The R&D Engineer II is responsible for providing comprehensive engineering support throughout the lifecycle of medical device development projects. From initial design through to production, this role ensures adherence to established design controls, regulatory requirements, and industry standards. The R&D Engineer II collaborates cross-functionally with multidisciplinary teams to drive innovation, optimize product performance, and ensure compliance with relevant regulatory guidelines. Essential Duties and Responsibilities: · Lead and/or assist development of new medical device platforms complying with design control process including applicable FDA and ISO requirements. · Design, investigate, develop and qualify new manufacturing processes, fixtures and equipment. · Write test protocols and reports, conduct various testing, collect and analyze data and trends. · Perform sustaining, development, analysis, evaluation, testing and troubleshooting of finished devices, electrical systems (when applicable) and their respective components, sub-assemblies and test fixtures. · Train manufacturing/QC personnel as needed on test methods or manufacturing processes. · Execute test protocols and conduct bench testing. Document test results per GDP, ISO and FDA requirements. · Coordinate and oversee test sample builds. Assist with test sample builds as required. · Develop, qualify and update engineering documents such as manufacturing instructions, drawings, FMEA's and test methods. · Coordinate the design and fabrication of test fixtures, tooling and equipment. (if applicable) · Work with purchasing department to specify and procure capital equipment. · Serves as an external cross function team member for various project related activities as well as supporting R&D projects at group level participating in meetings and sharing technical information and "best-practices". · Assist or lead process improvement projects to reduce costs. · Complies with company policies and procedures. · Maintains project schedules while focusing on delivering products to support the R&D project pipeline. · Ensure that program objectives are determined and met, logistics are effectively coordinated and budgets are adhered to. · Actively searches for best-in-class technologies among competitors and develops innovation roadmap. · Maximizes product profitability and improve product performances. · Perform root cause analysis, propose and implement corrections and corrective actions. · Collaborate with the Production team to identify capabilities and capacity. · Support R&D Franchise goals through project or franchise leadership, define and lead system or process efficiencies, early-stage people management by mentoring and directing interns and or junior engineers. Supervisory Responsibilities: · Supervise and manage R&D Interns relating to project specific tasks. · Provide guidance and technical information for Interns. Education, Qualifications and Skills: · Bachelor's degree in engineering (or other related degree) with three years related engineering experience or a minimum of six years unrelated experience. · Ability to work in a fast paced, collaborative team environment. · Ability to understand CAD drawings. · Knowledge of Geometric Dimensioning and Tolerancing (GD&T). · Strong hands-on prototyping skills. · Ability to coordinate test sample builds. · Ability to write technical documents (procedures, test methods, protocols and reports). · Ability to execute protocols and conduct data analysis. · Ability to train manufacturing/QC/technicians. · Ability to work with little supervision. · Ability to use personal computers including software such as: Word, PowerPoint, Excel, and Minitab. · Self-starter and highly motivated. · Ability to have fun by motivating and encouraging other team members. Work Environment: · This job operates in a clerical, office, as well as a manufacturing setting. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. · While performing the duties of this job, the employee is frequently exposed to odors, fumes, dust or airborne particles, moving mechanical parts and vibration. The noise level in the work environment and job sites can be loud. · The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. · While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms. · The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.