Senior Research And Development Engineer

SUMMARY

The Senior Research &Development Engineer will support the design and development of innovative medical devices, contributing to the company’s mission of advancing healthcare technologies. This role will specifically develop and optimize self-expanding nitinol stents and catheter delivery system through all phases of the product life cycle and involves design, prototyping, testing, documentation and manufacturing support while ensuring compliance with FDA and ISO standards.

ROLES AND RESPONSIBILITIES

Design and Development:

·       Lead the design, prototyping, and testing of new self-expanding nitinol stents, line extensions for current stent designs, and new medical devices combined with amnion.

·       Assist with the design, prototyping and testing of catheters for delivery of the nitinol stents.

·       Design fixtures for testing of nitinol devices/stents and associated delivery catheters.

·       Assist in the development of new techniques to combine a medical device with biologics.

Supplier Management:

·       Collaborate with, and manage the work of, suppliers to achieve corporate goals for product delivery.

·       Identify suppliers and partners to develop and supply next generation technologies.

Data Analysis:

·       Perform data analysis to support engineering decisions and ensure product performance.

·       Utilize statistical techniques to provide rationale for test sample quantities and data analysis.

Documentation:

·       Create and maintain detailed documentation for design control, regulatory submissions, and intellectual property protection.

·       Author detailed test protocols and reports.

Testing and Validation:

·       Conduct experiments, verification and validation testing to ensure devices meet regulatory and quality standards.

Cross-Functional Collaboration:

·       Work closely with other departments, including Quality, Regulatory, Marketing, and Manufacturing, to ensure seamless product development.

·       Collaborate and engage with physicians to develop appropriate design inputs for next generation products.

Continuous Improvement:

·       Participate in continuous improvement initiatives to enhance the efficiency and effectiveness of R&D processes.

Regulatory Compliance:

·       Ensure all activities comply with relevant regulations and standards, including ISO 13485 and FDA guidelines.

·       Assist with addressing FDA requests and questions.

MINIMUM EXPERIENCE AND EDUCATION REQUIREMENTS

·       Bachelor’s degree in mechanical engineering, biomedical engineering or a related field; advanced degree (Mechanical or Biomedical preferred).

·       5 years of experience in nitinol stent design and manufacturing.

·       5 years of experience with disposable medical devices and permanent implant design.

·       Proficient in CAD software (e.g., SolidWorks), FEA software and other engineering tools.

·       Strong technical expertise in nitinol manufacturing processes for supporting projects in development and production.

·       Strong knowledge of materials science, prototyping, and product design.

·       Ability to perform light tool room tasks to develop prototype designs and fixtures.

·       Analytical and problem-solving skills.

·       Understand Good Manufacturing and Documentation Practices (GMP and GDP), 21 CFR Part 820, ISO13485. Experience with MDSAP implementation desired.

·       Experience with conducting preclinical studies.

·       Experience with human tissue and CFR 1271 is preferred.

·       Collaborate with, and manage the work of, suppliers to achieve corporate goals for product delivery.

·       Direct and manage the work of external testing suppliers.

·       Ability to conduct feasibility studies and perform root-cause analysis.

·       Experience managing timelines and documentation.

·       Cross-functional collaboration skills.

·       Ability to communicate complex ideas to non-technical teams.

·       Technical writing for regulatory compliance and testing.