R&D Engineer II, Sustaining jobs in United States
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VERO Biotech · 5 hours ago

R&D Engineer II, Sustaining

VERO Biotech is dedicated to improving patient lives through innovative respiratory therapy technologies. The R&D Engineer II, Sustaining will be responsible for supporting production operations, troubleshooting manufacturing equipment, and driving continuous improvement initiatives while ensuring compliance with regulatory standards.

BiotechnologyHealth CareHealth DiagnosticsMedicalPharmaceutical
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H1B Sponsor Likelynote

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

Qualification

FDA regulationsProcess validationLean methodologiesSix Sigma certificationCMMS systemsERP/MRP systemsMES systemsTechnical writingProblem-solving skillsOrganizational skillsCommunication skillsAttention to detailProject managementTeam player

Required

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

Preferred

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

Company

VERO Biotech

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Vero Biotech is a biopharmaceutical company that commercializes inhaled nitric oxide delivery systems for healthcare providers.

H1B Sponsorship

VERO Biotech has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (1)

Funding

Current Stage
Late Stage
Total Funding
$234.64M
Key Investors
Petrichor Healthcare Capital ManagementMVM Life Science PartnersRunway Growth Capital
2023-01-11Series Unknown· $30M
2021-12-21Series E· $100M
2021-01-20Debt Financing· $50M

Leadership Team

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Brent V. Furse
Chief Executive Officer & President
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Roberto Cohen
Chief Financial Officer
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Company data provided by crunchbase