medtronic
February 18th, 2008, 08:46 AM
It’s challenging. It’s energizing. It’s rewarding. That’s why nearly 39,000 employees around the world have chosen to spend their career at Medtronic, a global leader in medical technology. We provide lifelong solutions for people with chronic diseases guided firmly by our mission to alleviate pain, restore health and extend life. Today, every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. We hope you’ll consider joining our team and discover why Fortune magazine named us one of "America's Most Admired Companies" for the last 10 years, “100 Best Companies to Work for in America” 8 of the last 11 years, and one of the "Best Managed Companies". Medtronic has a culture of camaraderie, pride in one’s work, and trust in management.
Position Description
1) Technical Leadership:
Provide Quality technical leadership to a cross-functional team of Research Quality Engineers. The NT & D Research product portfolio is diverse and includes new concepts for hardware, software, firmware, and therapy applications. This position will be involved from early concept through feasibility assessment to provide high-quality, state-of-the-art prototypes that can be easily transitioned to a contracted development project if the feasibility assessment is favorable. This position reports to the Instruments Development and Research Reliability Manager.
2) Project Leadership:
This Quality leadership position has responsibility for guiding the NT & D Research quality strategy, quality system and quality records
Lead cross-Quality Extended Subteams throughout the product development cycle to understand product and process robustness, drive hardware quality and reliability improvements, and verify compliance with design, manufacturing, Quality System and regulatory requirements.
3) Reliability & Product Assurance Engineering:
Work in collaboration with NT & D Research Organization and other Quality partners to perform or contribute to analyses and testing to understand product and process robustness, drive hardware quality and reliability improvements, and verify compliance with design, manufacturing, Quality System and regulatory requirements.
Position Responsibilities
1) Technical Leadership responsibilities include:
a. Provide general Quality support to all NT & D Hardware Research Projects in areas of Quality Systems, Quality Assurance, Reliability Engineering, Configuration Assurance, Manufacturing Quality, Material Quality, Packaging Quality, Risk & Safety Management, and training programs appropriate for the Research environment.
b. Consult with, or delegate to, identified quality specialists. Group and individual objective setting, Resource management (work assignments, effort forecasting (PDW)),
Establish research quality procedure(s)
2) Project Leadership responsibilities include:
Develop and manage the execution of the overall NT & D Research Quality strategy for research projects, including all activities defined in item 3 below
a. Support the existing quality systems components that are effective within NT & D Research and identify & drive continuous quality improvement activities within NT & D Research.
b. Responsible for quality monitoring and reporting for NT & D. This includes defining, measuring, and reporting metrics and business performance scorecards, issues reporting and other performance measures.
c. Ensure NT & D Research systems are compliant to CRDM and Corporate requirements as well as to QSR, ISO, GCP and other global regulations.
d. Ensure overall success of the Research Quality Extended Subteam
e. Lead issue resolution efforts related to Research Quality Extended Subteam activites
f. Contribute to overall project schedule development, maintain Research Quality aspects of project schedules, and assure timely completion of required activities
3) Reliability & Product Assurance Engineering responsibilities include:
a. Design Assurance: Provide design input, contribute to design controls, evaluate field product performance data, work with Regulatory Affairs to determine compliance requirements, establish project quality and reliability goals and metrics to drive continuous improvement.
b. Reliability Engineering: Develop and execute package testing, facilitate risk management, hazard analysis discussions, and other reliability assessments. Lead standards update implementation into the organization. Write qualification test plans and coordinate the testing. Assure resolution/mitigation, corrective action and preventive action for all issues raised during testing. Provide input for Regulatory submissions.
c. Configuration Assurance: Promote adherence to procedures and plans, conduct Design History File audits, ensure documentation is available for clinical release.
d. Manufacturing Quality Assurance: Monitor manufacturing quality, implement corrective and preventive action as appropriate, ensure completeness of build traceability.
e. Material Quality Assurance: Establish component specifications, when appropriate, ensure suppliers are compliant with specifications and other requirements, review component changes and substitutions,
Basic Qualifications
1) BS in engineering or related technical field (e.g., physics, material science, etc.)
2) Minimum 12 years of experience in a technical discipline (10 years with a Masters in a Technical discipline; 6 years with a PhD in a technical discipline)
3) Minimum 3 years of experience in Reliability, Design Assurance, or Product Assurance engineering
4) Minimum 2 years experience leading cross-functional teams and managing projects (minimum of 2 projects) involving multiple tasks
5) Experience using word processing, spreadsheets, and project management tools
Desired/Preferred Qualifications
1) Demonstrated influence management skills
2) Well-developed written and oral skills (work samples and oral presentation requested)
3) Work experience in all Quality disciplines (Material, Manufacturing, Design/Reliability, Post-Market Surveillance, Quality Systems, Configuration Assurance, Quality Control)
4) Working knowledge of statistical techniques and quality/reliability tools (FMEA, FTA, HALT, DOE, SPC, etc.)
5) Proficient in data analysis with experience using issue analysis/problem solving tools (Root Cause Analysis, 8-D, etc.)
6) Experience with new product development/product realization
7) Experience in a regulated industry and knowledge of regulatory requirements/submissions
8) Ability to support several projects simultaneously while effectively adapting to changing project parameters
9) Fluent in English language
10) Experience managing people
Physical Job Requirements
1) Mobility Requirements: Stand/Sit/Walk 8 hrs/day; ability to travel across campus and between facilities.
2) Dexterity Requirements: Able to use computer & monitor to develop, review and communicate job-related documentation.
3) Vision requirements: Correctable to 20/20 in 1 eye and 20/40 in other eye. Able to use computer & monitor to develop, review and communicate job-related documentation.
4) Hearing requirements: Able to participate in meetings and conference calls and to use a telephone.
TO APPLY: Submit your resume at www.medtronic.com/employment (outbind://2/www.medtronic.com/employment). Click Job Opportunities, U.S. & Puerto Rico, click Search by Req ID, Enter Requisition:60875, review job description and select "Apply Now" to route your resume directly to the hiring department. No agencies or phone calls, please.
Position Description
1) Technical Leadership:
Provide Quality technical leadership to a cross-functional team of Research Quality Engineers. The NT & D Research product portfolio is diverse and includes new concepts for hardware, software, firmware, and therapy applications. This position will be involved from early concept through feasibility assessment to provide high-quality, state-of-the-art prototypes that can be easily transitioned to a contracted development project if the feasibility assessment is favorable. This position reports to the Instruments Development and Research Reliability Manager.
2) Project Leadership:
This Quality leadership position has responsibility for guiding the NT & D Research quality strategy, quality system and quality records
Lead cross-Quality Extended Subteams throughout the product development cycle to understand product and process robustness, drive hardware quality and reliability improvements, and verify compliance with design, manufacturing, Quality System and regulatory requirements.
3) Reliability & Product Assurance Engineering:
Work in collaboration with NT & D Research Organization and other Quality partners to perform or contribute to analyses and testing to understand product and process robustness, drive hardware quality and reliability improvements, and verify compliance with design, manufacturing, Quality System and regulatory requirements.
Position Responsibilities
1) Technical Leadership responsibilities include:
a. Provide general Quality support to all NT & D Hardware Research Projects in areas of Quality Systems, Quality Assurance, Reliability Engineering, Configuration Assurance, Manufacturing Quality, Material Quality, Packaging Quality, Risk & Safety Management, and training programs appropriate for the Research environment.
b. Consult with, or delegate to, identified quality specialists. Group and individual objective setting, Resource management (work assignments, effort forecasting (PDW)),
Establish research quality procedure(s)
2) Project Leadership responsibilities include:
Develop and manage the execution of the overall NT & D Research Quality strategy for research projects, including all activities defined in item 3 below
a. Support the existing quality systems components that are effective within NT & D Research and identify & drive continuous quality improvement activities within NT & D Research.
b. Responsible for quality monitoring and reporting for NT & D. This includes defining, measuring, and reporting metrics and business performance scorecards, issues reporting and other performance measures.
c. Ensure NT & D Research systems are compliant to CRDM and Corporate requirements as well as to QSR, ISO, GCP and other global regulations.
d. Ensure overall success of the Research Quality Extended Subteam
e. Lead issue resolution efforts related to Research Quality Extended Subteam activites
f. Contribute to overall project schedule development, maintain Research Quality aspects of project schedules, and assure timely completion of required activities
3) Reliability & Product Assurance Engineering responsibilities include:
a. Design Assurance: Provide design input, contribute to design controls, evaluate field product performance data, work with Regulatory Affairs to determine compliance requirements, establish project quality and reliability goals and metrics to drive continuous improvement.
b. Reliability Engineering: Develop and execute package testing, facilitate risk management, hazard analysis discussions, and other reliability assessments. Lead standards update implementation into the organization. Write qualification test plans and coordinate the testing. Assure resolution/mitigation, corrective action and preventive action for all issues raised during testing. Provide input for Regulatory submissions.
c. Configuration Assurance: Promote adherence to procedures and plans, conduct Design History File audits, ensure documentation is available for clinical release.
d. Manufacturing Quality Assurance: Monitor manufacturing quality, implement corrective and preventive action as appropriate, ensure completeness of build traceability.
e. Material Quality Assurance: Establish component specifications, when appropriate, ensure suppliers are compliant with specifications and other requirements, review component changes and substitutions,
Basic Qualifications
1) BS in engineering or related technical field (e.g., physics, material science, etc.)
2) Minimum 12 years of experience in a technical discipline (10 years with a Masters in a Technical discipline; 6 years with a PhD in a technical discipline)
3) Minimum 3 years of experience in Reliability, Design Assurance, or Product Assurance engineering
4) Minimum 2 years experience leading cross-functional teams and managing projects (minimum of 2 projects) involving multiple tasks
5) Experience using word processing, spreadsheets, and project management tools
Desired/Preferred Qualifications
1) Demonstrated influence management skills
2) Well-developed written and oral skills (work samples and oral presentation requested)
3) Work experience in all Quality disciplines (Material, Manufacturing, Design/Reliability, Post-Market Surveillance, Quality Systems, Configuration Assurance, Quality Control)
4) Working knowledge of statistical techniques and quality/reliability tools (FMEA, FTA, HALT, DOE, SPC, etc.)
5) Proficient in data analysis with experience using issue analysis/problem solving tools (Root Cause Analysis, 8-D, etc.)
6) Experience with new product development/product realization
7) Experience in a regulated industry and knowledge of regulatory requirements/submissions
8) Ability to support several projects simultaneously while effectively adapting to changing project parameters
9) Fluent in English language
10) Experience managing people
Physical Job Requirements
1) Mobility Requirements: Stand/Sit/Walk 8 hrs/day; ability to travel across campus and between facilities.
2) Dexterity Requirements: Able to use computer & monitor to develop, review and communicate job-related documentation.
3) Vision requirements: Correctable to 20/20 in 1 eye and 20/40 in other eye. Able to use computer & monitor to develop, review and communicate job-related documentation.
4) Hearing requirements: Able to participate in meetings and conference calls and to use a telephone.
TO APPLY: Submit your resume at www.medtronic.com/employment (outbind://2/www.medtronic.com/employment). Click Job Opportunities, U.S. & Puerto Rico, click Search by Req ID, Enter Requisition:60875, review job description and select "Apply Now" to route your resume directly to the hiring department. No agencies or phone calls, please.