Medtronic
Sr. Systems Engineer (Finance)
Position Description:
Sr. Systems Engineer for Medtronic, Inc. Minneapolis, MN. Responsible for architect next generation systems and products for diabetes therapy using a combination of Model-Based Systems Engineering (MBSE), Digital Engineering, Simulation, and System Analysis and Empirical Modeling. Responsible for system and product level design input and design output deliverables including requirements management and product design in tools such as PTC Integrity. Accountable for traceability reports including design input-to-design input and design input-to-design output. Develop and document interface designs and protocols. Support Risk Mgmt. activities and deliverables to include Use, Design and Process Failure Mode Effects Analysis (FMEA) and Product Hazard Analysis (PHA) in accordance with ISO 14971 and other applicable standards. Support design control deliverables to include product performance specification, use cases, and Use Conditions. Support technical planning for design input reviews, design freeze and verification readiness activities. Review verification and validation plan, protocol and report. Develop and assess products and systems to meet applicable internal and external standards and regulations, including IEC 60601. Support regulatory submission & Audits. Utilize DRM (Design, Reliability, and Manufacturability) methodology to suggest design/process improvement. Provide root cause analysis on product-related issues utilizing problem solving techniques and support CAPA activities. Develop comprehensive design history files using MAP Agile. This position is open to telecommuting from anywhere in the United States. #LI-DNI
Basic Qualifications:
Master's degree in Biomedical or Mechanical Engineering field or related engineering field and two (2) years of experience as a systems or reliability engineer or related occupation in systems engineering. Must possess a minimum of two (2) years' exp. with each of the following: Risk Mgmt. to include Use, Design and Process Failure Mode Effects Analysis (FMEA) and Product Hazard Analysis (PHA), ISO 14971; Design control deliverables to include product performance specification, use cases, and Use Conditions; Technical planning for design input reviews, design freeze and verification readiness activities; Verification and validation plan, protocol and reporting; IEC 60601 and supporting regulatory submission & audits; DRM (Design, Reliability, and Manufacturability) methodology; Root cause analysis, CAPA; Developing design history files, MAP Agile.
Salary: $133,400 to $157,200 per year
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: