An R&D Engineer in the development team is a leader in the department tasked with researching clincal problems, developing medical device design solutions. This includes management of external designers and suppliers, and driving the completion of design control and risk management activities. Project areas may include interventional radiology devices like drainage catheters, percutaneous access sets and vascular access sheaths.
• Work closely with physicians and other customers to develop design solutions for clinical problems
• Gather clinical application information, performance requirements and user needs; perform requirements and risk analyses.
• Create review and approve documentation related to design and transfer
• Coordinate cross-functionally (including with external design firms) to establish design input requirements, traceability tables, risk and hazard analyses.
• Act as a mentor to other personnel in the Engineering department as it relates to practical and compliant execution of design controls and risk management activities during development phases
• Contribute technical/scientific expertise and direction to department engineers and other company business functions
• May act as project lead, coordinating cross-functional work and maintaining overall project plan
• Assure that project deliverables and tasks are technically excellent and completed in a timely fashion.
• Design and coordinate execution of design verification and product, process, and method validation activities.
• Utilize technical expertise for interpreting data, organizing, executing, and coordinating project activities
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Must maintain company quality and quantity standards
• Must have effective oral and written communication skills
• Bachelor's degree in Engineering
• Minimum 5yrs, experience in Class II/III medical device manufacturing
• Current knowledge and application FDA 21CFR820, ISO 13485
and ISO 14971
• Preferred experience in managing projects and external designers and/or suppliers.
• Experience with Project Management
• Experience working independently
• Experience in communication, working with a wide variety of associates, and directing others towards a common goal
• Personal protective equipment including safety glasses, lab coat and gloves required in many areas associated with this position
• Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
• Works under general office environmental conditions