Senior Engineer, Device & Packaging Development - Sterile

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

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.