Senior Sourcing Engineer

Position Description:

Sr. Sourcing Engineer for Covidien LP (a Medtronic company) located in Lafayette CO. Provide technical engineering expertise and serve as the technical liaison between Medtronic design requirements and suppliers technical capability to support business objectives; facilitate Lean-Sigma continuous improvement with suppliers support and implementation; identify risks associated with low margins between supplier processes and design requirements; understand and conform with medical device industry standards and regulatory requirements to include Food and Drug Administration (FDA) regulations ISO 13485 ISOCFR Part 820 IEC 60601 Corrective Action & Preventive Action (CAPA) and GMP (Good Manufacturing Practices); execute lean transformation projects product transfers cost savings and material replacement projects with suppliers; coordinate and drive continuous improvement activities including process characterizations and optimization using methodologies including Design of Experiments (DOE) Time studies value analysis and value engineering (VAVE) DRM (Design Reliability and Manufacturability) and Lean Six Sigma; facilitate selection of new suppliers ensuring Medtronic design requirements are met; coordinate root cause investigations of product or process non-conformances using six sigma methodology; establish process flows coordinate process validations using Installation Qualification Operational Qualification and Performance Qualification (IQ/OQ/PQ) protocols; oversee statistical analysis by using techniques including Gage R and R ANOVA variables data distribution sample size calculation statistical process control and Capability and Normality Assessments; oversee and coordinate Critical Feature Identification (CFI) Critical to Quality (CTQ) determination Process Failure Mode and Effect Analysis (PFMEA) and Design Failure Mode and Effect Analysis (DFMEA) activities; and coordinate inspection methods including variables and attribute.

Position works a hybrid model and will be onsite in Lafayette CO 4 days per week.

Basic Qualifications:

Bachelors Degree in Electrical Mechanical or Biomedical Engineering or related engineering field and four (4) years as a supplier electrical or quality engineer or related occupation in supplier quality engineering for medical devices. Must possess at least four (4) years experience with each of the following: FDA regulations 21 CFR Part 820 ISO 13485 ISO 14971 IEC 60601 CAPA and GMP; Lean transformation projects product transfers cost savings and material replacement projects; Process characterizations and optimization using methodologies including DOE Time studies VAVE and Lean Six Sigma; Identifying root cause of product or process non-conformances; Establishing process flows and conducting process validations using IQ/OQ/PQ; Gage R &R ANOVA variables data distribution sample size calculation statistical process control and Normality Assessments; CFI PFMEA DFMEA and CTQ; Coordinating inspection methods including variables and attribute.

Salary: $113400 to $156000 per year

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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: Medtronic benefits and compensation plans