Manufacturing Mechanical Engineer II

Nova Biomedical:
One Global Brand. One Vision. Together under one name.

Advanced Instruments and Nova Biomedical are now united under one brand,
Nova Biomedical
, marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets.

Nova Biomedical is seeking a Manufacturing Mechanical Engineer II to provide technical floor support to reagent, sensor, and tubing manufacturing operations in Waltham, MA. This role will help ensure the on‑time delivery of high-quality products at an acceptable cost by investigating manufacturing issues, supporting process and product improvements, and transferring new products and processes into manufacturing.

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.
• Design and construct tooling and fixtures for manufacturing processes.
• Modify existing production equipment as needed to improve manufacturing performance.
• Assist with the transfer of new products and processes into manufacturing.
• Collaborate with Research and Development and other manufacturing engineers to develop methods and processes that support production scalability.
• Train assemblers and operators on new processes, assemblies, equipment, tooling, and production methods.
• Contribute to continuous improvement initiatives designed to reduce product costs and cycle times.
• Evaluate and implement lean manufacturing techniques.
• Collaborate with Manufacturing, Research and Development, Quality Assurance, Quality Control, Marketing, Accounting, Purchasing, Planning, and Distribution.
• Mentor and provide informal guidance to co‑op students and interns as needed.

• 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 Master Control.
• Basic proficiency with Solid Works.
• Knowledge of FDA Quality System Regulations and ISO standards.
• Experience providing hands‑on technical support within a manufacturing environment.
• Experience investigating and resolving manufacturing or product‑processing issues.
• Experience testing consumables, components, or products using analyzers or…