Onsite Senior Drug-Device Product Development Engineer

Katalyst CRO; Boston (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Katalyst CRO in the Boston area seeks a Senior Product Development Engineer to support design and development of drug-device and biologic-device combination products in a regulated environment. This onsite role is based in the Boston, MA or Providence, RI area, focusing on drug delivery systems and end-to-end product lifecycle.

The role requires authoring DHF, ensuring compliance with FDA, EU MDR, ISO, and internal quality systems, and transferring technology from development to manufacturing.

Qualifications

• Bachelor's or Master's degree in engineering or related field.
• 510 years of experience in medical devices or combination products.
• Strong experience with drug delivery systems and combination products.
• Expertise in design controls, DHF, and product lifecycle management.
• Hands-on experience with risk management (ISO 14971).
• Knowledge of FDA regulations, EU MDR, ISO 13485, and 21 CFR Part 820.
• Experience with tools like JAMA and Windchill.
• Strong technical writing, communication, and organizational skills.
• Ability to work independently and manage multiple projects.

Responsibilities

• Author and maintain design control documentation, including Design History Files (DHF).
• Ensure compliance with FDA, EU MDR, ISO standards, and internal quality systems.
• Support product development and technology transfer from early development through commercial manufacturing.
• Translate user needs into functional requirements and design outputs.
• Support Human Factors Engineering (HFE) activities.
• Develop specifications, design outputs, packaging, and verification plans.
• Perform risk management activities include DFMEA, PFMEA, and UFMEA.
• Contribute to requirements management, quality systems, and risk processes.
• Work cross-functionally in a fast-paced development environment.

Skills

Drug delivery

Combination products

Design controls

DHF & lifecycle mgmt

ISO 14971 risk

Technical writing

Education

Bachelor's or Master's in engineering

Tools

JAMA

Windchill

Job description

Katalyst CRO in the Boston area seeks a Senior Product Development Engineer to support design and development of drug-device and biologic-device combination products in a regulated environment. This onsite role is based in the Boston, MA or Providence, RI area, focusing on drug delivery systems and end-to-end product lifecycle.

The role requires authoring DHF, ensuring compliance with FDA, EU MDR, ISO, and internal quality systems, and transferring technology from development to manufacturing.