Location: Westborough, MA
Company: Olympus
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 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, , 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 (Si MD/Sa MD/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.
An Advanced degree such as an MS or Ph D is preferred. 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. 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. Candidate will be able to work from home on a regular basis. Preferred: Experience in interacting with Regulatory Authorities is preferred. 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. Strong verbal and written communication skills in English and Japanese. #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 /careers/benefits-perks. The anticipated base pay range for this full-time position working at this location is $115,026.00 - $161,036.00 / 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. 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 . 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, interaction (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, interactionual 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
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