Principal Engineer, Device Development

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Title: Principal Engineer, Device Development Location: New Brunswick, NJ The Device, Delivery and Product Strategy team within the Global Product Development and Supply organization supports the BMS pipeline to create patient centric products. We now have a vacancy for a Principal Engineer to join our team and contribute to our success in meeting the needs of our business and our patients. The Principal Engineer is an important role in advancing cross-functional projects from ideation to commercialization directly influencing the success of our drug delivery devices. This role will involve leading cross-functional device development projects, evaluation and selection of robust device designs applying first engineering principles and multi-physics interactions, ensuring design for moldability / manufacturing, vendor selection and management, and developing fixtures and test methods using CAD design, prototyping and testing skills. The selected candidate will work in a fast-paced multidisciplinary environment as the competitive landscape keeps changing rapidly. Key Responsibilities: Lead cross-functional device development projects from concept through commercialization. Responsibilities include the selection, development, commercialization support, and lifecycle management support of drug delivery devices for various drugs within BMS pipeline. Project leadership activities include driving the establishment and validation of user requirements, translation into product/engineering specifications, design verification and validation activities, design reviews, design transfer and process validation activities, risk assessments, as well as post-market assessment activities leading to identification and implementation of potential product design improvements. Ensure that aspects of material selection and manufacturing processes are considered resulting in a robust design selection. Ensure design for moldability for internal designs as well as with external partners. Troubleshoot issues with molding as appropriate for product development and sustaining engineering activities. Identify new technologies for drug delivery and leverage understanding of first engineering principles, customer needs, and technical judgment to assess device platforms against internal and external needs, with emphasis on safety, efficacy, user convenience, design robustness, manufacturability, and other BMS business objectives. Develop intellectual property leading to differentiated drug delivery platforms. Vendor selection and management - Identify best-in-class industry partners to establish business relationships and leverage existing technologies to develop innovative and differentiated delivery device platforms, balancing internal versus external investment and development activities. Collaborate with Global Procurement and Legal to ensure robust and favorable contract terms for partnership activities. Maintain an overview of state-of-the art technology development within drug delivery by identifying trends in clinical practice and regulatory landscape, evaluating and benchmarking competitive products, processes or new trends which may impact BMS business. Develop and maintain a network of professionals/experts to advance BMS goals and be at the forefront of technology development and innovation. Use advanced engineering skills to design experiments and analyze the test results using statistical tools. Lead efforts in creating and developing methods and test stations for characterization, experimenting and testing components, delivery devices and systems. Ensure all development activities are executed in alignment with design controls, with the proper documentation for traceability. Support Regulatory filing activities. Responsibilities also include mentoring and developing other members of the Device Development team. Qualifications & Experience: Master's degree in mechanical engineering or other relevant engineering discipline. PhD is a plus. Minimum of 5 years (PhD) or 8 years (Masters) of relevant experience in the Biotech or related industry. Deep understanding of molding including interactions with product design, mold design and selection and molding process development. Understanding of multi-physics interactions, design for manufacturing and assembly. Design for environment would be a plus. Proficiency of software such as SolidWorks or ProE, Abaqus, HEEDS, MoldFlow is preferred. Broad and deep understanding of disciplined product development process, including design thinking , design controls, and regulatory submission process. Strong cross-functional perspective, leadership and influencing capabilities within a matrix organization. Strong written and verbal communication skills, with special emphasis on technical writing for regulatory filings. Strong technical skills and familiarity with competitive landscape, industry trends, and regulatory environment for combination products. #LI-Hybrid #GPSProdDev VETERAN If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Company: Bristol-Myers Squibb Req Number: R1588061 Updated: 2024-12-12 03:42:05.541 UTC Location: New Brunswick-NJ Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.