Scientist/Sr. Scientist, Device Engineering- Drug Delivery Systems
Cambridge, MA
Technical Operations – Quality Control /
Full-Time /
Hybrid
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.
