The Senior R&D Engineer role is responsible for designing, developing, validating, and implementing various methods and processes, leading and assisting in projects to introduce new products into production. This role is expected to bring unique perspectives and creative solutions to challenges faced during reverse engineering and reprocessing technique development.

Essential Duties and Responsibilities:
• Assist and/or lead in development of new medical device platforms complying with design control process including applicable FDA and ISO requirements.
• Develop, write, and execute test methods.
• Train manufacturing/QC personnel as needed on test methods or manufacturing processes.
• Generate formal test protocols and reports.
• 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.
• Use Solidworks to design test fixtures and devices. (if applicable)
• Design and fabricate test fixtures, tooling and equipment. (if applicable)
• Work with purchasing department to specify and procure capital equipment.
• Serve as a cross-functional team member for various project-related activities.
• Assist or lead process improvement projects to reduce costs.
• Assist with DFMEA and PFMEA risk assessments.
• Compile project status updates and present to senior management.
• Comply with company policies and procedures.
• Maintain project schedule and deliver projects on time.
• Focus on delivering products to support the R&D project pipeline.
• Provide technical leadership to junior engineers and technicians.

Clinical Support Responsibilities:
• Attend clinical cases for learning, device launch, and troubleshooting.
• Interact with clinicians and field personnel to understand clinical needs and provide technical support.
• Develop and maintain a deep understanding of medical device reprocessing techniques, including cleaning, sterilization, and biocompatibility requirements.
• Develop and maintain relationships with key opinion leaders and clinical partners.

Medical Device Reprocessing Responsibilities:
• Develop and optimize reprocessing methods for single-use medical devices.
• Conduct performance, biocompatibility and sterilization testing on reprocessed devices.
• Ensure compliance with all regulatory requirements for medical device reprocessing.
• Participate in cross-functional teams to introduce reprocessed devices into production.

Supervisory Responsibilities:
• Provide mentoring and guidance to other R&D team members, as well as supervise and manage the work of junior engineers.

Education, Qualifications and Skills:
• Minimum education: Bachelor's degree in engineering discipline (or equivalent experience)
• Minimum experience: 7-12 years of experience
• Strong background in R&D with experience in electromechanical medical devices.
• Experience with various types of medical device design verification testing in accordance with FDA regulations: device functional performance, biocompatibility, sterilization, packaging, transportation simulation, real-time and accelerated aging, etc.
• Excellent technical writing skills and substantial experience writing test plans, protocols, and reports.
• Excellent problem-solving skills as well as keen analytical abilities.
• Knowledge of Design Controls, Risk Management, Statistics, Engineering Principles, Test Method Development, Test Method Validation (Gage R&R), and Design Verification / Validation.
• Proficiency in CAD design and drafting (SolidWorks) a plus.
• Ability to work in a fast-paced, collaborative team environment.
• Strong hands-on prototyping skills.
• Self-starter and highly motivated.
• Ability to have fun by motivating and encouraging other team members.