R&D Principal Engineer (R&D Systems Team)

Description

Support and lead cross functional teams in the design and development of novel medical devices and manufacturing processes. This includes being a primary contributor to both product and process development of new technologies used for device concepts.

Responsibilities

• Engineering lead in OUS submissions (Europe and Asia) and optimizing more complex issues, including new technologies or processes pertinent to medical device design and manufacturing.

• Develop and execute novel processes, test methods, parts, components, subsystems, products, or complete systems. This includes establishing design requirements, generating design concepts and prototypes, manufacturing process controls, experimental testing, data analysis, and/or conducting pre-clinical evaluations.

• Establish product and system specifications to satisfy clinically relevant requirements.

• Proactively identify issues, achieve resolution, and resolve problems of highly significant complexity.

• Generate and evaluate pertinent intellectual property.

• Supervise and/or mentor engineers, technicians and specialists.

• Largely self-directed, capable of meeting project goals with minimal supervision.

• Evaluates the biocompatibility test outcomes to ascertain whether the data sufficiently meets the criteria for biological effects and employs technical expertise and analytical skills to address any unforeseen results.

• Assists in addressing regulatory inquiries pertaining to past biocompatibility reports to facilitate domestic and international registrations.

• Directs testing activities with current and new suppliers; identifies 2nd source suppliers for biocompatibility and other related testing of new products.

• Other duties as assigned.

Qualifications

• BS engineering degree with 8+ years of related experience

• Excellent written and verbal communication skills.