Manufacturing Enginer Ii

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

As a member of GO & SC group you will collaborate closely with all the necessary stakeholders on the assigned tasks and projects including your counterparts in the US to ensure timely and successful completion of the same
**PRIMARY RESPONSIBILITIES**
Responsibilities may include the following and other duties may be assigned.
- Generating Manufacturing Transfer Deliverables (Plans and Reports)
- Working with Stakeholders to set Manufacturing Process / Transfer & related deliverables.
- Review of Design Specifications for completeness
- Review of Design Verification and Validation documentation
- Review of Design Input-to-Output Traceability Matix
- Supporting to manufacturing processes, procedures and production layouts for assemblies, and equipment installation.
- Key Process Parameters to monitor production efficiency.
- Capacity analysis using monte-Carlo simulation.
- Labor, material burden, scrap analysis
- DFM/A using Boothroyd Dewhurst method.
- Implementation of control charts, run charts etc. to oversee production line.
- Support in the execution of transfer and readiness for transfer by partnering with facilities and suppliers for point of contact support.
- Identify and communicate Operations and Program risks. Drive risk mitigation activity as necessary.
- 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.
- CpK, Cp, Pp, PpK
- Normal curve and other distributions
- Sigma levels
- Qualification pass/fail criteria.
- Design of Experiments, 1,2,3 factor studies.
- 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.
- Review existing product documentation to identify and remediate risks before manufacturing transfer to suppliers.

**Must Have: Minimum Requirements**
- Bachelor’s degree in mechanical/ production engineering or equivalent with 6 to 8 years of experience in manufacturing and operations.
- 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 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.
- 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 mínimal 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
- Ensure structured problem methods and predictive engineering principles are consistently and rigorousl