Principal Engineer, Design Quality - Software

Working

Location:

Nationwide
Workplace Flexibility:
Remote

This role provides professional expertise for software quality and best practices in SW design, development, release, and support across the global organization. The position supports development teams in applying regulatory rigor to Agile software development practices and provides subject‑matter expertise, technical guidance, and leadership for applying health and medical device software regulatory standards to the Olympus SDLC, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, ISO 81001‑2, ISO 81001‑5‑1, and AAMI TIR
34971.

• Advise SW development teams on software development processes and practices (SiMD/SaMD/Health SW/Cloud) and on architecture regarding 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 updating the SDLC and operations processes to include ML/AI development, cloud infrastructure and validation best practices.
• Collaborate on updating the SDLC and operations processes to include 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.
• Communicate 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.

• Undergraduate (BS) degree in engineering, computer science, life sciences or other related field. An advanced degree such as an MS or PhD is preferred.
• Minimum of nine years of experience in software development, software testing or systems engineering, or minimum of eight years for advanced degree.
• Minimum of six 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 interacting with regulatory authorities is preferred.
• Working knowledge of ML/AI applied to health SW and medical devices.
• Experience working across national and cultural boundaries.
• Demonstrated capability to lead and train a large, diverse, multinational community with multiple stakeholders, coaching, mentoring and influencing capacity.
• Strong teamwork and communication skills to work effectively on cross‑functional project teams, interacting with disciplines such as R&D, Quality Engineering, Regulatory Affairs, etc.
• Independent organizational and time‑management skills are required.
• Strong verbal and written communication skills in English;
  German and/or Japanese is a plus.
• Will work with global teams; availability includes working across associated time zones; some flexibility in work hours is expected.
• Travel up to 15% of the time. Candidate can work from home on a regular basis.

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We embrace a non‑discriminatory, inclusive work environment where everyone feels a sense of belonging in full compliance with legal standards. Applicants requesting accommodations:
Olympus is committed to the full inclusion of qualified individuals. Persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact  or call 1‑888‑659‑6787. We extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin, citizenship status, religious creed, age, sex, gender, gender identity and expression, sexual orientation, marital status, disability or any characteristic protected by applicable law.