Manufacturing Mechanical Engineer II (Hybrid)

Nova Biomedical; Waltham (MA); On-site; USD 90,000 - 105,000; Full time

Benefits offered by this job

Hybrid and flexible work arrangements

Generous PTO and holidays

Tuition reimbursement

Company cafeteria subsidy in Waltham,

401k company match

Job summary

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 on‑time delivery of high‑quality products by investigating manufacturing issues and supporting process improvements.

Responsibilities include testing consumables, documenting variances, creating manufacturing docs, and assisting with product transfers.

Qualifications

• Bachelor of Science degree in Mechanical Engineering or Manufacturing Engineering required.
• Experience with manufacturing environments and engineering support roles.
• Advanced proficiency with Microsoft Office, Minitab, SAP, and MasterControl.
• Knowledge of FDA Quality System Regulations and ISO standards.

Responsibilities

• 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, DOE, PFMEA, and related studies.
• Research, specify, and procure equipment for manufacturing processes and assemblies.
• Design and construct tooling and fixtures for manufacturing processes.
• Modify existing production equipment to improve manufacturing performance.
• Assist with the transfer of new products and processes into manufacturing.
• Collaborate with R&D and other manufacturing engineers to develop scalable processes.
• Train assemblers and operators on new processes, assemblies, equipment, tooling, and production methods.
• Contribute to continuous improvement initiatives to reduce costs and cycle times.
• Evaluate and implement lean manufacturing techniques.

Skills

Microsoft Office

Minitab

SAP

MasterControl

SolidWorks

Education

Bachelor of Science in Mechanical/Manufacturing Engineering

Tools

SolidWorks

Job description

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 on‑time delivery of high‑quality products by investigating manufacturing issues and supporting process improvements.

Responsibilities include testing consumables, documenting variances, creating manufacturing docs, and assisting with product transfers.