Manufacturing Mechanical Engineer II

Nova Biomedical - Waltham, MA

Hiring: Manufacturing Mechanical Engineer II Company: Nova Biomedical Location: Waltham, MA Job Posted Time: 2026-09-15 10:18:46 Employment Type: Hybrid Target Skills & Keywords : Assembly About the job Required Skills: •The Manufacturing Mechanical Engineer II will also contribute to investigations involving in-process and field-returned products to support continuous improvement. Although this position does not have formal direct reports, the individual may provide mentoring and informal oversight to co-op students and interns. •Provide day-to-day technical floor support to consumable manufacturing operations by investigating and resolving issues that arise during product manufacturing and processing. •Test consumables, including sensors, tubing, calibrators, and controls, for functionality using analyzers and production test platforms. •Measure and inspect components for form, fit, and function and support the disposition of nonconforming products. •Prepare Manufacturing Variances to document deviations and coordinate the required review and approval process. •Create and update manufacturing documentation, including Assembly Procedures, Test Procedures, Operating Instructions, Operating Procedures, drawings, and artwork, in compliance with Quality System Regulations and ISO standards. •Write and/or execute Installation Qualifications, Operational Qualifications, Performance Qualifications, validations, Design of Experiments, Process Failure Mode and Effects Analyses, Process Validation Master Plans, and continuous improvement studies or evaluations. •Research, specify, and procure equipment for new and existing manufacturing processes and assemblies. Qualifications: •Bachelor of Science degree in Mechanical Engineering or Manufacturing Engineering required. •3+ of relevant engineering experience desired. •Advanced proficiency with Microsoft Office, Minitab, SAP, and MasterControl. •Knowledge of FDA Quality System Regulations and ISO standards. •Demonstrated capacity to measure and inspect components for form, fit, and function. •Demonstrated capacity to research, specify, and procure equipment for manufacturing processes. •Understanding of lean manufacturing and continuous improvement practices. Compensation: •$90,000 - $105,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!