Our structural heart start-up client is adding a Travel Logistics Coordinator who will act as the administrative and operational liaison between the clinical field team and company headquarters. In this role, the Travel and Logistics Coordinator is responsible for coordinating all case logistics (domestic and international) including but not limited to: ongoing communication with study sites, booking travel, accommodations, ground transportations, booking various venues and reservations as necessary. This position will be compliant and knowledgeable of current TSA requirements

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 mis-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

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 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 smaller medical device client is adding a Sr or Principal Systems Engineer to the team! The engineer  will provide interdisciplinary research and product development leadership from inception through pilot production through commercial launch.   He or she must be able to work effectively with all functional groups to define system-level requirements and resolve cross-functional issues. Success in this position relies heavily on meeting dates and maintaining accountability while using experience and judgement to develop products and meet goals

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 client is adding a Sr/Principal Regulatory Affairs Specialist to their team! The Sr/Principal 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: Prepare documentation for international regulatory registration Prepare technical documentation compliant to

Our mid-sized medical device is building a continuous improvement team and adding a Sr. Continuous Improvement Manager. The manager 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 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 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 Sr. Sustaining Engineer to the team. This is a newly created position reporting to the Director of Quality. The Sr. Sustaining Engineer will be primarily maintaining existing commercialized products post transfer by ensuring the products remains safe, compliant and optimized for manufacturing process performance. There will also be an opportunity for some Design Assurance engineering support for products in development by driving and executing risk management and design control activities. This

Our mid sized medical device client is adding a Manager Regulatory Affairs to the team. The Manager ensures compliance with applicable laws and regulations in the development, manufacturing, and marketing of products and its subsidiaries’ products, and uses this knowledge to support pre-market and post-market activities and will work closely with Quality Assurance, Clinical Affairs, Sales and Marketing, Engineering, and Manufacturing for compliance to regulations. Your role with the company: Manage the daily operations of the Regulatory Affairs

Our clinical stage medical device client is adding a Principal Mechanical Engineer to the team. The Principal Mechanical Engineer will lead the design and development of new medical devices and the continuation engineering of existing medical devices. Compiles and analyzes operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials. Uses data to drive decision making and when data is not available designs experiments, creates prototypes, or completes calculations to support decision making

We have been retained by our cutting edge medical device design firm who is seeking to hire a Program Manager. The Program Manager will be part of every phase of the product life-cycle, from proposal to project kick-off, collaboration with engineers during design phase, and ultimately the timely completion and successful commercialization of our electromechanical medical devices. The Program Manager is expected to be a hands-on leader of project teams. They pair the Program Managers with experienced