Sr. Process/Reliability Engineer - Medical Devices

Job ID: 615227

Our client, a leading Medical Device company, is seeking a mid/senior level Process/Reliability Engineer who is able to work onsite at their North Haven, CT location (onsite 3x/week, home based 2 days). See below for other details!

Summary:

The Reliability Engineer will assume the role of Process Manager and be responsible for overseeing and optimizing the Issues Triage and Investigation (ITI) processes, which directs our issues handling and failure investigation workflows.

This role will focus on improving process efficiency, enhancing communication between cross-functional teams, and ensuring that the process effectively facilitate the resolution of issues. The Process Manager will work closely with teams such as Fleet Management, Quality, Operations, Reliability Testing and Field Service to drive continuous improvements.

Top 3 Skills Needed:

1. Proficiency in statistical analysis methods and tools to monitor trends, identify patterns, and predict emerging issues
2. Ability to analyze data, create and track key performance indicators (KPIs), and make data-driven decisions to enhance process effectiveness
3. Experience using statistical techniques to assess process performance and guide corrective actions based on quantitative insights.

Key Responsibilities:

• Process Development & Optimization: Design, implement, and continually refine the ITI processes and cross-functional communication. Identify bottlenecks, inefficiencies, and areas for improvement
• Issue Monitoring & Analysis: Monitor reported issues across various sources. Categorize issues, identify trends, and analyze underlying causes to proactively address emerging problems
• Stakeholder Collaboration: Act as a central point of contact for teams across the organization, ensuring that process updates are communicated effectively, and all stakeholders are aligned
• Performance Monitoring: Regularly track and analyze process performance metrics (e.g., throughput, resolution times, error rates) to measure the effectiveness of current processes and identify opportunities for enhancement
• Compliance & Risk Management: Ensure all processes are compliant with FDA regulations, quality standards, and internal policies
• Training & Support: Provide training and support to team members on process improvements and best practices. Ensure that all staff understand their roles within the process and the importance of adhering to standards
• Cross-Functional Leadership: Lead and facilitate cross-functional meetings to address process improvements, drive initiatives, and foster collaboration among teams such as R&D, Manufacturing, Quality, and Field Service
• Documentation & Reporting: Develop, maintain, and update process documentation to ensure clarity and consistency. Provide regular reports to senior management on process performance, key metrics, and any necessary adjustments
• Trending & Predictive Analysis: Utilize data from reported issues to establish trends, predict potential systematic problems, and work with teams to implement preventive measures

Education Required:

Bachelor Degree/Master Degree in Biomedical Engineering, Computer Science, Electrical or Software Engineering

Years' Experience Required:

Senior - Bachelor Degree (4 yrs), Master Degree (2 yrs)

Principal - Bachelor Degree (7 yrs), Master Degree (5 yrs)