Design Quality Engineer

Katalyst CRO; Marlborough (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company in the medical device industry is seeking a qualified candidate for a role focusing on design verification and validation. The ideal candidate will ensure compliance with FDA and ISO standards while managing design risk and collaborating with R&D and Regulatory teams. A technical background and experience in regulated industries are essential.

Qualifications

• 2-5 years experience in medical devices or regulated industry.
• Strong knowledge of regulatory requirements (FDA, ISO 13485, ISO 14971).
• Experience with verification & validation and root cause failure analysis.

Responsibilities

• Ensure design verification and validation activities meet regulatory requirements.
• Support new product development and ensure compliance with regulatory standards.
• Lead Health Risk Assessments for market products.

Skills

Design control

Risk management

Regulatory requirements

Statistical methods

Cross-functional collaboration

Education

Bachelor's degree in a technical field

Job description

Responsibilities

• Ensure design verification and validation activities meet regulatory requirements.
• Support new product development and sustaining engineering projects, ensuring compliance with FDA QSR, ISO 13485, and ISO 14971.
• Collaborate with R&D, Regulatory, and Quality teams to manage design risk and test method validation.
• Lead Health Risk Assessments for market products and evaluate design change impacts.
• Assess and document design inputs, usability, reliability, and biocompatibility standards.
  
  

Requirements:

• Bachelor's degree in a technical field.
• 2-5 years experience in medical devices or regulated industry.
• Strong knowledge of design control, risk management, and regulatory requirements (FDA, ISO 13485, ISO 14971).
• Experience with verification & validation, root cause failure analysis, and statistical methods.
• Ability to work cross-functionally and manage compliance documentation.
• Experience with test method validation, DOE, and failure analysis.
• Familiarity with sterilization, packaging, and software validation.