Reliability Engineer Cyient View all jobs Alberta Permanent Full-time 7 days ago Job Description:· Key Responsibilities· Reliability Planning & Targets· Translate user needs, clinical risks, and business goals into reliability requirements (e.g., MTTF/MTBF, mission profiles, wear-out models).· Develop Reliability Plans aligned to Design & Development phases and risk controls (ISO 14971).· Design for Reliability (DfR)· Partner with Systems, Electrical, Mechanical, and Software teams to design-in reliability (materials selection, derating, thermal/mechanical margining, design rules).· Lead DFMEA/PFMEA and ensure risk controls flow into design verification and process validation strategies.· Reliability Modeling & Data Analytics· Build and maintain reliability models (e.g., Weibull, exponential, lognormal), reliability growth (Duane/AMSAA), and usage profiles.· Analyze field performance, complaint trends, ORT/line yield, and supplier/CM quality metrics to identify improvement levers.· Accelerated & Environmental Testing· Plan/execute Accelerated Life Tests (ALT), HALT/HASS, high-stress screening, and environmental/transport profiles.· Define sample sizes, censoring strategies, stopping rules, and acceptance criteria using sound statistical methods (JMP/Minitab).· Verification/Validation & Compliance· Align reliability evidence with DHF/DMR and regulatory submissions (e.g., 510(k)/PMA, EU MDR Technical File).· Support IEC 60601 (safety), IEC 62304 (software), IEC 62366-1 (usability), and ISO 10993 (biocompatibility) touchpoints impacting reliability.· Manufacturing & Supplier/CM Interface· Define/oversee incoming, in-process, and end-of-line reliability screens (e.g., ORT) and process capability (Cp/Cpk).· Drive supplier quality improvements and cost-out/VAVE without compromising reliability.· Post-Market Reliability· Own the post-market reliability surveillance plan: complaint analysis, trend detection, CAPA, and field corrective actions.· Lead root-cause analysis (5-Whys, Ishikawa, Fault Tree) and implement containment, corrective, and preventive actions.· Documentation & Communication· Create clear plans, protocols, reports, and executive readouts; ensure traceability across URS/SRS ↔ Risk ↔ V&V.·· Required Qualifications· Bachelor's in Mechanical, Electrical, Biomedical, Systems, or related engineering; Master's preferred.· 5-8+ years (adjust as needed) of reliability/quality/test engineering experience in regulated hardware products; medical devices strongly preferred.Department:Healthcare and Life Sciences (NAM) AssociateSkills Required:Collaboration,Risk Management,Communication,Device DevelopmentDesirable Skills:Collaboration,Risk Management,Communication,Device DevelopmentDesignation:Associate Cyient Apply Now Forward this job to your email to apply later Save Share Follow this company
