Cresilon, Inc.
Biotechnology
SeniorMedicalDeviceResearchandDevelopmentEngineer
“Senior Medical Device Research and Development Engineer at Cresilon, Inc.. Skills: Medical device development, Product development, Research and development. Lead design and development activities. Improve existing products”
What You'll Achieve.
Dominate the marketplace; Improve healthcare; Drive purposeful innovation; Result in best-in-class products
Industry & Context.
Problem-solving skills; Analytical skills; Decision-making skills; Creative problem solving; Complex problems
What They're Looking For.
Must Have
BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related scientific degree, Demonstrated ability to solve difficult technical problems, Demonstrated ability to design experiments and analyze data, Demonstrated ability to work independently and effectively as a team contributor, Ability to handle multiple project assignments, Ability to lead directly and by influence, Requires leadership skills, Excellent written and verbal communication and presentation skills, Working knowledge of FDA requirements as per 21 CFR 820, ISO 9001, ISO 13485:2003, and ISO 14971:2007, Working knowledge of Good Documentation Practices (GDP), Working knowledge of Good Manufacturing Practices (cGMP), Good understanding of statistical tools and validation/verification techniques, Proficiency in Microsoft Excel, Word, and PowerPoint, Legal authorization to work in the United States
Nice to Have
Advanced degree (MS or Ph. D.), Hands-on experience with Class II and Class III medical devices, Experience developing test methods and protocols/reports for safety and efficacy testing, Experience with IDE and PMA submissions, Six-Sigma green belt or black belt certification
What You'll Do.
Lead design and development activities
Improve existing products
Author technical documents
Provide project-specific support
Perform technical analysis
Characterize product performance
Generate data through experiments
Create experimentation for research
Define new product functional requirements
Evaluate design effectiveness
Lead cross-functional teams
Address design issues
Maintain existing designs
Solve complex problems
Plan and schedule activities
Work cooperatively with quality
Lead creation of design history file documentation
Develop implant and instrument designs
Generate technical protocols/reports
Submit invention disclosures
Ensure design activities adhere to FDA Quality System
Ensure design activities adhere to ISO 13485
Lead material/design/process changes
Author protocols and reports
Develop and execute test methods
Conduct chemical property evaluation tests
Conduct mechanical property evaluation tests
Exercise technical judgment in experiments
Interpret experiments
Prepare samples for testing
Perform data analysis
Interface with customers
Interface with suppliers
Coordinate prototype fabrication
Maintain laboratory notebook
Maintain technical documentation
Maintain dialogue with Regulatory Affairs
Support marketing and sales team
Develop presentations
Develop applications data
Communicate results to scientific community
Present research at symposia
Manage part-time staff
Mentor research staff
Evaluate research practices
Contribute to culture of research operations
Provide project support
Provide product support
How You'll Work.
Team & Collaboration
Multidisciplinary team; Cross-functional teams; Internal cross-functional team members
Communication Scope
Verbal communication; Written communication; Presentation skills; Published papers; Scientific community communication
Process & Methodology
Project timelines, Project success, Project assignments
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