Senior Engineer, Design Quality, Software

Working Location: Minnesota, Brooklyn ParkWorkplace Flexibility: HybridFor more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.Job DescriptionThe Senior Design Quality Engineer provides professional expertise for Software quality and best practices in SW development across the global organization and assists development teams in applying regulatory rigor to Agile SW development practices, including SW release and manufacturing. This individual will lead Software Quality's participation in specifying and monitoring software manufacturing and post‑market operations, serving as a subject‑matter expert for the application of medical device SW regulatory standards to the Olympus SDLC, and supporting Regulatory Affairs in creating submission materials for FDA, PMDA, and EU‑MDR.Anticipated base pay range for this full‑time position in this location is $95,904.00 – $129,470.00 per year, plus potential for annual bonus.Job DutiesAdvise software development and operations teams on software processes and practices including release, manufacturing, and post‑market operations.Explore and implement harmonization of software manufacturing and operations processes across different Olympus legal entities.Provide subject‑matter expertise on regulations around software manufacturing and cloud operations.Provide subject‑matter expertise on regulations around software post‑market monitoring for medical and health software products.Collaborate on the update of SDLC and operations processes and activities for manufacture, distribution, and operation monitoring of software.Collaborate on the update of SDLC and operations processes and activities for inclusion of product security in software operations environments.Represent Olympus's software manufacturing and post‑market operations QMS during inspections and audits.Perform capability audits of software projects.Establish and monitor performance metrics for software manufacturing and post‑market activities.Support the establishment of a dashboard for post‑market operations for software products.Communicate significant issues to senior management, including appropriate containment and correction activities, as applicable.Job QualificationsRequired:Undergraduate (BS) degree in engineering, computer science, life sciences, or related field.Minimum of 8 years of experience in software development, software testing, or systems engineering, or 6 years for advanced degree.Minimum of 5 years experience in a medical device setting.Experience applying relevant standards to medical device software manufacturing, release, and post‑market operations.Experience working across national and cultural boundaries.Demonstrated capability to lead and train a large, diverse multinational community with multiple stakeholders, working collaboratively and mentoring.Strong teamwork and communication skills for cross‑functional project teams, interacting with disciplines such as R&D, Quality Engineering, Regulatory Affairs, etc.Independent organizational and time‑management skills.Strong verbal and written communication skills in English.Availability for global teams, including working across associated time zones; some flexibility in work hours expected. Travel up to 15% of the time. Ability to work from home on a regular basis.Preferred:Advanced degree such as an MS or PhD.Experience interacting with regulatory authorities.Optional Japanese communication skill as an added plus factor.Equitable Offerings you can count onCompetitive salaries, annual bonus and 401(k) with company matchComprehensive medical, dental, vision coverage effective on start date24/7 Employee Assistance ProgramFree live and on-demand wellbeing programsGenerous paid vacation and sick timePaid parental leave and adoption assistance12 paid holidaysOn‑site child daycare, café, fitness centerApplicants Requesting AccommodationsOlympus is committed to the full inclusion of all qualified individuals. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1‑888‑659‑6787).Equal Employment Opportunity StatementIt is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin, citizenship status, religious creed, age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.#J-18808-Ljbffr