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.
A Day in the LifeBe a part of the Medtronic Engineering and Innovation center (MEIC) by applying your skills to the growth and development of CST Ops under Global manufacturing group team within MEIC.
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.
- Review line layout set-up, Cycle times, Takt Times, Line balancing, production flows, time studies, apply lean principles to line layout.
- 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.
- Thorough knowledge and effective application of Design for Manufacturability, Design for Inspectability, Design for Test, Design for Reliability SPC, Process Control Plans, Gauging applications
- 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 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.
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, together.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
About MedtronicWe lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here
