Manufacturing Process Specialist

6 hours ago

Bhavnagar, Gujarat, India beBeeManufacturing Full time ₹ 1,80,00,000 - ₹ 2,10,00,000
Job Title:

Manufacturing Process Specialist

We are seeking a skilled Manufacturing Process Specialist to join our team.

Key Responsibilities:

  • Review and validate engineering drawings for manufacturability, accuracy, and completeness as per the latest engineering standards.
  • Apply knowledge of medical device regulations and execute gap assessments, manufacturing print reviews, and remediation activities.
  • Participate in ideation activities to assess project scoping and viability through economic analysis, conflict analysis, and supplier quote validation.
  • Experienced in product sustenance engineering activities with expertise across design, manufacturing, production processes, and regulatory compliance. Skilled in coordinating with suppliers to resolve technical queries, ensuring timely and high-quality project delivery.
  • Conduct, review, and update models for tolerancing studies and dimensional variation analysis (1D/2D) using Creo-CETol or other tools.
  • Apply project management skills to plan, schedule, and monitor project activities efficiently, ensuring FTR & OTD excellence.
  • Collaborate with global stakeholders across regions like category managers, sourcing, PM, and other cross-functional teams as per the project needs.
  • Review and validate PPAP reports received from suppliers and assess if the technical specifications are met.
  • Well-versed with Engineering Change Management procedures using PDM/PLM software (Agile, Windchill, etc.).
  • DFMEA/PFMEA and design reviews to assess and mitigate design & Mfg risks.
  • Develop and refine detailed 2D drawings and 3D CAD models to support project requirements.
  • Design Remediation (Engineering Specification Gap Assessment).
  • Assist in developing Master Validation Plans, including process flow, OQ, and PQ.
  • Perform CPK (Process Capability Index) and ANOVA (Analysis of Variance) studies.
  • Conduct criticality analysis to ensure process reliability and quality.

Required Skills and Qualifications:

  • Strong understanding of medical device regulations and industry standards.
  • Excellent communication and interpersonal skills.
  • Ability to work effectively in a team environment.
  • Proven problem-solving and analytical skills.
  • Proficient in Creo-CETol or other relevant software tools.

Benefits:

As a Manufacturing Process Specialist, you will enjoy a competitive salary and benefits package, including comprehensive health insurance, retirement savings plan, and opportunities for career growth and professional development.

Others:

If you are a motivated and detail-oriented individual with a passion for manufacturing and process improvement, we encourage you to apply for this exciting opportunity.

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