Our small start-up client is adding a Clinical Study Manager to the team. Are you ready to join a supportive company developing a novel neuromodulation device, and to help build the clinical research infrastructure? They are growing the Clinical Affairs team (2nd person in clinical) with the addition of a (Senior/Principal) Clinical Study Manager . This role is filled with growth opportunities and has responsibility to execute clinical development plans for a novel neuromodulation platform technology. Key job aspects include

Our mid-sized medical client is adding a Sr. Regulatory Affairs Specialist to their team! The Sr. Regulatory Specialist will support international registrations and renewals as well as PMA work . This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed.  The Regulatory Affairs Specialist will perform regulatory submission/approval activities for specific products and ensures compliance with required regulations and established corporate standards. Your role with the company: Prepare documentation for international regulatory

Our mid-sized medical device is building a continuous improvement team and adding a Sr. Continuous Improvement Manager/Director. The Manager/Director will drive continuous improvement initiatives across engineering operations by providing supervision and technical leadership to employees and supervisors in the department. The Sr. Continuous Improvement Manager/Director is responsible for analyzing, designing, and implementing manufacturing and business process improvements that increase capacity, reduce lead-time, reduce the work-in-process, improve fill-rates, and improve process flow and efficiency. Your role

Our mid-sized medical device client is adding a Sr. Production Manager to the team. The Senior Production Manager will oversee all daily operations from assembly and fabrication to ensuring policies and procedures are followed facility. This role is responsible for developing people and processes that will maximize safety, quality, productivity, and on-time delivery. The Senior Production Manager leads the execution of the business strategy to accomplish corporate objectives and plans for a singular facility. This role requires a

Our mid-sized medical device client is adding a Sr/Clinical Research Associate to the team. The Sr. CRA is responsible for the initiation and oversight of 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

Our mid-sized medical device client is adding a Sr. Design Assurance Engineer to the team! The Sr. Design Assurance Engineer utilizes risk management and quality planning activities to provide quality engineering support of product/process development and input to Quality Management Systems affecting product/process development. Champions departmental or cross-functional engineering initiatives and acts as an effective leader or team member in supporting quality disciplines, decisions and practices. Your role with the company: Key member of medical device development project

Our smaller medical device client is adding a Director of Electrical and Software Engineering to lead an engineering team in creating groundbreaking solutions. The Director of Electrical and Software Engineering will play a pivotal role in driving the development and implementation of electrical and software systems for innovative medical devices. This leadership position requires a seasoned professional with a proven track record in both electrical and software engineering, as well as a deep understanding of regulatory requirements within the medical

Our mid-sized medical device client is adding a Senior Quality Engineer to the team! The Sr. QE will have the opportunity to be a key team member in supporting a medical device from transfer to manufacturing through commercial distribution. They are responsible for ensuring a smooth transition of new products to the manufacturing floor with the assistance of a cross-functional team. They will maintain oversight of all manufacturing activities and be responsible for the final release of sterile

Our mid-sized medical device client is adding a Clinical Study Manager to the team! The Clinical Study Manager will report to the Sr. Clinical Manager and will oversee clinical activities related to one or more clinical studies and performing/managing the daily in-house operations associated with the studies. The Clinical Study Manager will work independently on multiple complex clinical studies using critical thinking skills. Will be managing one study in start-up and another on-going study. The new

Our mid-sized client is adding a Regulatory Affairs Specialist 2 to join their team. The Regulatory Affairs Specialist will support international registrations and renewals. This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed.  The Regulatory Affairs Specialist will perform regulatory submission/approval activities for specific products and ensures compliance with required regulations and established corporate standards.   Your role with the company:   Preparing documentation for international regulatory registrations and renewals. Defining worldwide