Now Hiring an R&D EngineerPay : $104k-140k/yearLocation: Must be local to the state of MinnesotaJob Description:Looking for an R&D Engineer that has a strong focus within sustaining existing product lines. This individual will be working on disposable medical devices. They will be focused on the design development, product changes and budget let technology on their current product line that is on the market. Majority of the role will be the maintenance of products.Key Responsibilities:-Schedule, budget and leading engineering projects steaming from customer changes, complaints, and supplier changes among other things-Be the technical expert for design change programs, working with new materials or products, new suppliers, materials, labeling and CAPA/NCR, cost reduction and remediation efforts-Completing Root-Cause analyst, FMEA, CAPAs-Responsible for creating and maintenance of design history files-Manage design control procedures, general safety rules, company policies and procedures and over see FDA regulation and guidanceSkills & Qualifications:-R&D Engineering within Sustaining 5+ years of experience-5+ years of working within the medical device industry-5+ years of working with disposable devices ideally plastic materials-Advanced knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.-Advanced knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.Working knowledge of CAD design and PDM enterprise software (e.g. Creo, Solidworks).Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.About ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:Hiring diverse talentMaintaining an inclusive environment through persistent self-reflectionBuilding a culture of care, engagement, and recognition with clear outcomesEnsuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email (% ) for other accommodation options.