What are the responsibilities and job description for the Principal Manufacturing Engineer position at Medtronic?
**Careers that Change Lives**
We are looking for a Principal Manufacturing Engineering professional who is proficient in complex electromechanical manufacturing processes engineering and who excels in leadership behaviors and is looking to stand out and demonstrate their leadership and technical abilities in a highly visible role in our Global Contract Manufacturing team.
The Principal Manufacturing Engineer primary responsibilities are reactive, urgent, line down support and issue resolution and proactive improvements at our external partners manufacturing processes. This includes but is not limited to, day to day operations engineering support and engineering project leadership related to Medtronic Finished Good products and processes at Contract Manufacturing (CM) sites. This may also include leading x-functional sustaining teams and programs, leading and supporting strategic activities in relation to NPI, BD&L and Line Transfers, drive Engineering & Quality excellence programs with the CM's and OEM's, and identify and deliver cost down solutions and process improvements.
The Principal Manufacturing Engineer will collaborate with Operations & OU Quality, Released Product Engineering, Supply Planning, Supply Management, and the CM/OEM's to ensure quality excellence, continuity of supply and execution of all identified project objectives in a dynamic environment.
The role will have a global view and influence which will require engagement with stakeholders in the internal and external functions around the globe. Therefore, there will be an expectation to travel as required (up to 50%) to support specific initiatives and programs, and to engage with stakeholders during hours which are required to manage across global time-zones. This role can be remote or based out of any Medtronic site.
The ideal candidate will be US or Mexico based, with standout leadership behaviors and will have an expert understanding of a variety of manufacturing processes. You will have a demonstrated track record of driving tangible process improvements, leading teams and using structured problem solving and your expert understanding of process improvement techniques such as LEAN, Demand Flow, 6 sigma, etc. As a seasoned engineer, you will be expected to work independently yet collaboratively, coach and review lower level and peer work, understand multiple issues and specialties, communicate expertly with internal and external partners, and manage projects of major/moderate complexity.
**A Day in the Life**
Responsibilities may include the following and other duties may be assigned.
Main technical point of contact for external contract manufacturing partners
Consistently deliver proactive, high-quality manufacturing technical support and guidance to Contract Manufacturers for engineering issues.
Designs, sustains and improves manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling
Evaluate and feedback to development on contract manufacturability and integration of new product introductions and transfers
Manage change orders affecting product and process for implementation at our contract manufacturers
Manage BOM's and DMR for sustaining manufacturing
Resolve emergent technical issues, provide troubleshooting, failure (root cause) analysis and provide permanent solutions
Responsible for on time product delivery, quality and cost
Initiate and execute continuous improvement activities to improve product quality, reduce manufacturing costs, and reduce manufacturing process cycle time
Establish process and equipment performance metrics, monitoring performance trends, and maintaining and improving manufacturing efficiency.
Participate in product design review and ensure design for manufacturability and all requirement specifications are met
Ensures processes and procedures are in compliance with regulations
Sustain contract manufacturing processes, testers, fixtures, and equipment
Participate in vendor and supplier selection and qualification process to ensure they meet company's quality standards, technical requirements, and supply demand
Participate as SME in FDA inspections, ISO Certifications and internal and external customer audits.
Conduct, coordinate, and provide support in formal Process Validations including protocol development and execution.
Manage all technical aspects of the Change Management processes into the Contract Manufacturing organization.
Provide inputs to the MDT Supplier Change Request ( SCR ) Board process and own assigned SCR's
Provide Engineering input to all capacity planning activities
Specify, procure, and manage capital in the support of manufacturing and test processes.
Support the development of multi-year capital procurement plans
Provide guidance to Contract Manufacturer in designs and evaluate new and existing fixtures and equipment, test methods, specifications, layouts, and standards supporting a Lean manufacturing environment.
Work as a liaison with the Contract Manufacturer and MDT to ensure Design for Manufacturing (DFM) elements are incorporated to improve yield and reduce costs.
Ensure adherence to product specifications, industry standards, and quality and regulatory procedures and requirements.
Manage technical aspects of product and process at Contract Manufacturing & OEM partners.
Provide technical support and guidance to colleagues and peers in RPE, R&D and other functions about working with CM and OEM partners.
Lead and support Quality and Engineering initiatives at CM's
Develop and execute cost down plans in collaboration with the CM's
Support NPI and BD&L programs as required
**Must Have: Minimum Requirements**
Bachelors degree required
Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
**Nice to Have**
Electrical engineering degree or relevant experience with complex electromechanical products, test systems and solutions - ability to interact and partner with electrical and system design engineers
10 years of Manufacturing Engineering experience or equivalent
5 years of experience working in a regulated industry
Experience with Contract Manufacturing (preferred but not mandatory)
Familiarity with SPC, Experimental Design, and Statistical Sampling Techniques.
Detailed understanding of Change Management Processes and Procedures. Experience with Agile PLM an advantage
Process Verification and Validation knowledge
Lean manufacturing/Demand Flow, COS/MOS, TPS and Shingo concepts and understanding
Proven use of structured problems solving and ability to teach others
Project Management Qualification or Training
Experience leading global project teams and operating effectively in a virtual workspace
Experience with operations processes including supply planning, capacity planning, sourcing
Demonstrated understanding and application of financial planning and analysis
Clear communicator with excellent written and verbal presentation skills
Ability to understand and operate within a complex, global matrixed organization
Proven track-record of successful influence without authority where both collaboration and persuasion of cross-functional stakeholders was critical
Demonstrated ability to interact and collaborate with all levels of the organization and external stakeholders including Contract Manufacturers
Ability to deal with ambiguity and pivot quickly to meet changing business priorities
Self-directed with the ability to develop, facilitate and gain consensus in a team environment
Strong analytical and data driven approach
Working knowledge of global Quality System requirements, Medical Device manufacturing, knowledge of ISO 13485/FDA requirements
Demonstrate flexibility, adaptability and integrity when making decisions, adopting a risk-based approach
Travel may be required up to 50%
**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 physical demands described within the Responsibilities 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
Min Salary
108400
Max Salary
162600
We are looking for a Principal Manufacturing Engineering professional who is proficient in complex electromechanical manufacturing processes engineering and who excels in leadership behaviors and is looking to stand out and demonstrate their leadership and technical abilities in a highly visible role in our Global Contract Manufacturing team.
The Principal Manufacturing Engineer primary responsibilities are reactive, urgent, line down support and issue resolution and proactive improvements at our external partners manufacturing processes. This includes but is not limited to, day to day operations engineering support and engineering project leadership related to Medtronic Finished Good products and processes at Contract Manufacturing (CM) sites. This may also include leading x-functional sustaining teams and programs, leading and supporting strategic activities in relation to NPI, BD&L and Line Transfers, drive Engineering & Quality excellence programs with the CM's and OEM's, and identify and deliver cost down solutions and process improvements.
The Principal Manufacturing Engineer will collaborate with Operations & OU Quality, Released Product Engineering, Supply Planning, Supply Management, and the CM/OEM's to ensure quality excellence, continuity of supply and execution of all identified project objectives in a dynamic environment.
The role will have a global view and influence which will require engagement with stakeholders in the internal and external functions around the globe. Therefore, there will be an expectation to travel as required (up to 50%) to support specific initiatives and programs, and to engage with stakeholders during hours which are required to manage across global time-zones. This role can be remote or based out of any Medtronic site.
The ideal candidate will be US or Mexico based, with standout leadership behaviors and will have an expert understanding of a variety of manufacturing processes. You will have a demonstrated track record of driving tangible process improvements, leading teams and using structured problem solving and your expert understanding of process improvement techniques such as LEAN, Demand Flow, 6 sigma, etc. As a seasoned engineer, you will be expected to work independently yet collaboratively, coach and review lower level and peer work, understand multiple issues and specialties, communicate expertly with internal and external partners, and manage projects of major/moderate complexity.
**A Day in the Life**
Responsibilities may include the following and other duties may be assigned.
Main technical point of contact for external contract manufacturing partners
Consistently deliver proactive, high-quality manufacturing technical support and guidance to Contract Manufacturers for engineering issues.
Designs, sustains and improves manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling
Evaluate and feedback to development on contract manufacturability and integration of new product introductions and transfers
Manage change orders affecting product and process for implementation at our contract manufacturers
Manage BOM's and DMR for sustaining manufacturing
Resolve emergent technical issues, provide troubleshooting, failure (root cause) analysis and provide permanent solutions
Responsible for on time product delivery, quality and cost
Initiate and execute continuous improvement activities to improve product quality, reduce manufacturing costs, and reduce manufacturing process cycle time
Establish process and equipment performance metrics, monitoring performance trends, and maintaining and improving manufacturing efficiency.
Participate in product design review and ensure design for manufacturability and all requirement specifications are met
Ensures processes and procedures are in compliance with regulations
Sustain contract manufacturing processes, testers, fixtures, and equipment
Participate in vendor and supplier selection and qualification process to ensure they meet company's quality standards, technical requirements, and supply demand
Participate as SME in FDA inspections, ISO Certifications and internal and external customer audits.
Conduct, coordinate, and provide support in formal Process Validations including protocol development and execution.
Manage all technical aspects of the Change Management processes into the Contract Manufacturing organization.
Provide inputs to the MDT Supplier Change Request ( SCR ) Board process and own assigned SCR's
Provide Engineering input to all capacity planning activities
Specify, procure, and manage capital in the support of manufacturing and test processes.
Support the development of multi-year capital procurement plans
Provide guidance to Contract Manufacturer in designs and evaluate new and existing fixtures and equipment, test methods, specifications, layouts, and standards supporting a Lean manufacturing environment.
Work as a liaison with the Contract Manufacturer and MDT to ensure Design for Manufacturing (DFM) elements are incorporated to improve yield and reduce costs.
Ensure adherence to product specifications, industry standards, and quality and regulatory procedures and requirements.
Manage technical aspects of product and process at Contract Manufacturing & OEM partners.
Provide technical support and guidance to colleagues and peers in RPE, R&D and other functions about working with CM and OEM partners.
Lead and support Quality and Engineering initiatives at CM's
Develop and execute cost down plans in collaboration with the CM's
Support NPI and BD&L programs as required
**Must Have: Minimum Requirements**
Bachelors degree required
Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
**Nice to Have**
Electrical engineering degree or relevant experience with complex electromechanical products, test systems and solutions - ability to interact and partner with electrical and system design engineers
10 years of Manufacturing Engineering experience or equivalent
5 years of experience working in a regulated industry
Experience with Contract Manufacturing (preferred but not mandatory)
Familiarity with SPC, Experimental Design, and Statistical Sampling Techniques.
Detailed understanding of Change Management Processes and Procedures. Experience with Agile PLM an advantage
Process Verification and Validation knowledge
Lean manufacturing/Demand Flow, COS/MOS, TPS and Shingo concepts and understanding
Proven use of structured problems solving and ability to teach others
Project Management Qualification or Training
Experience leading global project teams and operating effectively in a virtual workspace
Experience with operations processes including supply planning, capacity planning, sourcing
Demonstrated understanding and application of financial planning and analysis
Clear communicator with excellent written and verbal presentation skills
Ability to understand and operate within a complex, global matrixed organization
Proven track-record of successful influence without authority where both collaboration and persuasion of cross-functional stakeholders was critical
Demonstrated ability to interact and collaborate with all levels of the organization and external stakeholders including Contract Manufacturers
Ability to deal with ambiguity and pivot quickly to meet changing business priorities
Self-directed with the ability to develop, facilitate and gain consensus in a team environment
Strong analytical and data driven approach
Working knowledge of global Quality System requirements, Medical Device manufacturing, knowledge of ISO 13485/FDA requirements
Demonstrate flexibility, adaptability and integrity when making decisions, adopting a risk-based approach
Travel may be required up to 50%
**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 physical demands described within the Responsibilities 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
Min Salary
108400
Max Salary
162600
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