Custom Search Inc.
Sr. Manufacturing Quality Engineer
11/21/2025
Maple Grove, MN
Direct HireOn-Site
Our mid-sized medical device client is adding a Senior Manufacturing Quality Engineer to join their growing team. This is a critical role focused on leading our validation and verification efforts as they pursue ISO 13485, EU MDR, and CE Mark certifications. If you are a hands-on quality professional with a strong background in medical device manufacturing and a desire to make a significant impact, this is the role for you. Your role with the company: Lead and execute
Clinical Training & Education Manager/Director
11/19/2025
Minneapolis, MN
Direct Hire
We’ve partnered with an innovative structural heart start-up that’s transforming treatment options for patients with structural heart disease. They’re adding a Clinical Education & Training Manager/Director to elevate how physicians and internal teams learn, train, and deliver life-changing care. This is an incredible opportunity to build something from the ground up — designing scalable, high-impact training for interventional cardiologists, echocardiologists, anesthesiologists, and clinical teams across the U.S. and abroad. If you’re passionate about improving
Quality/Regulatory Affairs Specialist
11/17/2025
Eden Prairie, MN
Direct HireOn-Site
We have partnered with a small start-up company that is looking for someone who’s hungry to grow, ready to learn, and excited to be at the center of product quality and regulatory excellence. In this role, you’ll be the bridge between engineering, manufacturing, quality, and regulatory teams, helping ensure their devices meet the highest standards and are ready for global markets. If you love variety, impact, and being part of a company that’s building meaningful technology
Sr. Clinical Evidence Project Manager
11/17/2025
Minneapolis, MN
Direct HireHybrid
Our mid-sized medical device client is adding a Senior Clinical Evidence Project Manager. The Project Manager will be responsible for the strategic management and oversight of all aspects of the Clinical Trial Team activities for assigned projects in accordance with the relevant standards as well as companies standard operating procedures. The Senior Clinical Evidence Project Manager, in collaboration with Clinical Program Managers and senior leadership, is accountable for achieving successful delivery of Clinical Team activities at the project level
Sr. R&D Engineer
11/17/2025
Minneapolis, MN
Direct HireOn-Site
Our mid-size cardiovascular client is adding a Senior R&D/Product Development Engineer to the team. The Engineer will lead product development activities from concept to commercialization. Your role with the company: Lead conceptualization, design and development of new devices or elements of new devices with the intent of commercialization per Quality System Requirements Acts as leader and/or primary technical contributor for cross-functional development team(s) that manage projects from concept through commercialization. Accurately and efficiently translates user
Sr/Principal Regulatory Affairs Specialist
11/13/2025
Minneapolis, MN
Direct HireOn-Site
Our science-driven client is redefining expectations and advancing the field through cutting-edge solutions. The RA team is adding a Sr/Principal Regulatory Affairs Specialist to the team. The RA Specialist will report to the Sr. Director of RA and will lead and execute regulatory submission and approval activities for the company’s medical device products, with a primary focus on U.S. FDA submissions. This role will also provide support for international regulatory submissions outside North America. The Specialist will
Sr. Regulatory Specialist
11/13/2025
Maple Grove, MN
Direct Hire
Our start-up client is developing breakthrough medical technologies and and they’re adding a Senior Regulatory Affairs Specialist to help bring these innovations to patients worldwide. In this role, you’ll own key regulatory activities that drive U.S. and global submissions, ensure compliance, and keep products aligned with evolving FDA and EU MDR requirements. You’ll collaborate closely with engineering and clinical teams, shaping strategy and ensuring documentation is accurate, complete, and compliant. You're role with the company
Clinical Trial Assistant
11/13/2025
Plymouth, MN
Direct HireOn-Site
Our clinical-stage medical device company is adding a Clinical Trial Assistant to the team. This position represents an exciting opportunity to make an impact in early stages of clinical development for an innovative technology. As a member of the field team, the Clinical Trial Assistant is a professional who provides administrative support to clinical trials. Their primary role is to assist clinical research professionals, such as clinical research coordinators, study managers, and investigators, with the daily tasks involved in
(Sr) Clinical Research Associate
11/13/2025
Plymouth, MN
Direct HireHybrid
Our start-up, clinical-stage medical device client, is adding a (Sr) Clinical Research Associate to the team. The CRA will support operational activities related to the organization's sponsored clinical research programs. Primary responsibilities will be the start-up and management of assigned clinical sites and task and projects related to the preparation and administration of US and OUS clinical trials, including (but not limited to) the development of study materials, site training materials, clinical quality system documents, device
Principal R&D Engineer
11/13/2025
Eden Prairie, MN
Direct HireOn-Site
Our mid-size cardiovascular client is adding a Principal R&D/Product Development Engineer to the team. The Engineer will lead product development activities from concept to commercialization. Your role with the company: Lead conceptualization, design, and development of new devices or elements of new devices with the intent of commercialization per Quality System Requirements Acts as leader and/or primary technical contributor for cross-functional development team(s) that manage projects from concept through commercialization. Accurately and efficiently translates user
Production Supervisor (3rd shift)
11/13/2025
St. Paul, MN
Direct Hire
Our mid-sized medical device client is recruiting for a Production Supervisor. The Production Supervisor will play a pivotal role in overseeing daily operations within manufacturing processes and ensuring adherence to policies and procedures. Your responsibilities will include developing people and processes to optimize safety, quality, productivity, and timely delivery. This role requires a blend of forward-thinking and hands-on leadership to drive operational excellence. Your role with the company: Lead assigned operations team in delivering results across the
Principal Design Assurance Engineer
10/28/2025
Minneapolis, MN
Direct Hire
 Our start-up medical device client is adding a Design Assurance Manager to the team. The DA Manager works cross-functionally and is responsible for providing Design Assurance representation on teams, facilitating design verification and validation for transfer to manufacturing, and implementing process/product improvements. The manager also supports quality management system process development and execution for applicable processes. The role has shared responsibility for product safety and quality in all stages of product and process development, and ensuring compliance with
Design Assurance Manager
10/21/2025
Minneapolis, MN
Direct HireOn-Site
  Our mid-sized medical device client is adding a Design Assurance (DA) Manager to the team. The DA Manager will be responsible for providing quality engineering support for all phases of product development, driving post-market assessment activities, and supporting consistent design through production release and commercialization. Your role with the company: Responsible for ensuring staffing and successful execution for all projects assigned to the DA team. Serve as a working team member in the execution of product development process
Manufacturing Program Manager
9/29/2025
St Paul, MN
Direct HireOn-Site
Our mid-sized medical device client is building a Program Management department. The Manufacturing Program Manager will oversee New Product Introductions, Capacity initiatives, and Transfer Programs. This role will work closely with plant leadership, quality, and the R&D group to create and establish a framework for oversight and management of NPI, Capacity Initiatives, and Transfer programs at manufacturing sites. This role works with internal and external customers, and technical resources are available to ensure effective execution of programs

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