Job Title: Sr. R&D Sustaining Engineer
Job Number: 37327
Location: Atlanta, Georgia
Job Description
This role focuses on rapidly diagnosing and resolving equipment, process, and yield issues to minimize downtime and maintain compliant production. Partnering closely with Operations, Quality, and R&D, the Manufacturing Engineer supports production readiness and drives continuous improvement while ensuring compliance with FDA, ISO 13485, and internal quality system requirements. The ideal candidate is comfortable working on the manufacturing floor and with chemical processes, balancing immediate production support with longer-term equipment reliability and process improvement to support scaling operations while maintaining product quality and patient safety.
Responsibilities
- Provide hands-on manufacturing floor support to independently troubleshoot and resolve equipment, tooling, and process issues impacting production, yield, and quality.
- Diagnose and correct mechanical, electrical, pneumatic, and basic controls/software issues; perform structured root cause analysis and implement effective corrective and preventive actions.
- Serve as equipment owner for assigned manufacturing systems, including setup, calibration, maintenance coordination, performance monitoring, and reliability improvement.
- Lead and execute equipment and process validation activities (IQ/OQ/PQ) with minimal supervision, ensuring compliance with FDA, ISO 13485, and internal quality system requirements.
- Collaborate with Quality to investigate nonconformances, deviations, and CAPAs related to manufacturing equipment and processes.
- Support new product introductions and engineering changes by partnering with R&D and Operations to ensure manufacturability, scalability, and equipment readiness.
- Analyze production data, downtime, and yield trends to identify issues and drive continuous improvement initiatives using lean and data-driven methodologies.
Required Skills
- Bachelor’s degree (B.S.) in Engineering or equivalent in related field.
- Two to five years related experience or equivalent, FDA regulated (210/211/820).
- Two to four years of related experience leading a team of technicians and/or engineers
- Excellent written and oral communication skills across all levels – technicians to executives.
- Demonstrates strong technical writing and investigative writing capability.
- Familiarity with process validation, change control, and equipment qualification.
- Six Sigma Green or Black belt certification preferred.
- Experience with CMMS, ERP/MRP, or MES systems preferred.