Senior Quality & Reliability Engineer

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Dimensions parts or elements for a technical solution as to the requirements and related to a specific technical field.

External Website Posting Company:

Siemens Medical Solutions USA, Inc.

Location:

22010 SE 51st St, Issaquah, WA 98029

Position Title:

Senior Quality & Reliability Engineer Salary:

$144,477-$ 206,870 / year

Hours:

Monday - Friday, 9:00am to 5:00pm

Summary of Duties:

Drive product quality and process compliance during new product introduction and post-market support across cross-functional teams, including usability, hardware, software, systems, peripherals, and reliability engineering. Provide leadership for product design and development reviews with focus on product safety, performance reliability, and risk management throughout the product lifecycle. Serve as subject matter expert in design control, including design inputs, design reviews, verification and validation practices, acceptance criteria, and compliant electronic records. Lead quality and compliance investigations, perform root cause analysis and ensure corrective and preventive actions are implemented with rigor. Partner with engineering and production teams to identify and resolve design non-conformance issues. Define and monitor critical-to-quality parameters and key performance indicators to improve product quality and reduce cost of poor quality. Draft and implement software reliability plans across ultrasound product lines. Define and extract reliability key performance indicators (KPIs) for monitoring field performance and system reliability. Present reliability metrics and outcomes across global platforms. Lead design failure mode and effects analyses (dFMEAs), with emphasis on strengthening early design and feature development phases. Establish and execute reliability growth testing and reliability demonstration testing, using statistical analysis and mean time between failures (MTBF) data. Collaborate with cross-functional teams including Risk Management, Regulatory Affairs, Customer Service, Post Market Surveillance, Supplier Quality, and Compliance Engineering to identify and mitigate safety and effectiveness issues. Support audits, inspections, complaint handling, CAPA management, and continuous improvement of the quality management system in accordance with international standards such as 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, and

MDSAP. 25

% Domestic and International travel. Hybrid work permitted.

Qualifications:

The position requires a Bachelor's degree or foreign equivalent in Biomedical Engineering, or a related field and five (5) years of experience in the job offered, as a Design Assurance Engineer, Compliance Engineer, or an acceptable alternate occupation. Position requires experience with the following skills: Knowledge of international medical device regulations and quality standards, including

FDA 21 CFR 820, ISO 13485, ISO 14971, IEC

62304, MDSAP, and MDR. Experience with design control processes, including design input, design review, verification and validation, and electronic records/signatures. Proficiency in risk management techniques, including conducting design failure mode and effects analysis (dFMEA). Expertise in corrective and preventive action (CAPA), root cause analysis, and resolution of design non-conformance. Ability to define, monitor, and analyze critical-to-quality (CTQ) parameters and reliability/quality key performance indicators (KPIs). Experience drafting and implementing software reliability plans. Experience establishing and executing reliability growth testing and reliability demonstration testing, including statistical analysis using mean time between failures (MTBF) data. Familiarity with complaint handling, post-market surveillance, supplier quality management, and regulatory audits/inspections. Strong communication and leadership skills to work across cross-functional teams (engineering, manufacturing, risk management, regulatory, and service). Who we are : We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. To find out more about Siemens Healthineers businesses, please visit our company page here .

Equal Employment Opportunity Statement:

Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. EEO is the

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