Product Development Engineer

Katalyst CRO; Boston (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a Senior Product Development Engineer in Boston, MA to support the design and development of drug-device and biologic-device combination products. The role involves authoring design control documentation, ensuring compliance with FDA and ISO standards, and supporting product development from early stages through manufacturing. Ideal candidates should have a degree in engineering and 5-10 years of relevant experience, including expertise in drug delivery systems and design controls. Strong technical writing and communication skills are essential.

Qualifications

• 5-10 years of experience in medical devices or 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.

Responsibilities

• Author and maintain design control documentation.
• Ensure compliance with FDA, EU MDR, and ISO standards.
• Support product development and technology transfer.
• Translate user needs into functional requirements.
• Support Human Factors Engineering (HFE) activities.

Skills

Medical devices experience

Drug delivery systems

Risk management

Design controls

Technical writing

Communication skills

Organizational skills

Education

Bachelor's or master's degree in engineering or related field

Tools

JAMA

Windchill

Job description

Job Summary

Senior Product Development Engineer to support the design and development of drug-device and biologic-device combination products for a fast-growing biotechnology company. The role focuses on drug delivery systems, design controls, and end-to-end product lifecycle support in a regulated environment. This is an onsite role based in the Boston, MA or Providence, RI area.

Roles & 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 including DFMEA, PFMEA, and UFMEA.
• Contribute to requirements management, quality systems, and risk processes.
• Work cross-functionally in a fast-paced development environment.

Education & Experience

• 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