Change Management Engineer
Portage, MI
Stryker is seeking to hire a Change Management Engineer to Orthopedic Instruments and the Shared Service Change Management Team within Stryker Instruments.
Work Flexibility: Hybrid.
This role requires reasonable proximity to our Stryker facility. You should be comfortable working 3 days onsite.
Who we want:
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
- Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
- Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Curious learners. Individuals who seek out practical methods and information to expand and enhance their ability.
What you will do:
As a Change Management Engineer, you will manage and execute complex Engineering Change Notices (ECNs) in our PLM System for Orthopedic Instruments to support various business and engineering activities.
You will also:
- Create complex changes within the PLM System to ensure data, documents, content and information submitted in the change is accurate and compliant.
- Collaborates with the necessary stakeholders as needed to build, complete and monitor the Implementation Plan as well as the ECN.
- Facilitate and organize the Change Implementation Board (CIB) when required.
- Act as a subject matter expert in the Change Management/Change Control process as well as the onePLM system.
- Responsible for following the Change Management/Change Control process and procedures effectively within our Quality System.
- Collaborate with stakeholders across several business functions providing excellent customer service while creating and routing complex changes in our Quality System.
- Collaborate with relevant functional groups to mentor and coach teams and stakeholders through the change control process and the workflow within onePLM.
- Under minimal supervision, works with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management to ensure project success.
- May act as the Change Owner as well as the Change Analyst II on changes.
- Additional projects related to the Change Management Engineer role as needed.
- May support and participate in audits.
- Identifies complex PLM/CAII problems, applying engineering experience and learnings for improvements and risk mitigation.
What you will need:
Required:
- Bachelor of Science in Engineering, Mechanical Engineering, Biomedical Engineering, or in a related engineering discipline.
- PLM Knowledge.
Preferred:
- Experience in quality and/or engineering
- Experience with New Product Development
- Experience working Engineer, Designer, Project Manager.
- Experience in the Medical Device Industry.
- Windchill, OnePLM, Teamcenter, or other PLM experience.
- General understanding of basic engineering principles
- Must possess attention to detail.
- The ability to understand the products and processes involved in the change.
- Must possess strong communication, project management and influencing skills as well as successfully manage multiple tasks simultaneously.
- The ability to problem-solve complex situations by filtering, prioritizing, and analyzing complex and dynamic material.
More Information
Application Details
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Organization Details
Stryker