R&D ENGINEER I - APTYX

The R&D Engineer I position performs the function of design engineer for product development work on medical devices in the Development department in support of the department’s objectives to provide goods and services that meet customer requirements for quality, quantity, and timeliness.
The primary role of an R&D Engineer I is to lead project deliverables and lead technical reporting of such deliverables to customers on time and on budget to meet customer objectives, and therefore bring projects to successful conclusions.

QUALIFICATIONS

• Technical skills must include disposable design and development background, materials knowledge, and prototyping
• Project management experience is highly preferred to plan and conduct complex development projects

EDUCATION

• BS or MS in Biomedical or Mechanical Engineering is required

EXPERIENCE

• 3-5 years of experience in engineering for medical devices
• Proficient with SolidWorks or equivalent

SKILLS, KNOWLEDGE, AND ABILITIES

• Strong analytical and problem-solving skills
• Excellent verbal and written communication skills are essential
• Computer skills including MS Office, SolidWorks, or alternative CAD program

• Responsible for following the Quality system, including all applicable SOPs included in the Training Matrix
• Develop and engineer disposable medical devices from concept to production
• Hands-on products and process development of catheters and other disposable products
• Design devices in SolidWorks and build prototypes in a laboratory environment
• Design, prototype, and construct catheters, catheter-based delivery systems, and other disposable devices for disciplines ranging from cardiology and neurology to urology
• Acquisition, setup, and installation qualification of new equipment, including the creation of PM procedure as necessary
• Support of equipment maintenance, as appropriate for skills and knowledge
• Support or perform equipment re-entry to line use
• Communicate with the customer about any issues and the status of the project
• Prepare and support product development and quality planning (project schedule, resources, budgets, etc.)
• Participate in the quotation process for projects
• Develop feasibility and reliability testing plans for catheter systems, including the development and validation of accurate in-vitro and in-vivo models and methods
• Develop pilot and manufacturing equipment and procedures for devices
• Assess feasibility of processes and support manufacturing with validation plans and time studies
• Support product manufacturing until the project is fully transitioned to production
• Manage and assist with verification and validation activities and documentation
• Collaborate with outside vendors on the sourcing of catheter materials, components, and processing
• Prepare documentation to support quality system for design functions (project plans, concept document, FMEA, design input, test results, drawings, etc.)
• Complete activities as project phase checklists. Engage and handoff activities to manufacturing engineering
• Support customer complaints
• Lead design changes to existing product lines as necessary
• Review document changes in manufacturing for impact on design intent
• Demonstrate understanding of the D&D process by showing independence by recommending project direction and initiating project tasks to meet deliverables
• Demonstrate competence of product development by communicating status and recommendations to customers
• Gain customer satisfaction through adequate communication