Senior Manufacturing Engineer

7 days ago

Hyderabad, India Tek Support Full time

Position Overview:

We are seeking an experienced and results-driven Senior Manufacturing Engineer to lead the design, development, and optimization of manufacturing processes across our organization. This role will involve working closely with cross-functional teams, suppliers, and key stakeholders to drive manufacturing transfers, ensure process stability, and uphold compliance with regulatory and quality standards.


Key Responsibilities:

  • Process Design & Optimization: Lead the development and optimization of manufacturing processes, production layouts, and assembly procedures to enhance efficiency and quality. Collaborate on equipment installation and material handling systems.
  • Manufacturing Transfers: Oversee the preparation, review, and execution of validation plans, protocols, and procedures for manufacturing transfers, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), as well as Statistical Process Control (SPC).
  • Risk Mitigation & Management: Proactively identify operational risks and implement mitigation strategies to ensure process robustness and continuous improvement.
  • Cross-Functional Collaboration: Partner with internal teams and external suppliers to design, characterize, and qualify manufacturing processes with a focus on high capability and scalability.
  • Risk Assessments & Controls: Conduct comprehensive risk assessments (e.g., pFMEA), and develop detailed process flows, control plans, and operational sequences to drive consistent quality and efficiency in tool and equipment fabrication.
  • Compliance & Quality Standards: Ensure all manufacturing processes are fully compliant with design control processes, quality management systems, and regulatory standards such as ISO 13485, ISO 14971, and FDA 21 CFR Part 820.
  • Inspection & Testing Integration: Collaborate with quality and production teams to integrate rigorous inspection and testing protocols into manufacturing plans, ensuring adherence to quality and safety standards.


Qualifications:

  • Educational Background: Bachelor's degree in Mechanical Engineering, Production Engineering, or a related field.
  • Experience: A minimum of 6 years of proven experience in manufacturing and operations, with extensive exposure to medical device manufacturing or highly regulated industries.
  • Technical Expertise:
  • Deep understanding of validation processes, including Master Validation, IQ, OQ, and PQ.
  • Strong proficiency in Geometric Dimensioning and Tolerancing (GD&T) with the ability to interpret complex mechanical drawings.
  • Expertise in Lean Manufacturing and Six Sigma methodologies, with hands-on experience in process improvement initiatives.
  • Strong competence in statistical analysis, Design of Experiments (DOE), and process capability analysis.
  • Manufacturing Skills: Proficiency in various manufacturing methods such as machining, molding, and assembly, with a focus on precision and high-capability production.
  • Risk Management: Familiarity with risk management tools like Process Failure Modes and Effects Analysis (pFMEA) and Design Failure Modes and Effects Analysis (dFMEA).
  • Regulatory Knowledge: Demonstrated experience working within FDA 21 CFR Part 820 and ISO 13485-regulated environments.


Preferred Skills:

  • Strong analytical and problem-solving abilities with a continuous improvement mindset.
  • Excellent communication and collaboration skills to work effectively across multidisciplinary teams.
  • Proven ability to manage complex projects and meet critical deadlines while maintaining high standards of quality.

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