|Requisition ID: ||46808 |
|Title: ||IT Sr System Engineer - Computer Aided Design |
|Division: ||Arthrex, Inc. (US01) |
|Location: ||Boston MA |
Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics.Arthrex is actively seekinga PLM Systems Engineer who works directly with the Product Development and Quality departments within Arthrex to manage a pipeline of Information Technology projects and enhancements. A successful candidate must have experience defining and operating business processes in the following areas: Product Management, Design Engineering & Quality. The position liaises with the technical organization to determine the timing and cost of specific projects. Excellent communications and analytical skills, strong technical project management skills and a Bachelors degree will be essential for this position.Join our talented team at a global medical device company focused onHelping Surgeons Treat Their Patients Better. We are open to this role being located in our Naples, FL , Boston or Remote work from home for the right situation.
Essential Duties and Responsibilities:
- Translate business goals and objectives into strategic business capabilities.
- Develops roadmaps that defines business strategy; facilitates identification of key business strategy elements.
- Analyze business process requirements and develop functional/system specifications.
- Ensure appropriate regulations, such as 21 CFR Part 11, 820 and cGMP regulations, are addressed in software validations
- Coordinate, assist and document validation activities; preparation/approval of protocols and reports.
- Articulate design considerations, trade-offs, benefits, and recommendations for technical solutions with scalability and supportability in mind.
- Collaborate with internal and external technical resources performing analysis, design, configuration, development, testing, and deployment activities for Computer Aided Design applications as well as PDM technologies.
- Provide technical guidance to application development teams, consult on integration and conversion issues and participate in mapping technology-independent application architecture to the chosen technology platform.
- Assess the impact of system changes thru change management and change control systems; participate in the planning and implementation of change.
- Provide training to colleagues and contractors on our approach to systems implementation, testing and validation SOPs.
- Assist validation activities of cross functional teams that include technical functions such as IT, SQA, Business Subject Matter Process Experts.
- Conduct research on emerging technologies in support of objectives and recommend technologies that will increase cost effectiveness, flexibility, and innovation.
- Focus on the long-term architecture and strategy for solutions that enable operations.
- Define, champion and govern business standards, tools, best practices, and development methodologies.
- Up to 20% travel required.
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
- Bachelor's degree required, preferably in Business, Engineering or Computer Science or related field required. Masters degree in Business or Engineering preferred.
- At least Eight years experience within a business function (Quality, Manufacturing, or Engineering) with business analysis, business process improvement, Software Quality Assurance and Validation activity required.
- Must have thorough understanding of 21 CFR 820 and Part 11, cGMP regulations and software validation guidance and/or requirements.
- Previous position in Pharma or Medical Device industry.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
- Experience with SolidWorks Designer, Advanced SolidWorks Modeling and Simulation technologies.
- Capable of defining best practices and troubleshooting modeling issues.
- Experience with implementing Model Based Design\Engineering methodology within a global engineering environment.
- Strong understanding of ASME y14.5-2009.
- Advanced knowledge and usage of GD&T practices.
- Usage of PDMLink, Creo and AutoCAD a plus.Previous position in Pharma or Medical Device industry.
- Experience with GAMP 5 and DevOps Frameworks.
- Experience with process improvement techniques and tools. Lean or Six Sigma preferred.
- Strong communication (written and oral) and presentation skills.
- Ability to work comfortably at all levels within the organization up to the senior management level.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.