R&D Engineer II, Sustaining

VERO BIOTECH INC•Atlanta, GA

6d•Onsite

About The Position

Our Mission: At VERO Biotech, our mission is to improve the lives of patients by developing innovative technologies that support critical care and respiratory therapy through inhaled nitric oxide delivery in the acute care hospital setting or wherever nitric oxide treatment is needed. We strive to exceed customer expectations in terms of safety, efficacy, and value by focusing on the science, development, and commercialization of our innovations. The Manufacturing Engineer is a highly hands-on contributor responsible for supporting production operations through effective troubleshooting, maintenance, and improvement of manufacturing equipment and processes in a regulated combination product environment. 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. 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. Support supplier interactions related to equipment, tooling, and automation, including specifications, FAT/SAT participation, and issue resolution. Ensure adherence to safety requirements, GMPs, and regulatory standards while balancing the demands of a fast-paced startup manufacturing environment. Contribute to scaling manufacturing operations through equipment upgrades, line expansions, and process standardization efforts.

Requirements

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.
Commitment to excellence and high standards
Basic competence in subordinates’ duties and tasks
Strong organizational, problem-solving, and analytical skills
Ability to manage priorities and workflow
Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
Acute attention to detail
Demonstrated ability to plan and organize projects
Proven ability to handle multiple projects and meet deadlines
Good judgement with the ability to make timely and sound decisions
Creative, flexible, and innovative team player
Working knowledge of data collection, data analysis, evaluation, and scientific method.
Working knowledge and understanding of the basic principles, theories, concepts, and practices in the applicable area of engineering/technical specialization.

Nice To Haves

Six Sigma Green or Black belt certification preferred.
Experience with CMMS, ERP/MRP, or MES systems preferred.

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.
Support supplier interactions related to equipment, tooling, and automation, including specifications, FAT/SAT participation, and issue resolution.
Ensure adherence to safety requirements, GMPs, and regulatory standards while balancing the demands of a fast-paced startup manufacturing environment.
Contribute to scaling manufacturing operations through equipment upgrades, line expansions, and process standardization efforts.
Train and mentor Manufacturing Engineers I and manufacturing technicians on equipment operation, troubleshooting techniques, and best practices.