Sr. Manufacturing Engineer
Medtronic
111k - 150k USD/year
Office
WI Milwaukee, United States
Full Time
Position Description:
Sr. Manufacturing Engineer for Medtronic, Inc. located in Milwaukee, WI. Responsible for improving manufacturing processes, optimize product performance and reduce manufacturing costs. Provide manufacturing floor support and coordinate implementation of manufacturing improvements to assigned product lines. Assist with daily production and development of Class I, Class II and Class III Medical Devices by supporting machining, packaging, warehousing, and inventory control. Responsible for cleaning validations per ISO 10993 to ensure new medical devices or manufacturing changes meet biocompatibility requirements of cytotoxicity and endotoxin tests. Utilize Six Sigma tools including Good Manufacturing Practices (GMP), 5S, 6M, 5-Whys, DMAIC & Kaizen to drive process efficiency and reduce cost in the manufacturing process. Develop protocols for Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Gage R&R and Test Method Validations (TMV). Implement and validate new manufacturing processes including laser marking, passivation and anodization. Conduct studies pertaining to cost control, waste reduction and inventory control and production record systems using Agile MAP. Coordinate investigation of Non-Conformances (NCs) and Corrective and Preventative Actions (CAPA) Investigations to control non confirming product and mitigate process risks or deviations that will impact patients. Navigate various engineering principles within an FDA regulated environment (FDA 21 CFR Part 820) and follow ISO-13485 and ISO 9001. Provide Design for DRM (Design, Reliability, and Manufacturing) practices and tools using Solid works or Unigraphics modeling software. Leverage knowledge from being a certified Lean Sigma Yellow belt or higher. Relocation assistance not provided. #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 in Mechanical, Industrial, Biomedical, Electronics Engineering or related engineering field and five (5) years of experience as manufacturing or quality engineer. Or, Master’s degree in Mechanical, Industrial, Biomedical, Electronics Engineering or related engineering field and two (2) years of experience as manufacturing or quality engineer. Must possess at least two (2) years’ experience with each of the following: Manufacturing in medical device industry including Class I, Class II and Class III devices; Cleaning validations per ISO 10993 & Cytotoxicity and Endotoxin testing; Six Sigma methodologies including GMP, 5S, 6M, 5-Whys, DMAIC, & Kaizen; IQ/OQ/PQ, TMV, & Gage R&R; Laser marking technology, Passivation, and Anodizing process; Coordinating studies for cost control, waste reduction and inventory control; NC & CAPA Investigations; Medical Device Quality & Regulatory Compliance (FDA 21 CFR Part 820, ISO 13485, and ISO 9001). DRM practices and tools using Solid works or Unigraphics modeling software.
The following certification is required: Lean Six Sigma Yellow Belt or higher
The position is located at Medtronic, Inc., 8347 N. Steven Road, Milwaukee, WI 53223.
Salary: $110,900 to $150,000 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.
Further details are available at the link below:
https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic
Sr. Manufacturing Engineer for Medtronic, Inc. located in Milwaukee, WI. Responsible for improving manufacturing processes, optimize product performance and reduce manufacturing costs. Provide manufacturing floor support and coordinate implementation of manufacturing improvements to assigned product lines. Assist with daily production and development of Class I, Class II and Class III Medical Devices by supporting machining, packaging, warehousing, and inventory control. Responsible for cleaning validations per ISO 10993 to ensure new medical devices or manufacturing changes meet biocompatibility requirements of cytotoxicity and endotoxin tests. Utilize Six Sigma tools including Good Manufacturing Practices (GMP), 5S, 6M, 5-Whys, DMAIC & Kaizen to drive process efficiency and reduce cost in the manufacturing process. Develop protocols for Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Gage R&R and Test Method Validations (TMV). Implement and validate new manufacturing processes including laser marking, passivation and anodization. Conduct studies pertaining to cost control, waste reduction and inventory control and production record systems using Agile MAP. Coordinate investigation of Non-Conformances (NCs) and Corrective and Preventative Actions (CAPA) Investigations to control non confirming product and mitigate process risks or deviations that will impact patients. Navigate various engineering principles within an FDA regulated environment (FDA 21 CFR Part 820) and follow ISO-13485 and ISO 9001. Provide Design for DRM (Design, Reliability, and Manufacturing) practices and tools using Solid works or Unigraphics modeling software. Leverage knowledge from being a certified Lean Sigma Yellow belt or higher. Relocation assistance not provided. #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 in Mechanical, Industrial, Biomedical, Electronics Engineering or related engineering field and five (5) years of experience as manufacturing or quality engineer. Or, Master’s degree in Mechanical, Industrial, Biomedical, Electronics Engineering or related engineering field and two (2) years of experience as manufacturing or quality engineer. Must possess at least two (2) years’ experience with each of the following: Manufacturing in medical device industry including Class I, Class II and Class III devices; Cleaning validations per ISO 10993 & Cytotoxicity and Endotoxin testing; Six Sigma methodologies including GMP, 5S, 6M, 5-Whys, DMAIC, & Kaizen; IQ/OQ/PQ, TMV, & Gage R&R; Laser marking technology, Passivation, and Anodizing process; Coordinating studies for cost control, waste reduction and inventory control; NC & CAPA Investigations; Medical Device Quality & Regulatory Compliance (FDA 21 CFR Part 820, ISO 13485, and ISO 9001). DRM practices and tools using Solid works or Unigraphics modeling software.
The following certification is required: Lean Six Sigma Yellow Belt or higher
The position is located at Medtronic, Inc., 8347 N. Steven Road, Milwaukee, WI 53223.
Salary: $110,900 to $150,000 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.
Further details are available at the link below:
https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic
Sr. Manufacturing Engineer
Office
WI Milwaukee, United States
Full Time
111k - 150k USD/year
August 18, 2025