Principal Engineer, Design Quality - Software Job Details | Olympus Corporation of the Americas
Olympus
Optoelectronic Equipment
Westborough, MA - USA
Senior Specialist / Project Manager
Experteer Overview
In this role you will provide expert guidance on software quality and regulatory best practices across the global SDLC, ensuring compliant design, development, and release of health software. You will collaborate with product, engineering, and regulatory teams to align on feasible requirements and support submissions to regulatory authorities. You’ll lead updates to SDLC processes to incorporate ML/AI, cloud, and security/privacy considerations, while overseeing QMS activities and audits. This role is pivotal for delivering safe, effective medical software at Olympus.
Compensation / Benefits
- Competitive salaries
- Annual bonus
- 401(k) with company match
- Comprehensive medical, dental, vision coverage
- Paid parental leave
- 12 paid holidays
Responsibilities
- Advise development teams on software processes, architecture, and regulatory impact (SiMD/SaMD/Health SW/Cloud)
- Harmonize SW processes across Olympus entities
- Serve as SME on health software regulations for medical devices
- Update SDLC/operations for ML/AI, cloud, security-by-design, privacy-by-design
- Guide Agile practices to balance rapid delivery with compliance and quality
- Provide project management oversight for QMS integration, quality plans, and training
- Represent SW development QMS during inspections and audits
- Establish and monitor performance metrics for SW development activities
- Support response framework for SDLC audit findings and regulatory queries
- Communicate significant issues to senior management with containment actions
- Support post-market surveillance including complaint metrics and CAPA for software activities
Key requirements
- BS in engineering, computer science, life sciences, or related field; MS/PhD preferred
- Minimum 9 years in software development, testing, or systems engineering (8+ years for advanced degree)
- Minimum 6 years in a medical device setting
- Experience applying standards to medical device software and health software (SaaS)
- Experience in project management; Regulatory Authorities interaction preferred
- Working knowledge of ML/AI in Health SW and medical devices
- Experience cross-border collaboration across national/cultural boundaries
- Proven ability to lead and train a multinational, cross-functional team
- Strong verbal/written English; German/Japanese a plus
- Willingness to travel up to 15% and work across time zones
Description
In this role you will provide expert guidance on software quality and regulatory best practices across the global SDLC, ensuring compliant d…
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