Senior Manufacturing Engineer

Medtronic Inc. Louisville , CO 80028

Posted 6 days ago

Senior Manufacturing Engineer

Careers that Change Lives

Impact patient outcomes. Come for a job, stay for a career.

The Restorative Therapies Group (RTG) is looking for a Senior Manufacturing Engineer to join the Contract Manufacturing (CM) Supplier Excellence engineering team. The Senior Manufacturing Engineer is responsible to provide manufacturing engineering support to a portfolio of electronic products and/or disposable medical products sourced through Medtronic's contract manufacturing partners. Responsibilities will include process development, process changes/improvements, component/material development, sustaining engineering, continuous improvement, and project management. This role includes interfacing with suppliers and Medtronic business partners and applying the requirements of Medtronic's applicable Quality Management System (QMS) policies and procedures.

Day in the life:

  • Ensures all engineering activity is in full compliance with applicable Medtronic quality system requirements, regulatory approvals, and other agency requirements as-identified.

  • Collaborate with suppliers to design, characterize and qualify high capability processes producing consistent finished device medical products. This may include supporting process risk assessments (pFMEA), establishing process flows, developing control plans, conducting process validations (IQ, OQ, PQ), and setting product acceptance criteria.

  • Strong understanding of Master Validation, including Validation Master Planning, Installation Qualification, Operational Qualification, and Performance Qualification.

  • Lead and implement data-driven quality and manufacturing improvement for product design, assembly process, and supply chain management.

  • Identify and mitigate potential supply risks and manufacturing risks to ensure continuity of production supply. Ability to lead cross functional resolution for manufacturing issues and production line-down occurrences.

  • Working understanding of statistics, including sample size selection, data distribution analysis, capability calculations, Design of Experiments (DOE), and Analysis of Variation.

  • Plans, directs and implements all aspects of the RTG Contract Manufacturing engineering activity in support of annual goals and all project deliverables.

  • Continuous improvement as a method for identifying opportunities for streamlining processes and reducing waste. Applying Lean principals as a means to create value for customers with fewer resources to provide value through value creation process that eliminate waste. Controlling variation through application of a set of techniques to improve processes by reducing the probability that an error or defect will occur.

  • Supports the Engineering Change (ECR/ECO) process and maintains accountability that changes in product requirements are conveyed to the supply base, and all appropriate approvals and change control requirements have been met.

  • Support the strategic operations cost reduction initiative to deliver a minimum of 6% cost savings across a portfolio of finished product, components, and materials.

  • Develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.

  • Understand Work Flow Maturity and promote an expectation that our supply partners are driving toward maturity, with a continuous improvement mind set, to provide predictable supply that meets quality and cost targets.

  • Promote working in a data-driven environment. Set up and / or help maintain Key Performance Indicator (KPI) metrics, and participate in supplier Monthly Operations Reviews (MOR) as-required.

  • Maintain a standard for technical rigor in engineering consistent with Medtronic performance expectations, including but not limited to advanced statistics, design of experiments, hypothesis testing, variables-data distribution analysis, attribute-data success testing, sample size calculation, process capability analysis, statistical process control.

  • Promote Value Analysis/Value Engineering as a systematic process to creatively assess and generate alternatives to identify essential functions at the greatest value. Value engineering through the systematic method to improve output by using rigorous examination of function.

Must Have: Minimum Qualifications

  • Bachelor's Degree in an Engineering discipline or related technical field
  • 4+ years of experience with Bachelors Degree OR 2+ years of experience with an Advanced Degree

Nice to Have

  • Advanced Degree - M.S. or Ph.D. in Engineering, or similar relevant discipline.

  • Lean and/or Six Sigma belt certification.

  • Experience in medical device manufacturing or technology preferred.

  • Broad understanding of medical device development processes compliant with US FDA 21-CRF-820 and/or ISO 13485.

  • Demonstrated experience leading projects in engineering or program management environment.

  • Experience with process development, process characterization, process verification and validation, or component / material qualification, and acceptance testing.

  • 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.

  • Understanding of advanced structured problem-solving methodology such as Kepner-Tregoe, Kaizen, Lean Six Sigma, or other methods.

  • A self-motivated team player with excellent verbal and written communications skills. Must be able to convey business and technical concepts to diverse stake-holders and technical teams in a clear and concise manner.

  • Ability to set work direction, work independently, and communicate with a vast network of global stakeholders.

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.

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.

The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


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