Summary Description

• Lead research and development projects focused on the creation of new products and improvements to existing products through an understanding of the underlying science and technology.  Manage development projects focused on IVD devices that use cellular, molecular, and/or immunoassays through definition of requirements, design reviews, product manufacturing and testing.

Job Duties:

• Oversee and manage design-controlled product development efforts including definition of proper and testable product requirements, definition of product development milestones, conducting design reviews, and rigorous testing & analysis in support of verification and validation activities. 
• Responsible for the cost, schedule and technical performance of company projects or subsystems of major programs.  Provide reporting and visibility to executive management.
• Coordinate the efforts of multidisciplinary teams of internal resources and external partners/subcontractors to successfully execute product development activities.
• Act as primary customer and supplier contact for project activities, leading project review sessions with internal and external parties to discuss cost, schedule and technical performance. 
• Lead the design of experiments, including the statistical analysis approach.
• Deliver analyses, test results and reports that support design control compliance with regulatory guidance.
• Author design verification and validation protocols and reports, design inputs, design outputs, specifications, risk documents, package inserts and regulatory submissions. 
• Identify potential collaborators for technology and product development efforts. 
• Perform technology assessments and make scientifically supported recommendations for promising technologies and initiatives most likely to achieve customer and company objectives and requirements.  Stay informed of current state of the art in relevant scientific and technical areas.
• Support business development and proposal activities, as applicable

Required Qualifications:

• Bachelor’s degree in related field
• 10+ Years of experience with IVD development. 
• Prior history working in an FDA and/or ISO regulated development environment; specifically 21 CFR 820 and ISO 13485
• Knowledge of FDA 510(k)/PMA/De Novo process strongly preferred
• Verification and Validation experience with FDA-cleared or approved IVDDs
• Experience with design of experiments, statistical analysis techniques, and data analysis tools

Additional Attributes

• Knowledge of FDA 510(k)/PMA/De Novo process strongly preferred
• Verification and Validation experience with FDA-cleared or approved IVDDs
• Experience with design of experiments, statistical analysis techniques, and data analysis tools
• Strong aptitude with Microsoft Office products, such as Word, Excel, and PowerPoint.
• Ability to interact with multidisciplinary colleagues in a team environment
• Proficient organizational, record keeping and communication skills (oral and written), with excellent presentation technique
• Strong work ethic to generate high quality work under tight deadlines
• Demonstrated leadership and self-motivation.  Ability to motivate and guide others to meet objectives and drive actions to closure.

ASELL is a medical device developer that is working with government customers to turn science into solutions.  ASELL is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, or national origin.

www.asell.com