Product Development Engineer

Katalyst CRO; Boston (MA); Vor Ort; USD 120.000 - 170.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Drug delivery

Combination products

Design controls

DHF & lifecycle mgmt

ISO 14971 risk

Technical writing

Ausbildung

Bachelor's or Master's in engineering

Tools

JAMA

Windchill

Jobbeschreibung

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.

• 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.
• 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.

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 include 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