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Job Details
This senior-level Engineer will lead R&D efforts relating to sustaining and design improvements for Disposables products. Responsible for multiple sustaining projects primarily focused in the areas of product lifecycle management with a focus on ensuring design control.
Responsibilities for this senior-level R&D Product Development Engineer may include:
Providing technical and project leadership directing product sustaining initiatives of varying size, scope, and complexity with effective management of project Scope, Time, Budget, and Communication.
Well-versed in Medical Device Design Control; including experience in managing DHFs, authoring requirements, specifications, etc.
Leads CAPA root cause investigations on design-related issues, develops business-centric corrective and preventative actions, manage action effectiveness, and be responsible for quality record documentation.
Manages Disposables designs with Computer Aided Engineering (CAE) tools and oversees Geometric Dimensioning and Tolerancing (GD&T) design evaluations.
Manages Supplier Change Notifications and works with procurement teams on design-related initiatives.
Manages design-related changes utilizing a disciplined approach to Change Control Methodology.
Develops and analyzes statistical study designs (DOE, ANOVA, etc.) for feasibility and design verification of Disposables.
Collaborates and interfaces extensively within and outside R&D. Works effectively with multiple diverse technical and business functions and uses tact and discretion to resolve conflicts.
Displays solid written and verbal communication through presentation skills, and effectively communicates with customers, multiple teams and diverse stakeholders across the company.
Collaborates and influences others on cross-functional teams advancing partnerships to achieve business objectives.
Experience with operating within a Global R&D organization.
Ability to travel to internal, supplier and customer facilities.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's Degree in Engineering fields (Mechanical, Biomedical / Bioengineering, Chemical, Materials Science).
3+ years of relevant experience
Experience with Medical Device and ISO13485 Quality Systems
CAPA Owner and Investigator experience
Lean Six Sigma Green Belt Certification
Experience in Statistical Study Design (DOE, Regression Analysis, ANOVA, etc.)