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A BDN client is looking for an Automation Engineer to join their team. The cleaning cycles are already designed and run successfully at this time. Updates made to the cycle may need additional design modifications in addition to qualification work, including automation OQ and CIP OQ. Once the design modifications are identified and completed, the equipment will require an OQ, CIP OQ, and some SIP PQ along with a coinciding change control to release the equipment for GMP use. The consultant will work with the Senior Project Engineer on commissioning and validation of new cleaning cycles.

A BDN client is working through the last stages of a Phase III study and is looking for an experienced Medical Director to join their team. The trial is a Nephrology study, so this professional MUST have experience in Nephrology and extensive experience in Clinical Development. The client would like to make sure this Medical Director has reviewed/interrupted data and contributed to NDA activities/submissions. Lastly, there will be no training; they want this individual to be able to jump in and engage in the first couple of hours. They are NOT looking for Medical Monitors. An MD degree or Master's Degree/Ph.D. in Epidemiology is desired for this role.

A BDN client is looking for a Statistical Programing Lead to join their team. This consultant will be responsible for developing, revising, and maintaining Standard Operating Procedures and Work Instructions. Defining quality requirements and developing/implementing quality practices, including SAS program validation procedures and documentation, is needed. Developing and maintaining good communications and working relationships with internal/external functions is also essential. The client would like the consultant to communicate progress, milestones, and issues to function and department management.

A BDN client is looking for an RF Test & Debug Consultant to join their team. The consultant must have extensive experience in RF circuits up to 50 GHz, including solid-state switches, amplifiers, mixers, and synthesizers (VCOs and PLLs). He/she must also have experience using RF and microwave test equipment such as VNAs, PNAx, spectrum analyzer, power meter, and automated test equipment. Knowledge of the fabrication and testing of microwave components and modules, including wire and ribbon bonding, Printed Circuit Board fabrication, shielding, and isolation is desired. ·

A BDN client is in need of two Process Engineers to support an ongoing device development project for the next three months. The client is looking for consultants with 5-10 years of experience in the medical device and drug delivery industry. Experience with drug delivery devices that utilize tube sets (IV style tube sets), thermal bonding of plastics, as well as experience with adhesive bonding of plastics, especially light-curable epoxy is needed for this role. He/she will design, conduct, and document DOEs (Design of experiments) in this role. A Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, or similar fields is desired for this role.

A BDN client is looking for a Project Manager who will be the point of contact, SME, as the right hand to the CTO supporting Class II Devices from inception design through 510k clearance. This person will need to have lead product development as a Project Manager in the past. Prior experience with Software Medical Device would be a huge plus, but Medical Device experience is a must. This role will be to manage the teams cross-functionally, work with technical leads to define risk, how to increase efficiency, handle scheduling, and project planning to mitigate the bumps in the process from prior experiences.

A BDN client is starting the final phase of clinical trials and has both Pharmaceutical and Device elements to the product. This consultant needs to be a Subject Matter Expert with Quality Management Systems with a small start-up environment. They do not want large Pharmaceutical or Medical Quality Systems that can be too cumbersome to work within. They are hoping to have an expert work with there team to build the initial framework of the systems. They would like this person to assess the systems and put a framework system that allows them to build out to cover the full range of products. Also, they have implemented a new PLM system (Arena) that should be going live very soon.

A BDN client is looking for a Senior Medical Director who will lead the direction, planning, execution, and interpretation of clinical trial activities of novel compounds in various indications through early development to global regulatory submissions. The consultant will lead and demonstrate ownership of the design and implementation of a clinical development program or programs in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, markets, business operations, and emerging issues. They will also oversee project-related education of investigators, study site personnel, and study staff.

A BDN client is looking for a talented individual to join their software development team in the design and implementation of application and system-level software on an embedded Windows platform. This individual is expected to work both independently and collaboratively as a member of their group during the development and implementation of new software features. A qualified candidate will be able to: understand software requirements, objectively analyze problems, efficiently design and implement solutions, and document their work. A Bachelor's Degree in Computer Science or related studies is desired. A Graduate Degree is preferred for this role.

A BDN client is looking for a Project Engineer resource to help to manage project activities and create solutions. The consultant will be creating solutions for processes related to projects, procedures, and operations. Helping to develop or close activities specific to the project is needed. He/she will be working with repackaging and labeling processes and procedures from the compliance perspective. Packaging will involve outer packaging; labeling will be more on the compliance side. Experience with labeling departments and quality representation to the labeling department is desired. The client is not looking for a Quality Engineer but working on systems that help create repackaging and labeling activities.