Senior Quality & Reliability Engineer

Siemens Healthineers

2d•Hybrid

About The Position

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.

Requirements

Bachelor’s degree or foreign equivalent in Biomedical Engineering, or a related field.
Five (5) years of experience in the job offered, as a Design Assurance Engineer, Compliance Engineer, or an acceptable alternate occupation.
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).

Responsibilities

Drive product quality and process compliance during new product introduction and post-market support across cross-functional teams.
Provide leadership for product design and development reviews with focus on product safety, performance reliability, and risk management.
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.