Sr Engineer, Device & Packaging Development - New Brunswick NJ

VetJobs; New Brunswick (NJ); On-site; USD 109,570 - 132,767; Full time

Job summary

VetJobs is seeking a Senior Engineer for Device and Packaging Development in New Brunswick, NJ. The role focuses on design controls, V&V, and risk management for drug-device combination products such as autoinjectors and wearable injectors.

The candidate will lead cross-functional efforts, develop DHFs and verifications, and ensure compliance with FDA and ISO standards while traveling up to 15% to collaborate with suppliers and manufacturing sites.

Qualifications

• Minimum 4 years of relevant experience in pharma/medical device industry.
• Master's degree required; PhD preferred.
• Experience with design controls, V&V, and FMEA.
• Knowledge of FDA 21 CFR Parts 4 & 820; ISO 13485, 14971, 11608.
• Experience with device and packaging materials and systems.
• Willingness to travel up to 15%.

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 across cross-functional teams to meet safety, efficacy, and usability requirements.
• Develop and maintain DHFs, design inputs/outputs, V&V documentation, and risk management records.
• Evaluate and develop novel device and packaging solutions focusing on sterile and oral dosage forms based on patient, user, and technical requirements.
• Manage device and packaging development activities from concept through launch within scope, timeline, and cost constraints.
• Provide technical expertise on device and primary packaging specifications and support manufacturing in problem resolution.
• Facilitate continuous improvement to increase productivity and establish group synergies with stakeholders.
• Maintain familiarity with evolving regulatory and compendia changes and translate trends into opportunities.
• Assist in sterile packaging and device constituent parts for regulatory filings.

Skills

Design controls

V&V

FMEA

Regulatory standards

Education

Master's in Mechanical/Biomedical/Industrial Engineering

PhD preferred

Job description

Senior Engineer, Device and Packaging Development

Job Type: Full-Time

Location: New Brunswick, NJ

Drug Product Development (DPD)

Our Drug Product Development team is committed to CMC design, development, and commercialization of innovative drug products to improve patient lives. We leverage the best people, collaboration, and cutting‑edge innovation to achieve this commitment. BMS’s internal engine of innovation includes unrivaled industry leading expertise in CMC development of small molecules, protein biotherapeutics, protein degraders, and other therapeutic modalities. We collaborate closely with our colleagues in R&D and Commercial to design our drug products. Here, you’ll get the chance to grow and thrive through opportunities that are uncommon in scale and scope.

Position Summary

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. The right candidate will bring the necessary skills, expertise, leadership, and passion for continuous improvement to an already dynamic team. Delivering on time, driving innovation, and fostering collaboration with stakeholders are key to this role.

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.
• Ability to travel domestically and internationally, up to 15%.
• Ability 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.

Compensation Overview

New Brunswick - NJ - US: $109,570 - $132,767

Salary Range >$100,000

City: New Brunswick

State: New Jersey