Principal Engineer Design Quality - Software

Working Location: MASSACHUSETTS, WESTBOROUGH; Nationwide 

Workplace Flexibility: Hybrid

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

 

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is 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, 81001-5-1, 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 (SiMD/SaMD/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 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 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 influen