Manufacturing Process Engineer

7 years

0 Lacs

Posted:4 days ago| Platform: Linkedin logo

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Job Type

Full Time

Job Description

We’re Hiring: Manufacturing / Process Engineer

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Manufacturing/Process Engineer (3–7 years)

What You’ll Work On:

🔹 Designing mechanical components, assemblies, jigs, fixtures & test fixtures

🔹 Creating 3D models, 2D drawings & engineering documentation

🔹 Conducting GD&T, tolerance analysis & design reviews

🔹 Supporting DFM/DFA, prototype builds & manufacturing troubleshooting

🔹 Preparing SOPs, work instructions, inspection criteria & calibration guidelines

🔹 Working with QMS (ISO 13485, ISO 14971, FDA, MDR) & driving compliance

🔹 Supporting risk management (FMEA), CAPA, RCA & non-conformance handling

🔹 Coordinating with suppliers for quality, qualification & audits

🔹 Maintaining PLM documentation, DHFs & version control records

Who We’re Looking For:

✔ Bachelor’s degree in Mechanical/Biomedical Engineering

✔ 3–7 years of experience in Design, Manufacturing, or Quality Engineering

✔ Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR & QMS documentation

✔ Hands-on with CAD tools (SolidWorks, Creo, CATIA, NX) & PLM systems

✔ Expertise in DFM/DFA, GD&T, tolerance analysis & engineering calculations

✔ Experience in medical devices or regulated industries (preferred)

Key Competencies:

🔹 Strong mechanical design & problem-solving skills

🔹 Quality-focused mindset with attention to detail

🔹 Excellent documentation & communication abilities

🔹 Collaborative, adaptable & process-driven

🔹 Passion for continuous improvement

If you're ready to contribute to high-quality, regulatory-compliant medical device engineering, we’d love to hear from you!

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