Note: The job is a remote job and is open to candidates in USA. Infotree Global Solutions is seeking a Senior Reliability Engineer to provide technical leadership and manufacturing reliability support across multiple sites. The role focuses on improving product quality, reducing reliability risks, supporting post-market quality activities, and driving continuous improvement for Cardiac Rhythm Management products, including pacemakers and leads.
Responsibilities
- Provide reliability engineering support to manufacturing sites and serve as a site representative
- Support manufacturing, sustaining engineering, product transfers, and process changes while assessing reliability risks
- Lead investigations into manufacturing nonconformances, quality issues, field concerns, and reliability events
- Perform root cause analysis and support corrective and preventive actions
- Analyze manufacturing and post-market data to identify failure trends, process variation, and reliability risks
- Support FMEA, FTA, DOE, statistical analysis, reliability modeling, and process capability analysis
- Identify and mitigate risks associated with manufacturing processes, suppliers, equipment, and materials
- Drive continuous improvement initiatives to improve product performance and manufacturing efficiency
- Collaborate with Manufacturing, Quality, Supplier Quality, Operations, Design Engineering, Regulatory Affairs, and Program Management teams
- Support quality and post-market deliverables, audits, inspections, and regulatory activities as needed
- Present technical findings and recommendations to site and program leadership
- Support multiple manufacturing sites and cross-functional projects and programs
Skills
- Bachelor's degree in Mechanical, Electrical, Biomedical, Industrial, Quality Engineering, or a related technical discipline
- 5–20 years of engineering experience, preferably in reliability, quality, manufacturing, product development, or a related engineering function
- Minimum 4 years of relevant engineering experience with a Bachelor's degree
- Experience supporting manufacturing operations in a regulated environment
- Strong experience with root cause analysis, corrective actions, reliability, quality, and statistical problem solving
- Medical device experience, particularly Cardiac Rhythm Management (CRM), pacemakers, leads, or implantable devices
- Experience in other highly regulated industries such as pharmaceutical, biotechnology, aerospace, or automotive
- Knowledge of FDA, ISO 13485, ISO 14971, and GMP requirements
- Experience with Minitab, JMP, ReliaSoft, SPC, Design for Reliability (DfR), DOE, FMEA, or FTA
- Experience with supplier quality and manufacturing validation
- Experience supporting multiple manufacturing facilities or global operations
- ASQ Certified Reliability Engineer (CRE) or equivalent certification
Benefits
- Onsite / Remote work arrangement
Company Overview
Company H1B Sponsorship