Job Description

Manufacturing Engineer ID: 20241101

Job Location: Saswad - Pune

IntegriMedical Private Limited (IMPL) is a medical device manufacturing company. We manufacture global standard medical products used by Medical Practitioners (General & Specialists), Hospitals, Health Clinics working in different branch of medicine.

Employees are the key to success in our organization. We value our employees and their skills in furthering the cause of helping lives. Thorough leadership, robust work planning methodology and exceptional customer service are the key enablers of our success.

POSITION DESCRIPTION

: IMPL is looking for a Manufacturing Engineer, and will be responsible for designing, optimizing, and improving the manufacturing processes for medical devices. This role will involve working closely with cross functional teams to ensure the efficient and cost-effective production of high-quality medical products, while adhering to stringent regulatory standards (e.g., ISO 13485, FDA requirements).

POSITION RESPONSIBILITIES

:

? Design, develop, and implement manufacturing processes and procedures for medical device production.

? Analyse existing manufacturing processes and identify opportunities for optimization, cost reduction, and efficiency improvements.

? Work with product development teams to ensure manufacturability of new products.

? Develop process flows, work instructions, and standard operating procedures (SOPs) for production teams.

? Support the validation of manufacturing processes and equipment, ensuring compliance with FDA, ISO 13485, and other relevant regulatory standards.

? Lead process characterization and validation efforts, including Process FMEA (Failure Mode Effects Analysis) and risk management activities.

? Ensure compliance with Good Manufacturing Practices (GMP) and other quality standards throughout production.

? Implement continuous improvement initiatives (CPI) in the production environment.

? Conduct machine qualifications and maintain production equipment to ensure reliable, high-quality output

? Work closely with Quality Assurance, R&D, and Supply Chain teams to ensure seamless product launches and efficient production.

? Maintain detailed records of process changes, equipment modifications, and other manufacturing related activities in compliance with quality systems and regulatory requirements.

DESIRED/PREFERRED QUALIFICATIONS:

Graduate / PG Engineer in Mechanical, Biomedical, Production and Instrumentation 2 to 5 years of related work experience in the medical device industry, with Design and Development Working knowledge of FDA and other regulatory authorities with experience supporting compliance. Quality Systems development, implementation, and training experience Oral and Verbal English communication skills is must. Knowledge International Quality Standards, applied to medical device industry Knowledge of Microsoft Word, Office, Power point and Excel Strong attention to detail and good analytical skills and critical thinking skills
Job Type: Full-time

Pay: From ?250,000.00 per year

Work Location: In person