Novozen Healthcare LLC · 1 day ago
Mechanical Engineer
New Jersey, United States
Contract
Onsite
Senior Level
5+ years expNovozen Healthcare LLC is seeking an experienced Mechanical Engineer to support manufacturing engineering activities for medical device products in a regulated environment. The role focuses on design support, process improvement, tooling and fixture development, and production support, collaborating closely with various teams to ensure compliant and scalable manufacturing processes.
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Hiring Manager
TARUN KUMAR
Responsibilities
Provide mechanical engineering support to Manufacturing Engineers for production lines, assembly processes, and equipment
Support transfer of products from R&D to manufacturing, including design for manufacturability (DFM) and design for assembly (DFA)
Design, review, and improve tools, fixtures, gauges, and assembly aids used in medical device manufacturing
Support process validation activities (IQ/OQ/PQ) and equipment qualification in compliance with FDA and ISO requirements
Troubleshoot manufacturing issues, perform root cause analysis, and implement corrective actions
Support engineering change orders (ECOs/ECNs) and documentation updates
Collaborate with Quality Engineering on nonconformances, CAPAs, and continuous improvement initiatives
Work with suppliers and contract manufacturers on component and process issues
Ensure compliance with GMP, FDA 21 CFR Part 820, ISO 13485, and internal procedures
Participate in continuous improvement, lean manufacturing, and cost-reduction initiatives
Qualification
Required
Bachelor's degree in Mechanical Engineering or related discipline
5+ years of mechanical engineering experience in the medical device industry
Strong experience supporting manufacturing and production environments
Hands-on experience with tooling, fixtures, and mechanical design
Knowledge of GMP, FDA regulations, ISO 13485, and design control requirements
Experience with ECOs, deviations, NCRs, and CAPA processes
Proficiency with CAD software (SolidWorks, Creo, or equivalent)
Strong problem-solving, documentation, and cross-functional collaboration skills
Ability to work onsite in the USA and communicate effectively with cross-functional teams
Preferred
Master's degree in Mechanical Engineering or related field
Experience with automation, semi-automated equipment, or assembly lines
Exposure to process validation (IQ/OQ/PQ) and equipment qualification
Lean Manufacturing / Six Sigma experience
Experience working with contract manufacturers and suppliers
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