Sr. Manufacturing Engineer
Sr. Manufacturing Engineer
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$ 110900 - 150000
1 Vacancy
Job Description
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.
Basic Qualifications:
Bachelors degree in Mechanical Industrial Biomedical Electronics Engineering or related engineering field and five (5) years of experience as manufacturing or quality engineer. Or Masters 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
Salary: $110900 to $150000 per year
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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:
Required Experience:
Senior IC
Employment Type
Full-Time
