Mechanical Engineer - Manufacturing/ Process Development

Department: Engineering / New Product Development (NPD)
Location: MAJiK Medical Solutions Pvt ltd , M46, Sultanpur
Experience: FRESHER
Education: Bachelor’s Degree in Mechanical / Biomedical / Industrial Engineering (Required)

Job Summary:

The NPD Manufacturing Engineer will be responsible for supporting the design, development, and transition of new medical device products from concept to manufacturing. This includes process design, validation, equipment specification, and continuous improvement for manufacturability, quality, and cost-effectiveness.

Key Responsibilities:

• Collaborate with R&D and design teams to ensure designs are manufacturable.
• Develop, evaluate, and optimize manufacturing processes for new products.
• Support prototype development, design for manufacturability (DFM), and scalability to production.
• Create and update process documentation, work instructions, and validation protocols (IQ/OQ/PQ).
• Conduct feasibility studies and process capability assessments.
• Select and qualify tools, jigs, and fixtures for production.
• Assist in regulatory documentation and compliance (ISO 13485, FDA QSR).
• Train production staff and technicians on new processes and equipment.
• Support pilot builds and engineering builds.
• Ensure smooth handover from development to manufacturing.

Skills & Competencies:

• Strong knowledge of NPD and manufacturing engineering principles.
• Experience with medical device development (preferred).
• Proficiency in CAD (SolidWorks, AutoCAD) and MS Office.
• Hands-on knowledge of validation (IQ/OQ/PQ) and process qualification.
• Good understanding of GMP, ISO 13485, and regulatory requirements.
• Problem-solving mindset and ability to work in cross-functional teams.
• Excellent verbal and written communication skills.

Job Type: Full-time

Pay: ₹16,000.00 - ₹20,000.00 per month

Benefits:

• Health insurance
• Provident Fund

Schedule:

• Day shift

Supplemental Pay:

• Yearly bonus

Work Location: In person