Medical Device Engineer

Senior Medical Device EngineerThe Science Team at Pride Health supporting the Pharmaceutical Industry has an opening for a Senior Medical Device Engineer in San Diego, CA. Position Summary: We are seeking a Senior Medical Device Engineer to join our Research & Development team. In this role, you will collaborate with scientists, engineers, Quality, Manufacturing, and Regulatory teams to develop, optimize, and validate innovative material designs for medical device applications. You will play a key role in supporting product development through hands-on laboratory work, technical documentation, qualification and validation activities, and cross-functional collaboration.Additional Details:Contract Length: 06 Months with the possibility of extensionsPay range: $60 to $70 per hour on W2 (As per experience)Responsibilities:Develop and optimize polymer membrane formulations and material solutions for medical device applications.Plan, execute, and analyze laboratory experiments to support product and process development.Generate, review, and maintain technical documentation including protocols, reports, SOPs, work instructions, and design control documentation.Support qualification and validation activities, including IQ, OQ, PQ, method validation, verification, and process validation.Collaborate with cross-functional teams including R&D, Quality, Manufacturing, Regulatory Affairs, and external suppliers.Identify, procure, and qualify raw materials to support product development and commercialization.Perform risk assessments and support design control activities throughout the product development lifecycle.Analyze experimental data using statistical tools and Design of Experiments (DOE) methodologies to drive technical decisions.Ensure compliance with FDA regulations, ISO 13485, GxP requirements, and internal quality standards.Support commercialization efforts and continuous improvement initiatives.Follow laboratory safety procedures, chemical hygiene practices, and environmental health and safety requirements.Required Qualifications:Bachelor's degree in Materials Science, Polymer Science, Chemical Engineering, Biomedical Engineering, Chemistry, or a related engineering or scientific discipline.Minimum of 5–7 years of experience in medical device development, materials science, polymer science, biosensor development, or a related field.Strong understanding of polymer materials, formulation development, and laboratory experimentation.Experience with technical writing and Good Documentation Practices (GDP).Experience supporting design controls, qualification, and validation activities in a regulated environment.Working knowledge of FDA Quality System Regulations, ISO 13485, and GxP requirements.Experience with statistical analysis and DOE methodologies; JMP experience is preferred.Proficiency with Microsoft Office applications.Excellent written and verbal communication skills.Strong analytical, organizational, and problem-solving abilities.Ability to work effectively in a fast-paced, collaborative environment.Preferred Qualifications:Experience with Class III medical devices or biosensor technologies.Knowledge of risk management and product development lifecycle documentation.Experience with supplier qualification and raw material selection.Project management experience is a plus.Must be authorized to work in the United States. Russell Tobin offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.Russell Tobin is a leading minority-owned professional and technical recruitment and staffing advisory organization. We are comprised of specialized practices focusing on a variety of skill sets and industries. Having a depth and breadth of industry expertise, our subject matter experts are able to provide tailored and swift sourcing solutions to fulfill client hiring needs. In other words, we connect top talent with companies. We are the staffing arm of the Pride Global network, a minority-owned integrated human capital solutions firm, with additional offerings in vendor management, payroll programs, and business process optimization. As a certified minority-owned business, Pride Global and its affiliates - including Russell Tobin, Pride Health, and Pride Now - are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics.