Scientist/Sr. Scientist, Device Engineering- Drug Delivery Systems

We are seeking a highly skilled and motivated Drug-Device Combination Product Scientist/Sr.

Scientist to join our dynamic growing team.

The successful candidate will play a key role in the development of innovative drug-device combination products, contributing to the advancement of our therapeutic solutions.

This position involves a blend of research, development, and testing to enhance product performance and reliability.

We seek a dynamic individual with a passion for pushing the boundaries of technology and enhance patient lives through innovative dosage and drug delivery systems.

Position Responsibilities:

Contribute to the design and development of drug-device combination products, ensuring compatibility and functionality between the drug and device components.

Conduct comprehensive research to understand the interplay between drug product and device components.

Develop and implement robust testing strategies to assess the performance, safety, and efficiency of combination products.

Ensure compliance with relevant regulatory guidelines and standards (e.g., FDA, EMA) throughout the product development lifecycle.

Provide technical expertise to evaluate suitable technologies by conducting exploratory research to gather user insights and design trends. Translate user needs into product and system level requirements and specifications.

Participate in the upkeep of a comprehensive Design History File (DHF). Understanding of Design Controls, Usability Engineering, and Risk Management is essential.

Provide scientific and technical expertise in preparing regulatory submissions and documentation.

Stay abreast of emerging trends, technologies, and regulatory changes in the drug-device combination product field.

Manage multiple projects simultaneously, ensuring timely delivery of milestones.

Candidate Requirements:

Advanced degree (PhD, MEng, MS) in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related technical discipline with 3+ years of industry experience in device integration and development, combination product development, or advanced drug product development.

In-depth knowledge of medical device engineering, drug delivery systems and pharmaceutical formulation.

Strong expertise in experimental design, statistical analysis, and data interpretation.

Familiarity with the following standards: Design Controls (21CFR 820.30), Risk Management (ISO 14971); Quality Management (ISO 13485); Needle-based injection systems (ISO 11608-1); Good Manufacturing Practices (21 CFR Part 4, 21 CFR 210/211, 21 CFR 820); EU Medical Device Requirements (EU MDR 2021); Medical Electrical Equipment (EN 60601) and related requirements ISO 11040, ISO 3951 and ISO 2859.

Demonstrated strength in controlled development of user needs, market and system requirements, system and process verification and validation strategies, DOE/SPC/Risk Management Methods.

Proven experience in the development of drug-device combination products, with a strong track record of successful project completion.

Familiarity with regulatory requirements and guidelines for combination products.

Strong analytical and problem-solving skills, with the ability to think creatively and innovatively.

Excellent communication and interpersonal skills, with the ability to work effectively in a multidisciplinary team environment.

Full-Time