Manufacturing Engineer Job at Novozen Healthcare LLC in Trenton

Job Title: Manufacturing Engineer Company: Novozen Healthcare LLC Job Description We are seeking an experienced Manufacturing Engineer to support manufacturing operations, process optimization, and continuous improvement initiatives within a regulated medical device environment. The ideal candidate will have strong experience in process development, validation, equipment troubleshooting, and cross‑functional collaboration to ensure safe, efficient, and compliant production. Key Responsibilities Lead and support manufacturing operations, ensuring processes meet quality, safety, and regulatory requirements (FDA, ISO 13485). Develop, optimize, and validate manufacturing processes, including protocol creation and execution for IQ/OQ/PQ. Troubleshoot equipment, tooling, and process issues to minimize downtime and improve reliability. Drive continuous improvement initiatives using Lean, Six Sigma, and root‑cause problem‑solving methodologies. Support new product introduction (NPI), including process planning, equipment qualification, and documentation. Create and maintain manufacturing documentation such as work instructions, SOPs, PFMEAs, control plans, and process flow diagrams. Collaborate with R&D, Quality, Regulatory, and Production teams on process changes, CAPA activities, and risk management. Manage suppliers and coordinate with vendors for tooling, fixtures, and equipment upgrades. Ensure compliance with cleanroom and GMP manufacturing standards. Required Skills & Experience 4–5 years of experience as a Manufacturing Engineer in the medical device industry. Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and GMP requirements. Hands‑on experience with process validation (IQ/OQ/PQ), equipment qualification, and test method validation. Proficiency with CAD/Solid Modeling tools (SolidWorks or similar). Experience with Lean manufacturing, Six Sigma, and data‑driven process improvement. Strong analytical, documentation, and troubleshooting skills. Excellent communication and collaboration abilities. Seniority Level Mid‑Senior level Employment Type Contract Job Function Manufacturing, Science, and Engineering Industries Medical Equipment Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at Novozen Healthcare LLC by 2x Get notified about new Manufacturing Engineer jobs in New Jersey, United States . #J-18808-Ljbffr