Principal Engineer, Design Quality - Software
About The Position
This role 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 position provides subject matter expertise, technical guidance, and leadership for the application of health and medical device SW regulatory standards to the Olympus SDLC, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, ISO 81001-2, ISO 81001-5-1, and AAMI TIR34971. This includes providing leadership, technical direction and collaboration on development strategies, concepts, design evaluation and proof of concept. This individual must work with product management, business units, engineering product owners and software architects to define feasible product requirements. This individual is 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.
Requirements
- 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.
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
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
