We now have an opening for a Manager, Device Development for Medical Device / Combination Products.
Specific responsibilities include:
Serve as core team leader in development projects, perform and coordinate design reviews, and work with Quality Engineering to build DHFs.
Plan, conduct, analyze and document human factors activities.
Generate and develop new drug delivery device concepts.
Oversee development of custom methods, equipment, and their qualification for testing components, delivery devices and systems.
Maintain a high state of awareness of the competitive landscape and state-of-the art in drug delivery and identification of trends in clinical practice and regulatory landscape, including Digital Health.
Organize and oversee technology assessments of drug delivery technologies.
Collaborate with other teams at functional, departmental and divisional level to develop and execute innovation strategy.
Ensure all development activities are executed according to cGMP, and in alignment with design controls (21 CFR 820).
Support and participate in risk analysis activities.
Contribute to the preparation of regulatory submissions (e.g. BLA, sBLA, NDA).
Liaison with the Intellectual Property department to ensure FTO clearance and intellectual property protection.
Identify, select and manage external resources for product design, development and testing.
Drive improvement of the company's product development infrastructure, tools and processes.
BS degree in Mechanical Engineering, Product Design, Industrial Design or relevant engineering discipline. Advanced degree a plus. Minimum of 10 years of product development experience with a strong track record of achievement. Direct experience with medical devices, combination products, and/or drug delivery technologies a plus. Experience designing and managing Human Factors studies. Experience leading technical teams. Experience managing external vendors for product design, development and testing. Strong technical skills and creative mindset. Mastery of the fundamentals of engineering, with a focus on mechanisms, materials, fluidics and physics. Knowledge of manufacturing processes such as machining, metal forming, injection molding and assembly operations. Knowledge of 3D CAD and rapid prototyping technologies. Ability and willingness to generate documentation (test protocols, completion reports, product/process specifications, invention disclosures, etc.). Experience with design control in a medical device FDA regulated design environment is preferred. Strong communication skills and ability to work in a collaborative team environment a must. Pro-active, self-motivated personality.
This position is located in New Brunswick, NJ and may require up to 10% travel.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability
Job Function: Pharma Dev/Process Dev
Primary Location: NA-US-NJ-New Brunswick
Organization: R&D - PD - Drug Product Science & Technology
Bristol Myers Squibb