Olympus Corporation · 1 week ago
Principal Engineer, Design Quality - Software
United States
Full-time
Remote
Lead/Staff
$120K/yr - $168K/yr
8+ years expOlympus Corporation is a global medical technology company focused on advancing medical technologies and elevating patient care. The Principal Engineer, Design Quality - Software role involves providing expertise in software quality and regulatory standards for medical devices, leading teams in Agile software development practices, and ensuring compliance across the organization.
ElectronicsIndustrialManufacturingMedical DeviceProduct Design
No H1B
Responsibilities
Advise SW development teams on Software development processes and practices (SiMD/SaMD/Health SW/Cloud). Advise SW development teams on architecture in the context of regulatory impact, safety, security and best practices
Investigate and implement harmonization of SW processes across different Olympus legal entities
Advise Olympus as a Subject Matter expert on regulations around health software development, and software for medical devices
Collaborate on the update of SDLC and operations processes and activities for the inclusion of ML/AI development, cloud infrastructure, and validation best practices
Collaborate on the update of SDLC and operations processes and activities for the inclusion of security-by-design and privacy-by-design in SW development
Collaborate with development teams on applying Agile development practices for continuous rapid product delivery while maintaining compliance and quality
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
Support post-market surveillance operations including complaint monitoring and metrics. NC, CAPA, HHA, and FCA for software related activities
Qualification
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 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 and non-medical device health software development, including Software-as-a-Service
Experience in project management
Experience in interacting with Regulatory Authorities is preferred
Working knowledge in the application of ML/AI to Health SW and medical devices
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; German and/or Japanese is a plus
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
German and/or Japanese is a plus
Benefits
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
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
Company
Olympus Corporation
Olympus is passionate about creating customer-driven solutions for the medical industry.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Nacho Abia
Chief Executive Officer (CEO) - Olympus Corporation of Americas
Bree Beauregard (she/her)
Sr HR Manager, Global HR Business Partner
Recent News
2025-05-27
2025-05-19
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