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 LifeAs 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
Responsibilities may include the following and other duties may be assigned.
- Working with Stakeholders to set Manufacturing Process / Transfer & related deliverables.
- Supporting to designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining, and material handling.
- 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...)
- Contribute to achieving Core Team/ Project team goals & objectives and actively participate in Core Team/Project 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.
- Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
- May incorporate inspection and test requirements into the production plan
- Should maintain accountability and successfully deliver projects/tasks assigned.
- Must learn and ensure compliance with all GBU design control processes and procedures.
- Knowledge about ISO13485, ISO14971.
Required Knowledge and Experience
- Bachelor’s degree in mechanical/ production engineering or equivalent with 8 to 10 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.
- Thorough knowledge and effective application of Design for Manufacturability, Design for Inspectability, Validation Protocol and Report creation, SPC, Process Control Plans, MSA, Gauging applications, design, and construction, Sampling methodologies, Data Analysis
- 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)
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.
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
