Senior R&D Engineer

Senior R&D Engineer - Medical Devicesð Are you passionate about designing products that improve lives? We're partnering with an innovative medical device organization seeking a Senior Product Development Engineer to support sustaining engineering initiatives for Class II and III disposable medical devices.This is an opportunity to work on meaningful products, collaborate with global cross-functional teams, and drive engineering solutions from concept through implementation in a highly regulated environment.What You'll DoAs a Senior R&D Engineer, you will lead and support engineering projects focused on product improvements, compliance, quality, and performance enhancements. Responsibilities include: Leading small to medium-sized projects involving:Product enhancements and new featuresSupplier and material changesLabeling updatesCAPA/NCR activitiesCost reduction initiativesProduct remediation efforts Identifying and solving complex engineering challenges using risk-based and customer-focused methodologies Developing and maintaining technical documentation, including:Design specificationsEngineering drawingsValidation protocols and reportsProduct labeling documentation Planning and executing:Verification & Validation (V&V)Product testingTest method validations Building prototypes and supporting fixture/tooling development for product evaluation and manufacturing support Ensuring compliance with FDA regulations, ISO standards, design controls, and quality system requirementsWhat We're Looking Forð QualificationsBachelor's degree in Mechanical Engineering, Biomedical Engineering, Plastics Engineering, or a related discipline3+ years of experience developing or supporting Class II and/or Class III medical devicesExperience with disposable medical product design and sustaining engineering activitiesð Technical ExpertisePlastics processing technologies including injection molding, extrusion, ultrasonic welding, bonding processes, and sterilization methodsCAD and Product Data Management (PDM) platforms such as Creo or SolidWorksFDA Design Controls and ISO 13485 Quality Management SystemsRisk Management practices aligned with ISO 14971ð Professional AttributesSelf-starter with a strong sense of ownership and accountabilityInnovative mindset with a passion for continuous improvementStrong communication and cross-functional collaboration skillsHighly organized with excellent attention to detailAbility to manage multiple priorities in a fast-paced environmentWhy This Opportunity?You'll join a team focused on delivering high-quality medical device solutions that make a real difference for patients and healthcare providers worldwide. If you enjoy solving complex engineering challenges, driving product improvements, and working in a collaborative environment, we'd love to connect.EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.To find out more about Real, please visit