Principal Engineer, Device Engineering (R1550585-en-us)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Position: Principal Engineer, Device Engineering
This position provides global technical leadership for the commercial product lifecycle management (LCM) of the device and combination products in the company. This position is also accountable for the technical interface with product development during the commercialization and technology transfer of new device and combination products such as prefilled syringe, autoinjector, and other combination products. This individual has technical ownership of LCM change controls, technical investigations, and global technology transfer to internal and external manufacturing sites.
MAJOR DUTIES AND RESPONSIBILITIES:
- Lead technical workstreams for lifecycle management of commercial device and combination products, including but not limited to: change controls, technical investigations, technology transfer, supplier management, risk analysis, component and process improvements.
- Collaborate with device development, marketing, supply chain, procurement, logistics, internal and external manufacturing sites, to successfully develop, tech transfer and launch device and combination products.
- Support sites globally to resolve significant quality events and manage complex change controls. Evaluate changes (component, product, process) post design transfer to assess risk/impact on manufacturing process, documentation and design control elements.
- Work with cross-functional teams to assist in the development of engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans. Ensures measurement systems analysis (MSA’s) for all finished product performance test methods as needed in tech transfer or lifecycle.
- Participate in design reviews and provide technical input. Review supporting documentation, approving documents as part of tech transfer, and ensure those documents are suitable to minimize risk to commercial manufacturing, supply, and patients.
- Employs project management practices for developing project timelines, resources, monitoring progress and project status communication.
- Support site investigations, lead center led investigations, and product complaint trends related to device components. This includes forensic analysis of complaints, understanding useage, conducting Design of Experiments, and application of other engineering tools to determine root cause and ensure components and materials meet BMS performance and quality standards
- Support device and combination products related regulatory filings pre and post approval
- Support Manufacturing sites, Procurement, Global Quality and Compliance in supplier, customer, internal, and/or regulatory agency audits and provide technical leadership of supplier robustness, which includes assessments of component manufacturers’ supply capability.
- Responsibilities also include mentoring and developing other members of the Global Packaging Technology in device and packaging as well as cross training to expand knowledge in other disciplines within the organization.
KNOWLEDGE / SKILL:
- BS degree in Mechanical Engineering, Biomedical Engineering, Material Engineering, or relevant engineering discipline. Advanced degree a plus.
Experience / Knowledge Desired:
- Minimum 8 years work experience with Bachelor’s degree, 6 years with advanced degree in the Medical Device, Pharmaceutical or Biotechnology industry
- Expert in drug-delivery medical device and combination products design and/or manufacture. Prior experience with prefilled syringe or autoinjector a plus.
- Thorough knowledge of design control and quality systems regulations (21 CFR 820 & 211, ISO 13485) related to medical device and combination products.
- Strong analytical, technical writing, interpersonal, and communication skills with ability to present internally/ externally to suppliers, sites, health authorities, and Sr. Management.
- Demonstrated ability to manage multiple programs and create a high performance work environment. Work in a matrix environment and effectively support internal & external manufacturers and suppliers
- Thorough understanding of statistical sampling plan.
- Packaging development experience a plus
- Manufacturing experience a plus
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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