Principal R&D Engineer, Delivery Systems
Massachusetts
Talent Solutions - External Opportunities – Medical Affairs /
Full-time /
Hybrid
Notice: MCRA’s Talent Solutions division works to unite top talent with opportunities on our clients’ teams. This posting is not for a position directly at MCRA, but rather for a position with an MCRA client that our team is helping to recruit and fill.
MCRA Talent Solutions is proud to partner with an innovative company in the tricuspid valve space to identify a Principal R&D Engineer, Delivery Systems. This is a unique opportunity to join a fast-growing startup developing transformative cardiovascular technology. The selected candidate will lead ongoing development of advanced delivery system designs and play a key role in bringing next-generation therapies to patients.
This role is responsible for ongoing research, development, testing, and manufacturing oversight of delivery system products. The Principal R&D Engineer will execute complex engineering assignments, lead external partnerships, and contribute across the full product development lifecycle, from concept to clinical stage.
Responsibilities
- Lead the continuous development of delivery system designs, including CAD modeling, prototyping, testing, documentation, and the creation of pilot manufacturing and assembly processes.
- Ensure delivery system designs meet performance, manufacturability, quality, reliability, and usability requirements.
- Manage contract partners for development, manufacturing, and testing.
- Lead transfer of product from prototype through design verification and into clinical production.
- Drive planning and execution of preclinical testing programs (e.g., bench, animal, biocompatibility).Support and maintain compliance with the company’s Quality Management System (QMS).Contribute to design control activities including requirements development, risk management (e.g., FMEA), and design documentation.
- Use SolidWorks and/or Autodesk Inventor for modeling and drawing creation/modification.
- Conduct root-cause investigations when needed.
- Support clinical procedures by preparing devices and providing technical guidance.
- Assist with intellectual property filings by identifying inventive features and supporting patent prosecution.
- Support R&D hiring efforts and manage engineers/technicians, as applicable.
- Perform other duties as assigned
Qualifications
- Strong technical and analytical problem-solving skills
- Highly organized and detail-oriented
- Self-starter able to work independently
- Collaborative team player with excellent interpersonal skills
- Strong written and verbal communication
- Ability to manage multiple priorities simultaneously
- Passion for medtech innovation and startup environments
- Comfortable making decisions with limited information
- Willingness to travel as needed (vendors, partners, clinical sites)
Education & Experience
- Bachelor’s degree in Engineering or related field
- 8–10 years of R&D and/or manufacturing engineering experience
- Expertise in design and testing of complex, steerable delivery systems — preferably for cardiovascular and/or transcatheter valve replacement applications
- Supervisory experience preferred
$160,000 - $175,000 a year
