Job Title: R&D Engineer Job Description This position supports the design and development of product changes within sustaining engineering and new product development for disposable medical devices. The role requires expertise in medical device design, focusing on Class II and Class III disposable products. Responsibilities + Design and develop product modifications and innovations within sustaining engineering projects. + Lead new product development initiatives for disposable medical devices. + Ensure compliance with FDA Design Controls and ISO Quality Management Systems. + Apply risk management practices as per ANSI/AAMI/ISO standards in medical device development. + Collaborate with cross-functional teams to optimize product design and functionality. Essential Skills + Bachelor's degree in Mechanical, Plastics, Biomedical Engineering, or a related field; Master's degree preferred. + Minimum of 5 years of experience in Class II or Class III disposables medical product development. + Proficiency in Design for Six Sigma (DFSS) principles. + Strong knowledge of plastics materials and processing, including injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization. + Proficiency in CAD design and PDM enterprise software, such as Creo and Solidworks. Additional Skills & Qualifications + Certification in Design for Six Sigma (DFSS) is highly desirable. + Experience with FDA Design Controls and ISO Quality Management Systems. + Familiarity with ANSI/AAMI/ISO standards related to medical device risk management. Work Environment The position offers a hybrid work environment, allowing remote work on Mondays and Fridays, with in-office presence required on Tuesdays, Thursdays, and Fridays. Core working hours are from 9 AM to 3 PM. Pay and Benefits The pay range for this position is $88000.00 - $130000.00/yr. Eligible for 5% annual bonus based on individual and company performanceAnnual Merit increases 401k 4% Match10 Paid HolidaysPTO Workplace Type This is a hybrid position in Minneapolis,MN. Application Deadline This position is anticipated to close on Aug 13, 2025. About Actalent Actalent 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. The 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 due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.