Manufacturing Mechanical Engineer II - Process & Validation

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

Benefits offered by this job

401k match

Bonus program

PTO & holidays

Hybrid work arrangements

Job summary

Nova Biomedical Corporation seeks a Manufacturing Mechanical Engineer II to provide technical floor support to reagent, sensor, and tubing manufacturing operations in Waltham, MA, ensuring on-time delivery of high‑quality products at acceptable cost by troubleshooting issues and supporting process improvements.

This position also contributes to investigations of in‑process and field‑returned products, mentors co‑ops and interns informally, and collaborates with R&D and other manufacturing

Qualifications

• BS degree in Mechanical or Manufacturing Engineering required.
• 3+ years of relevant engineering experience preferred.
• Proficiency with SAP, MasterControl, and MS Office.
• Basic proficiency with SolidWorks.
• Knowledge of FDA QSR and ISO standards.
• Experience in manufacturing environment and process validation.

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, 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.

Skills

MS Office

Minitab

Strong communication

Cross-functional collaboration

Engineering problem-solving

Education

Bachelor of Science in Mechanical Engineering

Tools

SAP

MasterControl

SolidWorks

Job description

Nova Biomedical Corporation seeks a Manufacturing Mechanical Engineer II to provide technical floor support to reagent, sensor, and tubing manufacturing operations in Waltham, MA, ensuring on-time delivery of high‑quality products at acceptable cost by troubleshooting issues and supporting process improvements.

This position also contributes to investigations of in‑process and field‑returned products, mentors co‑ops and interns informally, and collaborates with R&D and other manufacturing