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Medtronic Recruitment Drive 2026 | Medtronic Hiring Mechanical/Production Engineer
- Company Name
- Medtronic
- Company Website
- http://www.medtronic.com/
- Experience
- 6-8 Years
- Job Role
- Manufacturing Engineer II
- Job Type
-
- Experienced
- Job Location
-
- Nanakramguda Hyderabad
- Skills
-
- Good Communication Skill
- Education
-
- BE/BTech
- Branch
-
- Mechanical Engineering
- Production Engineering
- Job will expire on
- 23 Nov 2026
About Company
Eligibility Criteria
- Bachelor’s degree in mechanical OR 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).
- 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 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.
- 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.
Job Description
- 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).
- Through understanding of process validation procedures.
- Statistical tools, theories, analysis needed for process validation.
- CpK, Cp, Pp, PpK.
- Normal curve and other distributions.
- igma 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 Manufacturing sites & supplier(s) to design, characterize and qualify high capability processes producing consistent finished products. This may include supporting process risk assessments (pFMEA), establish process flows, and develop 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.
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