Massachusetts Jobs

Working Location: Massachusetts, Boston

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 Senior Design Quality Engineer provides professional expertise for Software quality and best practices in SW development 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 and drive the harmonization of the Software Development LifeCycle (SDLC) processes for all Olympus SW development entities. The Senior Design Quality Engineer serves as a subject matter expert for the application of medical device SW regulatory standards to the Olympus SDLC, including IEC 62304, IEC 82304, ISO 14971, ISO 81001-2, and AAMI TIR34971/CR34971. 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 and EU-MDR.

Job Duties

• Advise SW development teams on Software development processes and practices.

• Working with global cross functional teams, explore 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.

• Perform capability audits of software projects.

• Establish and monitor performance metrics for SW development activities.

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

• Minimum of 8 years of experience in the field of software development, software testing, or systems engineering, or 6 years for advanced degree. Minimum of 5 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

• 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:

• Experience in interacting with Regulatory Authorities is preferred.

• 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.

#LI-Hybrid

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.

Olympus requires all US new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.

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) || Boston ||