R&D Engineering Fellow

The ideal candidate will combine technical expertise with leadership skills to deliver impactful results.

Your Responsibilities Will Include:

• Lead and direct project teams, ensuring successful execution of technical work related to product design and development.
• Provide technical and professional guidance to team members, fostering a culture of innovation and excellence.
• Drive the technical analysis of medical device systems and materials for new and existing products, ensuring compliance with quality and regulatory standards.
• Gather and analyze requirements from internal and external stakeholders to capture user needs and translate them into actionable product designs.
• Innovate and create new product concepts and designs, contributing to the company’s IP portfolio through invention disclosures and patent applications.
• Assist in Design for Manufacturing (DFM) activities to ensure seamless scalability of designs.
• Lead investigations into failure modes and perform root cause analyses to address technical challenges.
• Ensure compliance with relevant regulatory requirements and standards throughout the product lifecycle.
• Engage in discussions with cross-functional and cross-team stakeholders to drive results and execute activities efficiently.
• Leverage organizational resources to identify and implement new capabilities and solutions.
• Develop and maintain strong relationships with internal stakeholders, healthcare professionals, and suppliers.
• Present project updates, technical insights, and strategic recommendations to senior management.
• Review engineering documentation, including technical reports, DHF (Design History File), and DMR (Device Master Record), ensuring adherence to quality systems and policies.
• Monitor industry trends and technological advancements to identify opportunities for innovation and improvement.
• Contribute to the company’s strategic initiatives by developing creative solutions that address market needs and challenges.
• Ensure adherence to the company’s health and safety policies, reporting unsafe working conditions when identified.
• Work effectively in an inclusive, collaborative, and fast-paced environment with minimal direction.
• Travel domestically and internationally (approximately 10%) as required.
• Perform other duties as needed to support organizational goals.

Required Qualifications:

• Bachelor’s degree in biomedical engineering, mechanical engineering, or a related field.
• 5+ years of relevant technical experience.
• Experience working within a quality management system and quality system controls (e.g., design inputs/outputs, verification/validation).
• Knowledge of the design requirements as per 21 CFR 820 and ISO 13485.
• Technical leader with a self-starter attitude and a hands-on approach.
• Ability to work independently and within a diverse group of engineers.
• Strong communication skills (verbal and written).

Preferred Qualifications:

• Experience working within medical device R&D departments, with hands-on prototyping and testing.
• Knowledge of cardiac applications.
• Experience with catheter device development.
• Familiarity with industry-related standards (e.g., ISO, ASTM, ASME, IEC) and their direct application.

If you meet the qualifications and are interested in this opportunity, please submit your resume today. While we respect all interested candidates, only profiles meeting the qualifications will be contacted for further discussion. Thank you.