R&D Design Engineer
Are you:

• Someone who wants to bring new medical device product ideas to life by utilizing CAD/FEA software and rapid prototyping technologies?
• Someone who is technically competent, dedicated to teamwork and communication, and desires a small company work environment?
• Someone who is eager to interact directly with patients and see their innovative product ideas working to improve lives?

Ultraflex Systems, Inc. is a small, growing, manufacturer of technologically advanced medical devices whose mission is to humbly serve the therapeutic and definitive orthotic and prosthetic (O&P) needs of patients with severe neuro-muscular and/or orthopedic dysfunction.  We are committed to becoming a great R&D company to solve real, unmet patient needs within the rehab and disability community. 
We have a need in our Pottstown, PA facility for a proven, strong, serious, focused, hands-on design engineer.  The successful candidate will be technically very strong in the areas of concept, analysis, problem solving, drafting, design review, etc. to bring breakthrough technologies to help those with disabilities. 
Responsibilities

• Participate in product development process to define clinical and technical design parameters, complete priority projects based on patient needs/R&D risks, plan task responsibility, and meet product introductions deadlines
• Participate in development of improved manufacturing methods to realize lean manufacturing initiatives
• Participate in development and on-going optimization of uniform systems for product development (CAD/CAM, FEA, project management, engineering, manufacturing, and intellectual property documentation/attainment)
• Work with Clinical Affairs and outside clinical advisers on all beta testing of prototypes. 
• Assess all emerging technology in materials, testing, scanning, modeling, CAE etc. in both assistive technology and in general industry to optimize product development
• Participate in periodic design reviews to achieve elegant, functional and simple designs
• Report results (benchmarks, goal attainment, budgets) as required to the R&D Team Leader
• Implement and continuously improve all R&D systems - project management, change orders, FDA/CE, testing/validation and intellectual property attainment
• Exceed all regulatory requirements for FDA registration/approval, CE mark and complaint processing from patient users
• Utilize Microsoft Project to track activities, milestones, time and cost and use this for reporting status to the R&D Team Leader

Qualifications

• BS/BA in biomedical, biomechanical, mechanical or electrical engineering required
• Minimum 3 years experience in the successful development and introduction of new proprietary medical device technology in a start-up or small company environment - less than 100 employees
• Knowledge of regulatory/market issues common in medical device product development a plus
• Thorough understanding and proficient technical knowledge of AutoCAD, Solid Works or Solid Edge and FEA software
• Training in human motion analysis in a clinical or research setting a plus
• Detail oriented
• Excellent interpersonal and communication skills
• Experienced in use of Microsoft Project

If you are energized by collaborating with outside clinical advisors/researchers and customers to advance new product development (concept, validation, manufacturing, introduction and on-going revision), this job is for you. 

If you meet these requirements, we encourage you to provide a cover letter indicating why you are the ideal candidate for this position.  Take advantage of your ability to upload a cover letter with your resume. Please include a salary requirement in your cover letter.

We offer a competitive salary based on experience and a comprehensive benefits package.

Relocation is not offered for this position.

Applications without salary history will not be considered.  EOE