Senior Engineer, Device and Packaging Development

About the role

The Sterile Product and Device Development team within the Drug Product Development team and greater Product Development and Supply organization supports the BMS pipeline to create patient centric products. We now have a vacancy for a Senior Engineer, Device and Packaging Development to join our team and contribute to our success in meeting the needs of our business and our patients.

Responsibilities

• Support design, development, evaluation and lifecycle management of drug-device combination products (e.g., autoinjectors, prefilled syringes, wearable injectors, nasal delivery devices).
• Lead and execute technical tasks and projects with limited supervision, contributing to cross-functional teams to ensure combination products meet safety, efficacy, and usability requirements across the development lifecycle.
• Develop and maintain design history files (DHFs), design inputs/outputs, verification & validation (V&V) documentation, and risk management records.
• Evaluate and develop novel device and packaging solutions, focused on sterile and oral dosage forms, based on patient, user, and technical requirements.
• Manage device and packaging development activities from concept through launch while maintaining project objectives, timelines, and costs.
• Provide technical expertise in the development of device and primary packaging component specifications, and support manufacturing teams assisting in resolving problems associated with device and packaging components.
• Facilitate continuous improvement initiatives to increase productivity of team and establish group synergies with stakeholder organizations.
• Maintain familiarity with evolving regulatory and compendia changes and translate device and packaging industry trends into business opportunities.
• Provide technical assistance on sterile packaging and device constituent parts for quality and regulatory activities, including preparation of technical documents for regulatory filings.
• Partner with key stakeholders to ensure system-level requirements for drug device combination products are developed, verified, and validated in accordance with design controls.

Requirements

• Minimum 4 years of relevant experience in the pharmaceutical, biotechnology, or medical device industry; experience in healthcare, food, or cosmetic industries is also relevant.
• Minimum of a Master’s degree in Mechanical, Biomedical, or Industrial Engineering, or a relevant science and engineering discipline; PhD preferred.
• Working knowledge of design controls, V&V execution and FMEA.
• Working knowledge of FDA 21 CFR Parts 4 & 820; ISO 13485, 14971, 11608 standards.
• Solid background in materials, such as glass, plastics used for containers, rubber closures, seals, syringes.
• Experience in writing, executing, reporting, and presenting device and packaging system evaluations.
• Strong understanding of global regulations regarding device and packaging.
• Able to manage multiple tasks with minimal supervision and independently prioritize activities based on timelines.
• Able to apply Lean and Six Sigma methodologies to process and product improvement is a plus.

Qualifications

• Demonstrated Ability To: Influence areas not under direct control to achieve objectives.
• Work in a matrix environment and effectively support internal & external manufacturers and suppliers.
• Apply design controls, V&V, and risk-management principles across the combination product lifecycle.
• Apply strong technical, analytical and problem-solving skills, as well as strong mechanical aptitude.
• Apply strong technical writing skills to draft protocols, reports, test methods, procedures, work instructions.
• Communicate effectively, including internal/external presentations to suppliers, sites, and Sr. Management.

Skills

• Strong understanding of global regulations regarding device and packaging.
• Strong technical, analytical and problem-solving skills, as well as strong mechanical aptitude.
• Strong technical writing skills to draft protocols, reports, test methods, procedures, work instructions.
• Influence areas not under direct control to achieve objectives.
• Effective communication, including internal/external presentations to suppliers, sites, and Sr. Management.

Benefits

Bristol Myers Squibb offers 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.