Lead R&D Engineer for Medical Device Development
We are seeking a highly skilled Principal R&D Engineer to lead the development of cutting-edge medical devices. Reporting to the VP of R&D, this key role will oversee product development from design through verification, clinical trials, validation, and regulatory approval.
* Manage system-level design, generating detailed specifications, including review and approval of sub-systems.
* Design systems, selecting robust materials and assembly methods, ensuring finished device specifications meet high standards.
* Source, build, and test systems, driving data analysis to optimize device design.
* Define comprehensive test suites to fully understand device design, risk, and verify/validate it in line with device specifications.
* Proactively manage risks throughout the product lifecycle, driving risk management at an overall system level.
* Ensure device development adheres to good Design Control practices, maintaining a complete audit-ready Design History File.
* Guarantee quality in the product's design for durability, usability, reliability, functionality, marketability, and manufacturability.
* Lead technical discussions with internal and external stakeholders, adapting materials to ensure clear understanding.
* Proactively ensure Company Goals are achieved.
Key Qualifications
* B.S. or master's degree in mechanical engineering, biomedical engineering, or related disciplines.
* Eight years of related experience in medical device mechanical design/product development.
* Cardiovascular medical product development experience preferred.
* Ability to assess in vitro and in vivo properties of devices/device components, including knowledge of implant/tissue interface and challenges.
* Detailed working knowledge of FDA, GMP, QSR, and ISO 13485 requirements.
* Experience interfacing with clinicians and reducing feedback to appropriate designs.
* Excellent organizational and time management skills.
Why This Role Matters
This position is crucial for driving innovation in medical device development, ensuring the creation of life-changing products that improve patient outcomes.