
Senior Manufacturing Engineer
10 hours ago
Job Title: Manufacturing Engineer – Medical Devices (Senior/Principal Level)(Remote)
Location:
Hyderabad, IND
Employment Type:
Part-time
Position Summary:
We are seeking an experienced
Manufacturing Engineer Trainer
with
10+ years of hands-on expertise in the medical device industry
to support and enhance our manufacturing operations. The ideal candidate will have a proven track record in process development, validation, scale-up, and continuous improvement while ensuring compliance with
FDA, ISO 13485, and GMP regulations
.
Key Responsibilities:
- Lead the design, development, and optimization of manufacturing processes for Class II/III medical devices.
- Drive process validation activities, including
IQ, OQ, PQ, and Test Method Validation
in compliance with regulatory requirements. - Collaborate with R&D, Quality, and Regulatory teams to ensure smooth transfer of products from design to full-scale manufacturing.
- Identify, analyze, and resolve complex manufacturing challenges to improve efficiency, cost-effectiveness, and product quality.
- Oversee equipment selection, installation, and qualification (IQ/OQ/PQ), ensuring robust process capability.
- Lead continuous improvement initiatives using Lean, Six Sigma, and other structured problem-solving methodologies.
- Provide technical leadership and mentorship to junior engineers and technicians.
- Support audits (internal, supplier, and regulatory) by preparing technical
documentation and ensuring compliance with ISO 13485, FDA 21 CFR Part 11/820, and EU MDR
. - Manage
nonconformance investigations, root cause analysis, and corrective/preventive actions (CAPA)
. - Collaborate with suppliers to ensure incoming materials meet specifications and quality standards.
Qualifications:
- Bachelor's degree
in Mechanical, Biomedical, Manufacturing, or related Engineering field (Master's preferred). - 10+ years of progressive experience
in manufacturing engineering within the medical device industry. - Strong background in
process validation, design transfer, and GMP manufacturing operations
. - Proficiency in
Lean Manufacturing, Six Sigma
(Green/Black Belt preferred). - Experience with CAD software, statistical analysis tools, and ERP/MES systems.
- In-depth knowledge of
FDA, ISO 13485, ISO 14971, and EU MDR regulations
. - Demonstrated leadership in cross-functional teams and mentoring junior staff.
- Excellent communication, documentation, and project management skills.
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