Principal Engineer, Design Quality - Software

Req ID: 10001

Working Location: MASSACHUSETTS, WESTBOROUGH; CALIFORNIA, SAN JOSE; COLORADO, GOLDEN; FLORIDA, MIAMI; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY; TENNESSEE, BARTLETT; WASHINGTON, REDMOND

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.

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 and drive the harmonization of the Software Development LifeCycle (SDLC) processes for all Olympus SW development entities, and the training activities that come with it. 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. The role comes with project management responsibilities, including management of vendors, QMS integration efforts, and SW design assurance training curriculum.

Job Duties

Advise SW development teams on Software development processes and practices (SiMD/SaMD/Cloud).
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.
Provide project management oversight for QMS integration, Quality plans, process updates, and training.
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.
Minimum of 9 years of experience in the field of software development, software testing, or systems engineering (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 project management.
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.
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.

Preferred:

An Advanced degree such as an MS or PhD is preferred.
Experience in interacting with Regulatory Authorities is preferred.
Strong verbal and written communication skills in English; German and/or Japanese is a plus.

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
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 benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.

The anticipated base pay range for this full-time position working at this location is $119,670.00 - $167,538.00 / 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.

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact 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).

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 || Quality & Regulatory Affairs (QA/RA)

Nearest Major Market: Worcester
Job Segment: Medical Device Engineer, Cloud, Quality Engineer, Testing, Design Engineer, Engineering, Technology

Apply now »