Rsch Pro 5-Rsch Translation

Rsch Pro 5-Rsch Translation University of Minnesota - 4.1 Minneapolis, MN Job Details Full-time 2 hours ago Qualifications FDA submissions Laboratory experiment design Business development management Product development project management Quality management standards in production Requirements design Startup experience Design of experiments Academic institution experience Research project design Requirements analysis Fundraising Engineering research Regulatory affairs Product design Engineering product development Biomedical regulatory compliance Managing projects Business development within technology Business development within healthcare Biomedical manufacturing processes Healthcare industry grant writing Translational research Prototypes Healthcare research Cross-functional communication Full Job Description Required qualifications include: BA/BS degree plus at least six years of relevant experience, or advanced degree plus at least four years of relevant experience. Relevant experience includes experience in medical device development within a medical device company, startup, or academic setting. Proven track record in technology commercialization and translational research, preferably with experience in medical device innovation and university-to-market translation. Hands-on experience with startup formation, including developing product specifications, customer discovery, and fundraising. Proficient in experimental design, prototyping, and wet lab techniques. Demonstrated ability to integrate R D with business development, regulatory, and clinical strategies. Experience with federal grant writing and navigating regulatory pathways. Experience defining quality requirements and establishing quality management systems. Prior experience in developing regulatory strategies and navigating programs like the FDA -Emerging Technologies Program. Strong collaborative skills with the ability to work across interdisciplinary teams. Excellent project and time management skills, with a proactive approach to problem-solving. Familiarity with the Biodesign innovation process or similar methodologies is a plus.

Preferred qualifications include:

Advanced degree (PhD/MS or MD) in biomedical engineering, chemical engineering, mechanical engineering, or a related field. At least 5 years of experience in medical device development within a medical device company, startup, or academic setting. Familiarity with dialysis systems or the renal care space is highly desirable. About the Job The Researcher will bridge the gap between scientific research and commercialization, providing expertise, support, and training to facilitate the translation of research findings into real-world application. This position requires an innovative leader with a blend of R D expertise, business development acumen, regulatory insight, and clinical development experience. You will be responsible for maturing our IP portfolio by developing robust product specifications, executing a comprehensive product development roadmap, securing key supplier/vendor relationships, and spearheading regulatory strategies—most notably, working toward inclusion in the FDA Emerging Technologies Program (ETP). You will develop and manage partnerships and collaborations with researchers, community organizations, and industry partners to identify research priorities and opportunities for translation of research findings into practical application, including assisting with federal translational grant applications. Duties/responsibilities IP and Product Advancement (20%): Advance and mature the intellectual property portfolio for decentralized, point-of-care manufacturing of dialysis and other medical fluids. Translate laboratory research into viable, scalable product concepts ready for commercialization. Strategic Planning & Roadmapping (10%): Define the available market opportunity through extensive customer discovery interviews and market analysis. Develop comprehensive product specifications and a detailed product development roadmap (using tools such as Microsoft Projects or similar platforms). Grant Writing and Development (20%): Prepare and execute federal grant submissions (e.g., NSF Fast-Track) and assist in developing fundraising materials (pitch decks, data room, etc.). Supplier & Vendor Engagement (10%): Identify, evaluate, and secure relationships with necessary suppliers and vendors to meet product development milestones. Regulatory Strategy (10%): Design and implement a regulatory strategy aimed at qualifying for programs like the FDA Emerging Technologies Program (ETP). Define quality requirements and establish a Quality Management System (QMS). Cross-Functional Collaboration (5%): Work closely with R D, regulatory affairs, clinical development, and business development consultants within and outside the UMN Discovery Launchpad. Collaborate with the UMN Tech Commercialization to support technology transfer processes. Clinical Trial Design (25%): Participates in clinical research project design, implementation and monitoring. Plan for, collectors, screens, and summarizes information gathered from clinical trials. Makes certain that reported clinical trial data is complete and accurate. The Department of Mechanical Engineering has an internationally recognized faculty, and is part of the College of Science and Engineering, the highly interdisciplinary college of engineering, physical sciences, and mathematics. Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume. Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section. To request an accommodation during the application process, please e-mail or call (612) 624-8647. The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds. The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the

U:

http://diversity.umn.edu Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment. The University of Minnesota, Twin Cities (UMTC) The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations. At the University of Minnesota, we are proud to be recognized by Forbes as a Best Employer for Company Culture (2026), Best Employer for Women (2023), and Best Employer by State (2022-2026). In 2026, we also received Culture Excellence & Industry Awards recognition for employee appreciation and work-life flexibility.