5+ years leading development of disposable medical devices
Experience in design and process development for medical device catheters
Familiarity with FDA and ISO standards for medical device design
BS in Mechanical or Biomedical Engineering
Knowledge of catheter materials and construction methods
Proven track record from concept to product launch
Self-motivated with minimal supervision required
Responsibilities
Design and prototype novel catheter-based products
Collaborate with cross-functional teams for product evaluation
Prepare technical documentation for regulatory submissions
Provide project status updates periodically
Contribute to intellectual property through invention disclosures
Engage with physicians for product testing and demonstrations
Train team members on product assembly and troubleshoot issues
Maintain Design Control activities from concept to commercialization
Benefits
Support for professional development and training
Collaborative work environment with cross-functional teams
Opportunity to contribute to innovative medical solutions
Involvement in intellectual property development
Engagement with healthcare professionals for product insights
Full Job Description
SUMMARY
The Senior R&D Engineer is responsible for the design and development of new and improved products and procedures that address vascular diseases and conditions using minimally invasive techniques.
PRINCIPAL DUTIES AND RESPONSIBILITIES
Design, prototype and develop novel design solutions for catheter-based products to improve performance and ease of use in clinical procedures.
Work as part of a cross-functional team to develop and evaluate product designs through verification and validation testing
Prepare technical documentation, including manufacturing instructions, test methods, protocols, and reports to support design control activities and regulatory submissions
Provide periodic updates regarding project status
Contribute to the company's intellectual property via invention disclosures, brainstorming sessions, and prototypes to demonstrate reduction to practice
Interact with physicians regarding product development, testing, and product demonstrations
Train other team members on product assembly; troubleshoot assembly process issues
Maintain Design Control activities for new product development from initial concept through commercialization. These activities may include the following: developing product specifications, performing robust design evaluation, creating risk analyses, meeting goals for design reviews, and setting & executing design verification and validation strategies.
Work collaboratively with other company functions as needed, including R&D, Marketing, Operations, Quality, Clinical and Regulatory to ensure project success.
Support the development and upkeep of the Company's Quality System in conjunction with the Company's Quality Department.
EXPERIENCE REQUIREMENTS
At least 5 years' experience leading development of disposable medical device products.
Experience with design and process development of medical device catheters.
Experience with FDA and ISO standards for medical device design controls and manufacturing
EDUCATION REQUIREMENTS
BS Engineering (Mechanical or Biomedical)
OTHER QUALIFICATIONS
Working knowledge of common catheter materials and construction methods.
Successful track record of developing medical disposable products from conceptualization through product launch
Self-motivated with ability to work independently and with minimal supervision
