Minimum salary: $ 89,200; maximum salary: $ 169,50...
On-site
Design controls
Risk management iso 14971
Software quality iec 62304
This hybrid role is based at the Waltham, MA location and requires being on-site at least three (3) days per week
Job Summary
This hybrid role is based at the Waltham, MA location and requires being on-site at least three (3) days per week.
Serve as the technical authority within Quality for system integration, design decisions, risk management, and software development & validation.
The Senior Engineer will influence strategic quality initiatives, mentor junior engineers, and serve as a key resource in cross-functional teams to ensure product safety, regulatory compliance, and design robustness.
Matching Summary
This hybrid role is based at the Waltham, MA location and requires being on-site at least three (3) days per week.
Salary
Minimum Salary: $ 89200; Maximum Salary: $ 169500; Benefits: See www.bscbenefitsconnect.com
Skills & Requirements
Must-have
Design Controls
Risk Management ISO 14971
Software Quality IEC 62304
Quality System Regulations 21 CFR 820
Root Cause Analysis
Cross-functional collaboration
Nice-to-have
Mentoring junior engineers
Agile development methodologies
Cardiac mapping systems experience
Continuous improvement
Key Requirements
Bachelor's degree in technical discipline
6+ years of experience
Experience with FMEAs and Hazard Analyses
Experience leading root cause analysis and CAPA investigations