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 hiring a Sr. Production Manager for the team. The Sr. Production Manager will oversee all daily operations of 2 sites from assembly and fabrication to ensuring policies and procedures are followed. This role is responsible for developing people and processes that will maximize safety, quality, productivity, and on-time delivery. This role requires strategic thinking, leadership, and hands-on management to drive excellence throughout operations. Reports to Director of Operations. Your role with

Our mid-sized medical device client is adding a Clinical Study Manager to the team! The Clinical Study Manager will report to the Director of Clinical and 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 ongoing study. The new study will

 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-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 mid-sized contract manufacturing client is adding a Design Engineer to plan and develop robust designs per customer specifications. They work with some of the largest medical device manufacturers, defense contractors, and other large growing industrial companies. Their high-tech equipment is the backbone of precision manufacturing. CNC machining stations with 3-axis, 4-axis, and 5-axis capabilities enable them to perform multi-dimensional machining with unparalleled accuracy and efficiency.   Your role with the company: Work with customers

Our mid-sized contract manufacturing client seeks a Mold Build Manager for the first shift to support their manufacturing facility. The Mold Build Manager will have 15 direct reports, including Lead Tool Maker, Tool Makers, Apprentice Tool Makers, and Drivers in a manufacturing and assembly environment. This role involves planning and assigning work, implementing policies and procedures, and recommending improvements in production methods, equipment, operating procedures, and working conditions. Additionally, the manager will be responsible for purchasing materials and scheduling

Our small start-up client is adding a Regulatory Assurance Manager to the team. The RA Manager will work cross-functionally and be responsible for providing regulatory assurance representation on engineering, operations, and clinical teams. The manager will also provide input for process/product improvements. Your role with the company: ·        This position takes ownership of the Quality Management System (QMS) and is responsible for QMS process development and execution. ·        This position has shared responsibility for product safety and quality in all

Our smaller medical device client is adding a Quality and Regulatory Manager to the team. The hands-on Manager will lead quality and regulatory as well as manage day-to-day operations of the QMS and in-house regulatory expert for US, EU, and global compliance. This position is responsible for implementation and maintenance of Quality System procedures related to operations, document and record control, customer feedback/complaint handling, and internal and external audits to assure compliance to Quality System Regulations

Our mid-sized medical device client is adding a Production Supervisor II to the team. The Production Supervisor will be a key leader in driving operational success, overseeing all aspects of daily operations, from assembly to fabrication, while ensuring strict adherence to policies and procedures. In this role, you will be responsible for developing and empowering both people and processes, with a focus on enhancing safety, quality, productivity, and on-time delivery. This position requires a strategic mindset combined with

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 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 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

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. This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed.  The Sr. Regulatory Affairs Specialist will perform regulatory submission/approval activities for all products and ensures compliance with required regulations and established corporate standards. Your role with the company: Preparing documentation for international regulatory registrations Preparing technical documentation

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