
Website Medtronic
Job Description:
In this exciting role as a Global UNiD Quality, Process, and Training Engineer you will have responsibility for working collaboratively with the Global UNiD management team to 1. develop a systematic training process for the global UNiD lab team, 2. development of deep technical expertise and knowledge of factors affecting spine quality, planning variability, and objective quality, 3. ongoing documentation and updating of standard operating procedures focused on the surgical planning process, 4. R&D projects focused on surgical planning, optimization of workflow, quality, and process redesign. This role is critical as we grow and scales this business across the full cranial and spinal technologies business globally.
Job Responsibilities:
- Collaborate with surgeons, subject matter experts (SMEs) and data scientists to integrate new learning and expert opinion into case planning
- Collaborate with senior lab personnel to define quality objectives and definitions of plan success
- Lead the quality monitoring program for case planning deliverables and data
- Harmonize the US/French planning and QA processes
- Lead quality-critical documentation initiatives
- Manage HUB training for new releases
- Lead the change management process for supporting the release of new planning parameters and guidance
- Maintain and expand the advanced training program for consultants, US and OUS Lab
- Collaborate with the HUB development team on R&D initiatives related to measurements, planning, and surgical preferences
- Manage the continuous improvement program for case measurement and planning, including ongoing standardization initiatives
Job Requirements:
- Lean Six Sigma green/black belt
- Strong technical understanding.
- Working knowledge of process improvement skills.
- Ability to effectively solve problems.
- Certified Quality Engineer (CQE) or other similar Quality/Reliability certifications
- Fluent in English or French are beneficial as well
- Ability to work effectively in a team environment with a diverse group of people.
- Strong knowledge in CAPA, NCMR, RMA, Labeling, Rework and Batch release processes.
- Ability to engage in change management processes, communicate changes with team, and influence change management across a broad stakeholder group.
Qualification & Experience:
- Experience in utilization of statistical techniques such design of experiments, hypothesis testing, SPC, etc. as part of Quality Engineering discipline.
- Bachelors degree required
- Experience running a training program
- Experience leading a quality monitoring
- Experience working with outside consultants and cross functional teams
- Experience with medical device design for reliability tools and modeling.
- Mechanical Design Experience
- Experience in the development of standard operating procedures
- Experience managing the continuous improvement programs
- Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
- UNiD lab or consulting experience
- Experience working with complex spinal procedures.
- Experience with surgeon engagement.
Job Details:
Company: Medtronic
Vacancy Type: Full Time
Job Location: South Bend, IN, US
Application Deadline: N/A
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