Research and Development Biomedical Engineer

Location: University

The University of Mississippi — fondly referred to as Ole Miss — stands as a premier public research institution with a proud legacy of academic distinction. We are devoted to nurturing a vibrant, inclusive community where every member — student, faculty, and staff — can achieve their fullest potential.

Job Summary:

This position services the Center for Diagnostics, Design, Devices and Biomechanics (D3B). The Center for Diagnostics, Design, Devices and Biomechanics (D3B) is seeking a R&D Engineer to lead the design, development, and testing of medical devices from concept through validation within the guidelines of FDA 21 CFR 820.30 and ISO 13485. In addition, this role will manage the day to day operations of D3B, supervise students and researchers performing activity in the Center, and establish project milestone schedules to ensure efficiency.

This role combines hands-on engineering work — CAD modeling, prototyping, mechanical testing, and finite element analysis — with the interpersonal skills to collaborate directly with surgeons, clinical partners, university researchers and multidisciplinary project teams. The ideal candidate is a proven problem solver who can operate independently, manage projects from ideation to product within FDA and ISO regulations, and communicate effectively with engineers, researchers, industry leaders and clinicians.

The R&D Engineer is D3B’s technical authority for device development. They take medical device concepts from clinical need to design-verified prototype and prepare the engineering record needed to hand a design to an industry partner, to support a regulatory submission, or to reach first-in-human evaluation.

Job Description:

D3B is seeking a R&D Engineer, the technical role that the medical device industry uses for an experienced individual-contributor engineer. The R&D Engineer is D3B’s technical authority for device development. They take medical device concepts from clinical need to design-verified prototype and prepare the engineering record (e.g. Desigh History File, DHF) needed to hand a design to an industry partner, to support a regulatory submission, or to reach first-in-human evaluation.

The R&D Engineer works directly with surgeons and clinical partners to define unmet needs and turn them into design inputs. They lead design work in CAD and simulation, and they plan and run verification testing to recognized consensus standards (e.g. ASTM, ISO). They keep D3B’s design-control and risk-management practices consistent with Regulatory standards such as FDA 21 CFR 820.30, ISO 14971, and ISO 13485, so that university-developed devices can move into commercial development with an industry partner without being re-engineered.

The position also serves as technical lead and point of contact for industry-sponsored research and testing agreements. It contributes the engineering content of grant proposals, invention disclosures and patents, and it runs the day-to-day technical operations of the Center, including project schedules and the engineering development of the students and research staff on D3B projects.
1. Medical device design and development (design authority)
Leads the design and development of medical devices (for example, orthopedic and spinal implants, surgical instruments and diagnostic devices) from needs identification and concept generation through prototyping, design verification and design transfer consistent with FDA 21 CFR 820.30 and ISO 13485 expectations.

Turns clinical and user needs, gathered through surgeon interviews, observing procedures and cadaver labs, into measurable, verifiable design inputs and product requirements.

Develops parametric 3D CAD models, assemblies and detailed engineering drawings, including…