Job Description Summary

Staff Test Method Development and Validation Engineer

Job Description

We are the makers of possible 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Within our CC/IS/IPS (Catheter Care Injection Systems and Infusion Preparation Disposables) business, the Medication Delivery R&D team is seeking a Staff Product Engineer, to join us. In this exciting role, you will impact health care by driving commercialization of new products and design changes for current products through all phases. You will use your experience and expertise to plan, design, build, and qualify measurement systems and methods vital to the evaluation of product safety, efficacy, performance, and compliance while ensuring accurate completion of project and business goals. You will develop and drive the strategy and execution of product design verification and validation activities to demonstrate product safety, efficacy, performance, and compliance. You will support the development of the product designs and associated requirements to efficiently demonstrate their safety and efficacy. 

Duties & Responsibilities 

• This role will provide subject matter expertise (SME) in the areas of: 

• Mechanical and analytical testing development and methodologies for medical devices, materials, and combination products. 

• Including leading and supporting routine and non-routine USP, ASTM, ISO, and product performance and function testing. 

• Develop test methods and craft requirements in the subject matter area which follow innovative and industry practices and standards not limited to USP, ASTM, and ISO. 

• Apply rigorous and innovative approaches for development of test methods for novel and non-compendial product evaluations. 

• Understand and proliferate standard methodologies as it relates to testing 

• Be versed in statistical analysis of method outputs, sample sizes related to and used in method validation and design verification. 

• Plan and support through all project phases, with a focus on the strategy and execution of measurement system development/qualification, design verification and design validation. 

• Independently support product development projects and effectively define problems, collect, and interpret data, establish facts, draw valid scientific conclusions, and propose solutions or corrective actions. 

• Craft, edit, and interpret technical drawings and technical reports and write protocols, reports, work instructions, presentations, etc.  

• Expertly apply engineering principles for design/analysis and complete statistical analysis and sample plan development. 

• Demonstrate accountability for the successful and timely achievement of goals. 

• Present to peer and customer audience on area of expertise to empower the organization and disseminate data and conclusions. 

Education & Experience 

• Minimum 5-6 years of experience in medical device or other regulated industry OR Master's Degree in Mechanical or Biomedical Engineering and 5+ years of experience OR PhD in Mechanical or Biomedical Engineering and 3+ years of experience. 

• Expertise with test method development, validation strategy, and execution is required. 

• Expertise with design verification & validation strategy development and execution is required. 

• Strong track record of technical problem solving and effective product development through expert application of engineering principles is required. 

• Design controls expertise  

• Experience with traditional and modern fabrication techniques is required. 

• Experience in packaging testing methodologies and industry standards is a plus 

• Experience in solid modeling (SolidWorks) or electromechanical systems is a plus. 

• Experience in high-volume manufacturing processes is a plus. 

• Experience developing and commercializing medical devices is a plus 

• Exposure to Chemistry/ Chemical Engineering and/or structural analysis and simulation/mathema