Our smaller bioelectronic medical device client is adding a Senior or Principal Product Development Engineer to the team. The Engineer will be responsible for technical leadership and timely development of new technologies and devices to support the needs of the customer. This requires representation for the department in inter-company relations and providing technical expertise to internal clients and the customer. Responsible for creating and sending design files to PCB fab houses for quotes and working through EQs with the

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

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

Our small medical device client is adding a Clinical Study Project Manager to the team! The position will report to the Sr. Director of Clinical and will serve a key role in the Clinical Operations department and the company.  The primary responsibility of this position is to provide clinical research expertise to support both internal teams and external customers on the science. Candidates will have the opportunity to thrive in a dynamic, entrepreneurial, and highly collaborative environment contributing to all

Our mid-sized medical device client is adding a Quality Manager to the team! The Quality Manager will have the opportunity to be a key leader 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 medical devices

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 bioelectronic medical device client is adding a Product Development Engineer to the team. The Product Development Engineer will manage projects  (3-5 at a time) and create fixtures for assembly.  Will also be responsible for the development and implementation of new products, developed jointly with Manufacturing Engineering, into full production, as well as supporting of continuation engineering on existing product lines. Will be collaborating with 4 Engineers and a Technician. Your role with the company: Product Concept – Basic

Our smaller bioelectronic medical device client is adding a Sr. Product Development Engineer to the team. The Sr. Product Development Engineer will manage projects as well as be responsible for development and implementation of new products, developed jointly with Manufacturing Engineering, into full production, as well as supporting of continuation engineering on existing product lines. Your role with the company: Product Concept – Basic understanding of user and patient needs – Proposes concepts to address customer needs – Selects and documents concepts to

Our mid-sized medical device client is adding a Sr. Design Assurance Engineer to the team. This role is responsible for supporting design assurance throughout the product lifecycle. Design Assurance Engineers work with the development, manufacturing, and quality team to ensure devices are designed in accordance with product requirements, ISO 13485, and 21 CFR 820. They develop and maintain risk management plans, sterilization plans, audit against the requirements for the DHF, and provide feedback on product requirements, risk assessments, and

Our mid-sized client is adding a Sr. Supplier Quality Engineer to the team. The Senior Supplier Quality Engineer will lead the coordination of onboarding and sustaining relationships with suppliers.  This individual will evaluate and communicate quality issues to suppliers and apply sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. They will review and approve supplier corrective action plans and verification of effectiveness documentation. Through consistent communication they will maintain relationships with suppliers to ensure changes

Our small start-up client is adding a couple Field Clinical Specialists (FCS) to the team. The FCS will report to the VP CL/RA and is an externally facing position that interacts directly with clinical investigators and other study staff at a clinical research site to support proper subject enrollment and use of the device during a clinical study.  The CFS must show proficiency in the disease state under study as well as the device being utilized and will be

Our small start-up client is adding a Clinical Trial Manager (CTM) to the team! The CTM will report to the VP Clinical/Regulatory/Quality and will play a critical role for the successful conduct of a clinical study.  As an internal and externally facing position, this position interacts directly with the internal study team, regulatory affairs, legal, marketing and R&D along with clinical vendors, physician consultants, clinical Investigators and other study staff at a clinical research site.  The CTM

Our small start-up client recently received FDA approval to start an early feasibility trial and are adding a Field Clinical Manager or Director to the team. The FCS will report to the VP Clinical, Regulatory, and Operations. This will be the first FCS for their second generation product. This position will manage the clinical engineering team and all field activities related to the organization’s sponsored clinical research programs.  Primary responsibilities will include the recruitment, development and management of

Our mid-sized medical device client is adding a Sr. Director of Regulatory to the team. The Sr. Director, Regulatory Affairs will 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. There will be multi site responsibility along with U.S. FDA regulations and the European/International regulations.   Your role with the company: Manage the daily operations of the Regulatory Affairs department, including the management

Our mid-sized medical device manufacturing client is adding a Senior Design Assurance Engineer to the team! The Senior Design Assurance Engineer will utilize risk management and quality planning activities to provide quality engineering support of 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 teams to ensure compliance to CFR 820.30

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

We have been retained by our smaller medical device client as they are a adding a Vice President of R&D. Our client provides products and services to cardiac, vascular, and other speciality surgical applications.The VP R&D is a key member of the management team and has direct responsibility to oversee internal development projects and development of products for new and existing customers. This position will work closely with other functional departments on internally developed and customer

Our larger medical device client is adding a Director of Regulatory to their team! The Director Regulatory Affairs will provide regulatory guidance, leadership, and expertise to develop global strategies and execute regulatory submissions within the United States (US) and European Union (EU).  You will collaborate directly with R&D engineering, and other functional areas, to provide regulatory guidance and insight throughout the product development process (PDP) process. This is a people and project management role with responsibility to manage

Our growing, mid-sized medical device client is adding to their Medical Affairs team. The Sr. Medical Affairs Program Manager is responsible for driving and executing companies’ agenda in the clinical community with the objectives of driving understanding of and evidence for companies’ product. Ideal candidate will have a strong ability to interpret clinical and real-world evidence, business acumen and KOL influence skills as well as a broad range of evidence generation experiences from within the medical device industry

Our well funded smaller medical device client is adding a Sr. Clinical Research Associate to the team. The Sr. CRA will start a double blinded IDE trial from scratch and ensures the overall quality of clinical trials by monitoring study data and managing site adherence to the protocol, GCP, all applicable regulations and related study documents. The Sr. CRA is the primary contact with the study site and serves as the liaison between clinical investigators and the Sponsor. Your role