Product Development Engineer

Company : Katalyst HealthCares & Life Sciences

Location : Southington, CT, 06489

Posted Date : 1 October 2025

Job Details

Job Description:
Our client, a leading medical device manufacturer, is seeking a Product Development Engineer to join their dynamic R&D team. This individual will play a critical role in the design, development, and validation of innovative medical devices that improve patient outcomes. The engineer will collaborate cross-functionally to translate user needs into design requirements, support prototype development, and ensure products meet all regulatory and quality standards.
Responsibilities:

Participate in the design and development of new medical devices, components, and systems from concept through commercialization.
Translate user needs and clinical requirements into robust engineering specifications and product designs.
Develop, evaluate, and refine design concepts, CAD models, and technical drawings using tools such as Creo, SolidWorks, or equivalent.
Collaborate with cross-functional teams including R&D, Quality, Regulatory, Manufacturing, and Clinical Affairs.
Conduct design verification and validation testing, ensuring compliance with FDA, ISO 13485, and other applicable regulations.
Support risk management activities including FMEA, hazard analysis, and mitigation strategies.
Document all design and development activities per Design Control requirements (21 CFR Part 820).
Provide technical input for design reviews, product specifications, and project plans.
Partner with suppliers and manufacturing teams to ensure design for manufacturability and scalability.
Investigate and resolve technical issues during prototype and production phases.

Requirements:

Bachelor's degree in mechanical engineering, Biomedical Engineering, Product Development Engineering, or related field.
3-7 years of experience in product development within the medical device industry.
Strong knowledge of medical device design controls, risk management, and regulatory requirements (FDA, ISO 13485, ISO 14971).
Proficiency in CAD tools (Creo, SolidWorks, or similar).
Experience with prototype development, design verification, and validation testing.
Hands-on experience with materials selection, tolerance analysis, and root cause problem solving.
Strong communication skills and ability to collaborate in cross-functional, regulated environments.
Preferred: Experience in Class II/III medical devices, disposable devices, or electromechanical systems.