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

Our mid-sized client is adding a passionate and high-energy Director of Business Development to expand their national footprint. If you're a proven closer with a strategic mindset, experience in Urology, and a strong grasp of partnership contracts — we want to talk to you. Our client provides state-of-the-art mobile healthcare services focused on advanced urology technologies — including shockwave lithotripsy (ESWL), laser lithotripsy (URS), and MR fusion biopsy. Their model is innovative, cost-effective, and deeply

 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

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

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

Our science-driven medical device client is redefining expectations and advancing the field through cutting-edge solutions and therefore hiring a Sr. Director of Regulatory Affairs. The Sr. RA Director reports to the SVP of Clinical and Regulatory Affairs and will support the strategic direction, as well as lead the day-to-day execution of global regulatory activities. This role will be responsible for preparing high-quality regulatory submissions, supporting interactions with the FDA and other international regulatory bodies, and

Our clinical-stage startup medical device company is executing two clinical studies to support a panel-track PMA device treatment for uncontrolled hypertension.  The Clinical Research Associate will assist in executing these two randomized, double-blinded studies in collaboration with the Sr. Clinical Program Manager and Chief Clinical Officer. The CRA will work with CROs to support the PMA approval of the Class III device and execution of the clinical study.   Your role with the company:   Site support for the

Our start-up, clinical-stage medical device client, is adding a 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 accountability

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

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 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 coordinate

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

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

Our mid-sized medical device client is adding a Sr. Clinical Research Associate to the team. The Sr. CRA is responsible for initiating and overseeing clinical centers to ensure the successful conduct of active clinical studies. The Sr. Clinical Research Associate will ensure that clinical centers perform the clinical study according to the study protocol and regulatory standards by qualifying, training, monitoring, and overseeing study conduct at multiple clinical centers. Your role with the company: Identify and assess the suitability

Our small start-up client is adding (Sr.) Clinical Research Associates (CRA) to the team. The CRA works as part of the clinical team to ensure the completion of company-sponsored clinical studies.  As an internal and externally facing position, this position interacts directly with the internal study team, clinical vendors, clinical Investigators, and other study staff at a clinical research site.  The CRA will be the primary contact for the study sites regarding the proper execution of the clinical

Our mid-sized medical device client is looking for a seasoned engineer. The Product Development Engineer III with a mechanical focus, is responsible for development and implementation of new products, developed jointly with Process Development and Manufacturing Engineering, into full production, as well as supporting of continuation engineering on existing product lines. The role will be about 70% Project Management with about 30% technical. Your role with the company: Product Concept: *Basic understanding of customer/user and patient needs. *Proposes concepts