R&D Engineer III -Medical Device- #6845

Location Maple Grove, MN,Maple Grove, MN, 55311,United States Employee Type Contractor or FT Employee Required Degree 4 Year Degree About ECI ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry. About the Role The R&D Engineer III will contribute to integration-focused development and design activities. This role requires solid technical fundamentals, working knowledge of design controls and risk management execution, and the ability to perform a range of assignments with a moderate level of guidance while collaborating with cross-functional partners to deliver high-quality product solutions. What You’ll Do Support acquisition integration workstreams to incorporate new technologies the client's systems and processes; contribute to interface definition, requirements alignment, integration planning, and technical decision-making for assigned deliverables. Develop and deliver design control outputs (user needs, design inputs/outputs, traceability, risk management, verification/validation, and DHF documentation) in accordance with relevant standards, regulations, and internal procedures. Conduct feasibility studies, develop prototypes, and plan/execute testing to optimize product designs and support integration readiness across multiple device models and iterations. Investigate failure modes, perform root cause analyses, and implement solutions to technical and quality challenges; identify integration risks and support mitigation plans with cross-functional partners. Work closely with cross-functional and multi-site teams, including quality, manufacturing, supplier engineering, and regulatory affairs, to support successful integration execution, timely deliverables, and clear communication of technical information. What We Look For BS or above in Mechanical Engineering, Biomedical Engineering, or related field 4+ years of engineering experience with a Bachelor’s degree or 2+ years with an advanced degree 2+ years of experience with Medtech device design and development in a design controls environment Experience with catheter and/or single-use medical device design and development Working knowledge of design controls, risk management, and documentation (e.g., requirements, traceability, verification/validation, DHF, change control) Previous experience supporting product, subsystem, or system integrations Strong technical knowledge, problem-solving abilities, collaborative mindset, and effective communication skills; able to exercise judgment using practical experience and prescribed guidelines Previous experience with product acquisition integration and/or technology/platform integration Personal drive, individual accountability, and a strong bias for action; independent critical thinker Comfortable working in ambiguity; adaptable and agile in response to evolving priorities Hands-on experience with balloon catheter and/or catheter system product development for single-use devices Class II or Class III medical device product development experience and regulatory requirements ECI is an equal opportunity employer. All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity. #J-18808-Ljbffr Theuniversityunion