Sr Engineer, Device & Packaging Development - New Brunswick NJ

About the role

The Sterile Product and Device Development team supports the BMS pipeline to create patient-centric products. This role is part of the Drug Product Development team and greater Product Development and Supply organization.

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.

Qualifications

• 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.
• 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.