R&D Disposables Engineer II

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job Details

This Disposables Engineer II 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 Disposables Engineer II may include:

• Provides 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 DHF documentation and authoring requirements.

• 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.

Requirements and Education:

• Bachelor's Degree in Engineering fields (Mechanical, Biomedical / Bioengineering, Chemical, Materials Science).

• 1.5 - 3 years of relevant experience

• Experience with Medical Device and ISO13485 Quality Systems

• CAPA Owner and Investigator experience

• Experience in Statistical Study Design (DOE, Regression Analysis, ANOVA, etc.) a plus

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