Key skills
CRERPResource PlanningProblem Solving
About this role
Position Description:
Responsible for driving operational excellence by ensuring the successful design, development, deployment, operation, and optimization of the Manufacturing Execution System (MES). Conduct various studies pertaining to cost reduction, Return on Investment (ROI), inventory control and production record systems. Define Manufacturing Execution System (MES) architecture, configuration, and implementation of MES workflows to support production operations and regulatory traceability. Define Standard Operating Procedure (SOP) and data models linking MES with ERP (Enterprise Resource Planning) and other Manufacturing and quality systems within the manufacturing environment. Comply with Medical industry standards system testing and validation according to Good Manufacturing Practices (GMP), 21 CFR Part 11 requirements, regulations and quality mgmt. requirements by conducting audits and implementing controls to ensure regulatory compliance. Monitor performance of the MES system to ensure efficiency by analyzing system metrics, identifying areas for optimization and implementing system enhancements. Apply DMAIC (Design, Measure, Analyze, Improve, and Control) problem solving methodologies. Develop and maintain digital manufacturing documentation, including work instructions and process maps, within the MES framework. Conduct Installation Qualification, Operational Qualification, and Performance Qualification (IQ/OQ/PQ) system validation protocols involving test steps per production line to ensure MES compliance with regulations. Relocation assistance not available for this position. #LI-DNI.
NOTICE: Pursuant to 20 C.F.R. § 656.10, you are hereby notified that an Application for Permanent Employment Certification will be filed for the job opportunity below. Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer at the U.S. Department of Labor as follows:
Certifying Officer
U.S. Department of Labor
Employment and Training Administration
Office of Foreign Labor Certification
200 Constitution Avenue NW, Room N-5311
Washington, DC 20210
Basic Qualifications:
Bachelor’s Degree or foreign equivalent in Electronic Engineering, Electronics & Instrumentation, Mechanical Engineering, or related engineering field and five (5) years of progressively responsible experience as a systems engineer, electronics engineer, or mechanical engineer. Must possess at least 5 years’ experience with each of the following: Conducting studies pertaining to cost reduction, ROI, inventory control and production record systems; MES architecture, defining workflows, configuring user interfaces, and integrating with ERP; Conducting Testing, Validation and implementing controls for regulatory compliance; Monitoring, optimizing, and implementing enhancements of MES systems; DMAIC; Developing and maintaining Digital manufacturing Documentation; and Conducting IQ/OQ/PQ system validation protocols involving test steps per production line for MES compliance with regulations.
The position is located at Medtronic, Inc., 35 Cherry Hill Drive, Danvers, MA 01923.
Salary: $148,000 to $184,800 per year
THIS POSITION QUALIFIES FOR THE MEDTRONIC EMPLOYEE REFERRAL BONUS PROGRAM AT THE LEVEL OF $1,000. Refer to the program guidelines located at InternalJobs.Medtronic.com.
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Use this link to hyperlink
https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic
Responsible for driving operational excellence by ensuring the successful design, development, deployment, operation, and optimization of the Manufacturing Execution System (MES). Conduct various studies pertaining to cost reduction, Return on Investment (ROI), inventory control and production record systems. Define Manufacturing Execution System (MES) architecture, configuration, and implementation of MES workflows to support production operations and regulatory traceability. Define Standard Operating Procedure (SOP) and data models linking MES with ERP (Enterprise Resource Planning) and other Manufacturing and quality systems within the manufacturing environment. Comply with Medical industry standards system testing and validation according to Good Manufacturing Practices (GMP), 21 CFR Part 11 requirements, regulations and quality mgmt. requirements by conducting audits and implementing controls to ensure regulatory compliance. Monitor performance of the MES system to ensure efficiency by analyzing system metrics, identifying areas for optimization and implementing system enhancements. Apply DMAIC (Design, Measure, Analyze, Improve, and Control) problem solving methodologies. Develop and maintain digital manufacturing documentation, including work instructions and process maps, within the MES framework. Conduct Installation Qualification, Operational Qualification, and Performance Qualification (IQ/OQ/PQ) system validation protocols involving test steps per production line to ensure MES compliance with regulations. Relocation assistance not available for this position. #LI-DNI.
NOTICE: Pursuant to 20 C.F.R. § 656.10, you are hereby notified that an Application for Permanent Employment Certification will be filed for the job opportunity below. Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer at the U.S. Department of Labor as follows:
Certifying Officer
U.S. Department of Labor
Employment and Training Administration
Office of Foreign Labor Certification
200 Constitution Avenue NW, Room N-5311
Washington, DC 20210
Basic Qualifications:
Bachelor’s Degree or foreign equivalent in Electronic Engineering, Electronics & Instrumentation, Mechanical Engineering, or related engineering field and five (5) years of progressively responsible experience as a systems engineer, electronics engineer, or mechanical engineer. Must possess at least 5 years’ experience with each of the following: Conducting studies pertaining to cost reduction, ROI, inventory control and production record systems; MES architecture, defining workflows, configuring user interfaces, and integrating with ERP; Conducting Testing, Validation and implementing controls for regulatory compliance; Monitoring, optimizing, and implementing enhancements of MES systems; DMAIC; Developing and maintaining Digital manufacturing Documentation; and Conducting IQ/OQ/PQ system validation protocols involving test steps per production line for MES compliance with regulations.
The position is located at Medtronic, Inc., 35 Cherry Hill Drive, Danvers, MA 01923.
Salary: $148,000 to $184,800 per year
THIS POSITION QUALIFIES FOR THE MEDTRONIC EMPLOYEE REFERRAL BONUS PROGRAM AT THE LEVEL OF $1,000. Refer to the program guidelines located at InternalJobs.Medtronic.com.
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Use this link to hyperlink
https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic