Senior Manufacturing Engineer

Horizontal Integration; Hyderabad; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Horizontal Integration in Hyderabad is seeking a Senior Manufacturing Engineer with 8 to 15 years of experience to lead process development, validation, and continuous improvement in a regulated medical-device context. You will drive PFMEA, transfer activities, and cross-functional collaboration to ensure data integrity and GMP/GDP compliance.

The role requires strong knowledge of Lean/Six Sigma, PLM/ERP environments, and the ability to manage documentation throughout the product lifecycle,

Qualifications

• Bachelor's degree in mechanical/production engineering or equivalent.
• Experience with PFMEA, DFMEA, fault tree analysis, or other risk tools.
• Experience maintaining manufacturing documentation across product lifecycle.
• Strong validation background including IQ/OQ/PQ and GMP/GDP awareness.
• Knowledge of GD&T and reading mechanical drawings.
• Statistics familiarity: sampling, data distribution, DOE, capability analysis.
• Lean/Six Sigma expertise with value stream mapping, line balancing, FTQ, 5S.

Responsibilities

• Prepare, review, revise, and maintain controlled Manufacturing Engineering documentation.
• Manage document control using PLM/ERP systems.
• Support ECR/ECO/ECN/MCO processes with engineering change docs.
• Maintain product configuration and master data accuracy.
• Maintain PFMEA and other risk docs; ensure QMS/GDP/ISO13485/FDA/MDR compliance.
• Collaborate with multiple functions to support engineering deliverables.
• Coordinate cross-functional reviews and approvals for timely project execution.
• Support NPI, manufacturing transfer, process improvement, validation, and sustaining projects.
• Prepare validation plans and protocols (IQ/OQ/PQ, MVP/MVR, SPC, GRR).
• Apply statistical thinking; understand normal distributions, sigma levels, and MSAs.

Skills

Process development

Validation

Continuous improvement

Lean Manufacturing

Six Sigma

Problem solving

NPI

Production support

Regulated manufacturing

QMS ISO13485

Education

Bachelor's in mechanical/production

Tools

Agile PLM

PTC Windchill

Job description

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, Good 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.