Katalyst CRO
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.
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. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Job function
Quality Assurance Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Quality Engineer jobs in
Marlborough, MA . Marlborough, MA $75,000 - $80,000 2 weeks ago Sterling, MA $75,504 - $101,553 2 weeks ago Chelmsford, MA $75,000 - $85,000 3 weeks ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
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. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Job function
Quality Assurance Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Quality Engineer jobs in
Marlborough, MA . Marlborough, MA $75,000 - $80,000 2 weeks ago Sterling, MA $75,504 - $101,553 2 weeks ago Chelmsford, MA $75,000 - $85,000 3 weeks ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr