Project Engineer, Mechanical Testing

POSITION SUMMARY: 

The Project Engineer, Biomechanics conducts and documents device and instrument testing related to new product development of orthopedic implants. Knowledge of biomechanics and engineering principles is applied to ensure product safety as well as compliance with medical device regulations. The Project Engineer works under supervision and is part of a cross-functional product development team.    

KEY AREAS OF RESPONSIBILITY: What you will do: 

Technical Responsibilities:  

Conduct verification and validation testing of medical devices. This can include mechanical, wear, corrosion and other standardized or non-standardized testing. 

Under supervision, develop or adapt test methods to fit product testing needs and create standard operating procedures. 

Support problem solving, root cause analysis, identify potential solutions, and evaluate them against requirements.  

Under supervision, conduct research and studies to support product design. 

Business Responsibilities: 

Understand the product’s intended use, function and clinical procedures. 

Develop test plans and protocols and manage testing campaigns. 

Manage external testing projects.  

Med Device Compliance: 

Understand fundamental industry standards and testing strategies which align with regulatory requirements.  

Under supervision, create engineering documentation, such as test reports and engineering memos. 

Learn relevant R&D and Biomechanics procedures and gain an understanding of risk management per the Quality Management System.  

Become familiar with standardized test methods per ASTM/ISO as well as relevant FDA/regulatory guidance. 

Understand and champion laboratory best practices and compliance. 

General Responsibilities:  

Under supervision, work with R&D, Product Development, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success. 

Learn procedures, policies, processes, systems, and relevant technology. 

Demonstrate ownership and integrity of work. 

Build stable relationships. 

Contribute to projects as a team member. 

PREFERRED QUALIFICATIONS: What you will need (strongly desired): 

Technical Skills:  

Fundamental knowledge and understanding of mechanical testing (and more broadly, device testing), within a regulated environment. 

Basic knowledge of analytical tools and statistical methods. 

Basic knowledge of materials and manufacturing methods.