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Olympus Corporation · 4 days ago

Principal Engineer, Design Quality - Software

Greater Boston

Full-time

Hybrid

Senior Level, Lead/Staff

$120K/yr - $168K/yr

8+ years exp

Olympus Corporation is a global medical technology company focused on improving lives through innovative solutions. The Principal Engineer, Design Quality - Software will provide professional expertise in software quality and best practices across the organization, ensuring compliance with regulatory standards for medical device software development.

ElectronicsIndustrialManufacturingMedical DeviceProduct Design

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

Medical device software standardsSoftware development processesProject managementML/AI applicationRegulatory Authority interactionEnglish proficiencyGerman languageJapanese languageTeamworkCommunication skillsOrganizational skillsTime management

Required

Undergraduate (BS) Degree in engineering, computer science, life sciences, or other related degree field

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

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

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