Role: Senior Manufacturing Engineer

Years Experience Required: 8 to 15 Years

Location: Hyderabad

Skillset:

- Strong experience in manufacturing engineering with expertise in process development, validation, and continuous improvement.
- Hands-on experience in medical device, regulated manufacturing, or precision engineering environments, including NPI and production support.
- Proven ability to drive productivity, quality, using Lean Manufacturing, Six Sigma, and problem-solving methodologies.

Responsibilities may include the following and other duties may be assigned.

- Prepare, review, revise, and maintain controlled Manufacturing Engineering documentation throughout the product lifecycle.
- Manage document control activities, including document creation, review, approval, release, revision, and archival within PLM, ERP, and Document Management Systems.
- Support Engineering Change Management (ECR/ECO/ECN/MCO) by preparing and implementing engineering change documentation.
- Maintain product configuration, manufacturing master data, and product attributes to ensure data accuracy and integrity.
- Prepare, review, revise, and maintain process risk management activities by maintaining PFMEA and other manufacturing risk assessment documentation.
- Ensure engineering documentation complies with QMS, Positive Documentation Practices (GDP), ISO 13485, FDA/QMSR, MDR, and internal quality requirements.
- Collaborate with Manufacturing Engineering, Quality, Operations, Design Engineering, Regulatory Affairs, Supply Chain, and Facilities to support engineering deliverables.
- Coordinate cross-functional document reviews, approvals, and documentation status to ensure timely project execution.
- Support New Product Introduction (NPI), manufacturing transfer, process improvement, validation, and sustaining engineering projects.
- Prepare or review necessary validation plans, protocols, and procedures for successful completion of transfer activities. (IQ, OQ, PQ, MVP/MVR, SPC control, GRR, etc...)




- Through understanding of process validation procedures
- Statistical tools, theories, analysis needed for process validation.
- Normal curve and other distributions
- Sigma levels
- Qualification pass/fail criteria.
- Design of MSA and understanding of statistical process involved.

Attribute Agreement Analysis

- Contribute to achieving Core Team goals & objectives and actively participate in Core Team meetings.
- Collaborate with Internal Mfg. Sites & supplier(s) to design, characterize and qualify high capability processes producing consistent finished products.
- This may include supporting process risk assessments (pFMEA), establishing process flows, developing control plans.
- PFMEA, RPN determination, RCA, FTA and other risk management and non- conformance analysis
- Should maintain accountability and successfully deliver projects/tasks assigned.
- Must learn and ensure compliance with all GBU design control processes and procedures.

Must Have: Minimum Requirements

- Bachelor’s degree in mechanical/ production engineering or equivalent with 6 to 8 years of experience in manufacturing and operations.
- Experience with risk management, including but not limited to Process Failure Mode Effects Analysis (pFMEA), Design Failure Mode Effects Analysis (dFMEA), fault tree analysis, or other risk management tools.
- Prepare, review, revise, and maintain controlled Manufacturing Engineering documentation throughout the product lifecycle, (CP, Process sheets, Etc..)
- Product Lifecycle Maintenance and Product Labeling Updates
- Strong understanding of Master Validation,



including Validation Master Planning, Installation Qualification, Operational Qualification, and Performance Qualification.
- Knowledge on GD&T; & experience in interpreting mechanical drawings.
- Working understanding of statistics, including sample size selection, data distribution analysis, capability calculations, Design of Experiments (DOE), and Analysis of Variation.
- Strong Knowledge in Lean Manufacturing / Six Sigma methodologies including Value Stream Mapping, Line Balancing, FTQ, 8Wastes, 5S etc.
- High degree of understanding/knowledge of Machining, Molding, Grinding, Forming, Assembly, Welding, Finishing, Cleaning, Passivating, Anodizing, Shot Peening, Mass Media Operations, Coatings, EDM, Casting, Forging, Polishing
- Good understanding on inspection methods and procedures. (Test Method validation TMV)
- Experience in FDA 21 CFR Part 820 Medical Device Manufacturing, or ISO 13485 is preferred.
- Knowledge on Engineering Change management processes and PLM tools such as Agile, PTC Windchill is preferred. (Any PLM)
- Good interpersonal skills and ability to independently handle projects with minimal supervision.
- Ability to manage/interact with suppliers and contract manufacturers.

Nice to Have

- Medical device product development and/or manufacturing experience and a strong understanding of FDA, ICH and IEC standards
- Experience across the entire product lifecycle.
- Experience working in a highly regulated industry (e.g. medical device, pharmaceutical, automotive)
- Project engineering or program management experience in a new product development and/or manufacturing environment
- Demonstrate strong problem-solving skills and the ability to ask critical questions without being the subject matter expert.
- Ensure structured problem methods and predictive engineering principles are consistently and rigorously applied, such as Design for Six Sigma, Lean Manufacturing, DFMA, DRM, FTQ or similar concepts.

📌 Senior Manufacturing Engineer (Hyderabad)
🏢 Horizontal Integration
📍 Hyderabad