Research and Development Biomedical Engineer @ Olemiss

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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. 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 geometric dimensioning and tolerancing (GD&T) and tolerance stack-up analysis.
• Makes design-for-manufacturability and material-selection decisions for implant-grade materials (for example, Ti-6Al-4V, CoCr, PEEK and 316L stainless steel), taking biocompatibility (ISO 10993) and sterilization method into account.
• Leads formal design reviews and sets technical direction across several concurrent device programs.

2. Computational modeling and simulation

• Plans, runs and interprets finite element analyses (FEA) of devices and device–tissue interactions to inform design decisions, identify worst-case configurations and reduce the amount of physical testing needed.
• Establishes model credibility by verifying, validating and quantifying uncertainty in the models, following FDA/ISO guidance on assessing the credibility of computational modeling in medical device submissions.
• Correlates simulation results with bench and cadaveric test data to refine models and design decisions.

3. Design verification and biomechanical testing

• Develops verification test strategies, protocols and reports based on recognized consensus standards (for example, ASTM F382, F1717, F2077, and F543), and develops new test methods where no standard exists.
• Serves as technical owner of D3B’s servo-hydraulic and electromechanical test systems, including fixture design, test programming, calibration oversight, data acquisition and equipment qualification.
• Designs and directs static, fatigue and biomechanical testing (including cadaveric and synthetic-bone models) and analyzes results statistically to determine whether devices meet their acceptance criteria.
• Leads rapid prototyping strategy (additive manufacturing and outsourced machining) for design iteration and for producing representative test articles.

4. Design controls, risk management and regulatory readiness

• Establishes and maintains design-control practices and documentation for D3B device programs, consistent with FDA & ISO Quality Management System Regulations (21 CFR Part 820 & ISO 13485:2016), including the design history file, requirements traceability, and the design review, verification and validation records.
• Leads risk management activities under ISO 14971, including hazard analysis, design and use failure modes and effects analysis (FMEA), risk-control verification and risk/benefit documentation.
• Applies usability and human-factors engineering principles (e.g. IEC 62366-1) to surgical instruments and user interfaces.
• Assists in the preparation of engineering content for regulatory strategy discussions, pre-submission packages and 510(k) or De Novo submissions led by industry or clinical partners.

5. Translation, commercialization and external partnerships

• Serves as technical lead and primary engineering contact for industry-sponsored research, contract testing and collaborative development agreements, including defining the scope of work, estimating effort and cost, setting deliverables and presenting results to company engineering teams.
• Works with the Office of Technology Commercialization to evaluate the technical feasibility and freedom-to-operate implications of university inventions. Prepares invention disclosures and contributes technical content to patent applications.
• Produces design transfer packages (drawings, specifications, verification evidence and risk files) that let licensees and manufacturing partners move D3B designs into commercial production.
• Writes the engineering sections of federal and foundation grant proposals (for example, NIH, NSF, DoD and SBIR/STTR) and contributes to progress reports and peer-reviewed publications.

6. Clinical collaboration

• Builds and maintains working relationships with surgeons and clinical partners at the University of Mississippi Medical Center and elsewhere. Takes part in clinical needs-finding, cadaver labs and procedure observation.
• Works with research compliance offices on IRB and IACUC matters when device evaluation involves human tissue, human subjects or animal models.

7. Center technical operations and program leadership

• Manages D3B’s engineering project portfolio, including milestone schedules, resource allocation, technical risk tracking and status reporting to the Center Director, sponsors and partners.
• Sets and enforces D3B’s engineering standards, lab safety practices and equipment-use procedures. Approves students and researchers to use test and prototyping equipment.
• Sets capital equipment priorities and writes the technical justifications for new test and prototyping capabilities.
• Directs and assigns the technical work of graduate researchers, undergraduate researchers and research staff on D3B projects.

8. Engineering mentorship

• Serves as technical mentor to biomedical engineering students on capstone design, graduate research and student design-competition teams. Teaches best industry practices related to design-control discipline, test methods and professional engineering practice.
• Gives guest lectures and short courses on industry practice (for example, design controls, FEA credibility and standards-based testing) at the request of the Department.

9. Communication

• Communicates technical findings clearly to engineers, clinicians, industry executives, sponsors and non-technical audiences through technical reports, test reports, design-review presentations, conference presentations and publications.

Job Responsibilities

Qualifications (Required)

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a closely related engineering field or equivalent work experience
• 5–10 years of professional experience in the MedTech / medical device industry or related field
• Demonstrated proficiency with CAD software (e.g. SolidWorks) and experience creating Engineering Drawings and GD&T
• Experience with finite element analysis (FEA) tools and methodology
• Hands-on experience operating mechanical testing equipment or demonstrated ability to learn various mechanical testing systems
• Experience with 3D printing / additive manufacturing for prototyping
• Demonstrated ability taking a product design from clinical need to functional prototype within a FDA 21 CFR 820 and/or ISO 13485 environment while creating an appropriate Design History File with a working knowledge of Risk Management (e.g. ISO 14971)
• Strong project management skills, with the ability to manage multiple concurrent projects
• Excellent verbal and written communication skills, including the ability to communicate effectively with surgeons, industry leaders, researchers and other clinical stakeholders
• Strong interpersonal skills and the ability to work collaboratively across disciplines
• Demonstrated ability to work independently and manage competing priorities
• Understanding of cross functional requirements related to product development – R&D, Quality, Manufacturing, Regulatory, Marketing, Commercial and related business functions
• Familiarity with regulatory and quality standards relevant to medical device development (e.g. FDA 21 CFR 820, ISO 13485)

Preferred Qualification

• Advanced degree (MS) in Biomedical Engineering, Mechanical Engineering, or a related field Experience with orthopedic, spinal or trauma devices and the related ASTM test standards
• Experience with ASME V&V 40 / FDA computational-modeling credibility frameworks
• Experience contributing to 510(k), De Novo or IDE submissions
• Experience incorporating AI and Machine Learning into product development
• Multidisciplinary experience across MedTech, orthopedics, and/or medical device development
• Named inventor on issued or pending patents. Record of peer-reviewed publications or funded proposals
• Experience as technical lead on industry–academic collaborations or sponsored research agreements Please submit cover letter and resume

Education Qualifications

Bachelor's (Required), Master's

Experience

Interview Requirement

Interview

Requirements

Any candidate who is called for an interview must notify the Department of Equal Opportunity/Regulatory Compliance in writing of any reasonable accommodation needed prior to the date of the interview.

EEO Statement

The University of Mississippi provides equal opportunity in any employment practice, education program, or education activity to all qualified persons. The University complies with all applicable laws regarding equal opportunity and does not unlawfully discriminate against any employee or applicant for employment based upon race, color, gender, sex, pregnancy, sexual orientation, gender identity or expression, religion, national origin, ethnicity, citizenship, age, disability, military status, protected veteran status, genetic information, or any other legally protected status.

Background Check Statement

The University of Mississippi is committed to providing a safe campus community. UM conducts background investigations for applicants being considered for employment. Background investigations include a criminal history record check, and when appropriate, a financial (credit) report or driving history check.

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