work hours will be expected.

• Travel up to 15% of the time. Candidate will be able to work from home on a regular basis.

Preferred:

• An Advanced degree such as an MS or PhD is preferred.

• Experience in interacting with Regulatory Authorities is preferred.

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?

Learn more about our benefit and incentives (https://www.olympusamerica.com/careers/benefits-perks) .

The anticipated base pay range for this full-time position working at this location is $116,751.00 - $163,452.00 / 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.

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 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.

Applicants with Disabilities:

As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)