Job Description Job Overview We are seeking an R&D Engineer to support the design, development, testing, and commercialization of innovative medical device products. This role will be responsible for hands-on engineering activities throughout the product development lifecycle, including concept development, mechanical design, prototyping, design verification, testing, documentation, and manufacturing support. The ideal candidate has a strong mechanical engineering background, experience with CAD and product development, and the ability to independently execute technical assignments while collaborating effectively with R&D, Quality, Regulatory, Operations, and Manufacturing. This position is well suited for an engineer who enjoys solving technical problems and translating product requirements into practical, manufacturable designs. Responsibilities Design and develop medical devices, instruments, components, and related products from concept through design transfer and commercialization. Create and revise 3D models, engineering drawings, assemblies, and design documentation using SolidWorks or similar CAD software. Apply mechanical engineering principles, GD&T, tolerance analysis, material selection, and Design for Manufacturing (DFM) principles to product designs. Develop prototypes and evaluate design concepts through hands-on testing, measurement, and analysis. Plan and execute engineering studies, feasibility testing, design verification activities, and product performance evaluations. Develop test methods, protocols, fixtures, and equipment necessary to evaluate product performance and design requirements. Analyze test data and document results through engineering reports, test reports, and other technical documentation. Perform root cause analysis and troubleshooting of design, manufacturing, and product performance issues and support the development of appropriate corrective actions. Support risk management activities, including identification of potential design and product risks and implementation of appropriate risk controls. Participate in design reviews and provide technical input throughout the product development process. Support design control activities and preparation of documentation required for the Design History File (DHF). Work closely with Quality and Regulatory teams to ensure designs and development activities meet applicable requirements and standards. Collaborate with suppliers and contract manufacturers to support prototype development, manufacturing processes, tooling, and production readiness. Evaluate first articles, prototypes, and production components for dimensional and functional compliance with engineering requirements. Support design transfer activities, including manufacturing documentation, inspection requirements, specifications, and production implementation. Initiate and support engineering changes, drawing revisions, and product/process improvements. Maintain accurate and organized engineering records, specifications, drawings, test data, and project documentation. Manage assigned engineering tasks and projects to established timelines while communicating technical issues, risks, and progress to project stakeholders. Provide technical support for existing products and continuous improvement initiatives as needed. Experience & Qualifications Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline. Experience in product development, mechanical design, R&D, or a related engineering environment. Proficiency with SolidWorks or comparable 3D CAD software. Strong understanding of mechanical design principles, engineering drawings, tolerancing, and GD&T. Hands-on experience with prototyping, mechanical testing, measurement equipment, and engineering evaluation. Ability to interpret technical drawings, specifications, and product requirements. Experience performing root cause analysis and solving mechanical or manufacturing-related technical problems. Strong technical documentation skills with the ability to clearly document engineering rationale, test methods, results, and conclusions. Ability to independently manage engineering assignments while working effectively within a cross-functional team. Strong analytical, organizational, and problem-solving skills. Effective written and verbal communication skills. Preferred Qualifications Experience in the medical device industry, particularly orthopedic, spinal, or surgical devices. Familiarity with medical device design controls and product development requirements. Experience with

ISO 13485, FDA

Quality System requirements, and applicable medical device standards. Experience with design verification and validation activities. Experience with risk management principles, including

ISO 14971.

Experience working with machined components, surgical instruments, implants, or precision mechanical assemblies. Knowledge of common manufacturing processes such as CNC machining, additive manufacturing, injection molding, and finishing processes. Experience working directly with suppliers and contract manufacturers. Experience with 3D scanning, inspection equipment, test fixtures, or other engineering laboratory equipment. Familiarity with statistical analysis or engineering data analysis tools is a plus. Benefits 401(k) Dental insurance Health insurance Paid time off Vision insurance

Work Location:

In person

Pay:

$110,000.00 - $130,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Health savings account Paid time off Retirement plan Vision insurance

Work Location:

In person