Manufacturing Engineer II — Process & Validation Expert

NOVA Biomedical GmbH; Northern, Billerica (KY, MA); Hybrid; USD 100,000 - 130,000; Full time

Benefits offered by this job

Hybrid work arrangements

401k match

Generous PTO and holidays

Job summary

Nova Biomedical is seeking a Manufacturing Engineer to support Point of Care meter manufacturing. You will help develop, design and validate equipment and processes, and write or update all related documentation for POC products.

Responsibilities include IQ/OQ/PQ/VQ, DOE, PFMEA, and continuous improvement projects. You will train operators, transfer products to manufacturing, and collaborate with R&D to optimize production costs and quality.

Qualifications

• 3–5 years of experience in a Manufacturing environment (medical preferred).
• Experience writing/maintaining manufacturing docs (DWGs, BOMS, SOPs).
• Ability to write and execute IQ/OQ/PQ/VQ and DOE.

Responsibilities

• Update and create manufacturing documentation (AP/TP/OI/OP/BOM/DWG/Artwork) per QSR/ISO standards.
• Lead/perform IQ, OQ, PQ, validations, DOE, PFMEA, validation plans and continuous improvement studies.
• Provide technical floor support to resolve manufacturing issues and improve processes.

Skills

Manufacturing engineering

IQ/OQ/PQ

Documentation

Process improvement

Problem solving

Tools

DOE

PFMEA

Job description

Nova Biomedical is seeking a Manufacturing Engineer to support Point of Care meter manufacturing. You will help develop, design and validate equipment and processes, and write or update all related documentation for POC products.

Responsibilities include IQ/OQ/PQ/VQ, DOE, PFMEA, and continuous improvement projects. You will train operators, transfer products to manufacturing, and collaborate with R&D to optimize production costs and quality.