Novozen Healthcare LLC · 12 hours ago
Manufacturing Engineer
Minnesota, United States
Contract
Onsite
Mid Level
4+ years expNovozen Healthcare LLC is seeking a skilled Manufacturing Engineer with experience in the medical device industry to support manufacturing operations, process validation, and new product introduction activities. The ideal candidate will develop and optimize manufacturing processes, lead process validation activities, and ensure compliance with FDA regulations and ISO standards.
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Hiring Manager
TARUN KUMAR
Responsibilities
Develop, implement, and optimize manufacturing processes for Class II/III medical devices
Lead and execute process validation activities including IQ, OQ, and PQ
Support equipment installation, commissioning, and qualification
Collaborate with R&D during design transfer and NPI activities to ensure manufacturability
Perform root cause analysis (RCA) for production issues and implement corrective and preventive actions (CAPA)
Author and review validation protocols, reports, SOPs, and work instructions
Conduct PFMEA and risk assessments to identify and mitigate manufacturing risks
Drive continuous improvement initiatives using Lean and Six Sigma methodologies
Ensure compliance with FDA regulations, ISO 13485, and cGMP requirements
Support internal and external audits and regulatory inspections
Qualification
Required
Bachelor's degree in Mechanical, Biomedical, Industrial, or related Engineering field
4–5 years of experience in manufacturing engineering within the medical device industry
Hands-on experience with IQ/OQ/PQ and process validation
Experience working in FDA-regulated and ISO 13485 environments
Strong understanding of GMP documentation and regulatory compliance
Experience with root cause analysis tools (5 Why, Fishbone, etc.)
Knowledge of PFMEA and risk management processes
Proficiency in MS Office; experience with Minitab, SAP, or similar systems preferred
Preferred
Experience with sterile manufacturing or cleanroom environments
Six Sigma certification (Green Belt preferred)
Experience supporting electromechanical or disposable medical devices
Company
Novozen Healthcare LLC
At Novozen Healthcare, we excel in bridging the gap between academics and industry.
201-500 employees
H1B Sponsorship
Novozen Healthcare LLC 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
2025 (47)
2024 (34)
2023 (20)
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
Vijay Kumar
Sr. Recruitment Partner
Company data provided by crunchbase