Senior Design Quality Engineer

Katalyst CRO; Raynham (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO in Raynham, MA is seeking a Senior Design Quality Engineer to lead quality engineering for medical device design and process changes, risk management, verification and validation activities, and compliance with medical device regulations.

The role requires close collaboration with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, Marketing, and Operations to support product development and sustaining engineering initiatives.

Qualifications

• Bachelor's degree in Engineering, Science, or related technical discipline.
• 5+ years in the Medical Device industry.
• Experience performing Process Verification and Validation activities.
• Experience conducting Design FMEA and/or Process FMEA.
• Strong knowledge of Design Controls and Quality Systems.
• Excellent problem-solving, analytical, and decision-making skills.
• Strong communication and cross-functional collaboration skills.
• Ability to manage multiple priorities and lead technical projects.
• Advanced degree (MS or higher) preferred.
• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related discipline preferred.
• Experience in New Product Development (NPD).
• Strong understanding of blueprint reading, inspection methods, and GD&T.
• Experience with Design Excellence, Lean Manufacturing, and Six Sigma methodologies.
• Medical device lifecycle management experience.
• Knowledge of FDA, ISO 13485, and risk management standards.

Responsibilities

• Support product lifecycle management with design and process changes.
• Lead and execute Design Verification and Validation (V&V) activities.
• Conduct Design FMEA and Process FMEA to identify and mitigate product and process risks.
• Ensure compliance with Design Controls and applicable medical device regulations.
• Collaborate with R&D, Manufacturing, Regulatory Affairs, and Marketing teams to support product development and sustaining engineering initiatives.
• Drive risk management activities and support change control processes.
• Participate in corrective and preventive action (CAPA) investigations and implementation.
• Support nonconforming material investigations and quality system improvements.
• Review and approve engineering documentation, protocols, reports, and design history files.
• Provide technical leadership for quality engineering projects and continuous improvement initiatives.
• Ensure compliance with applicable quality standards and regulatory requirements.

Skills

Cross-functional collaboration

Problem-solving

Analytical thinking

Project leadership

Communication skills

Education

Bachelor's degree in Engineering/Science

Advanced degree (MS or higher) preferred

Mechanical or Biomedical Engineering degree preferred

Job description

• The Senior Design Quality Engineer will support product lifecycle management activities for medical devices by providing quality engineering leadership for design and process changes, risk management, verification and validation activities, and compliance with medical device regulations.
• The role requires close collaboration with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, Marketing, and Operations.
• Support design changes and process improvements throughout the product lifecycle.
• Lead and execute Design Verification & Validation (V&V) activities.
• Conduct Design FMEA and Process FMEA to identify and mitigate product and process risks.
• Ensure compliance with Design Controls and applicable medical device regulations.
• Collaborate with R&D, Manufacturing, Regulatory Affairs, and Marketing teams to support product development and sustaining engineering initiatives.
• Drive risk management activities and support change control processes.
• Participate in corrective and preventive action (CAPA) investigations and implementation.
• Support nonconforming material investigations and quality system improvements.
• Review and approve engineering documentation, protocols, reports, and design history files.
• Provide technical leadership for quality engineering projects and continuous improvement initiatives.
• Ensure compliance with applicable quality standards and regulatory requirements.

Job Summary

• The Senior Design Quality Engineer will support product lifecycle management activities for medical devices by providing quality engineering leadership for design and process changes, risk management, verification and validation activities, and compliance with medical device regulations.
• The role requires close collaboration with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, Marketing, and Operations.

Roles & Responsibilities:

• Support design changes and process improvements throughout the product lifecycle.
• Lead and execute Design Verification & Validation (V&V) activities.
• Conduct Design FMEA and Process FMEA to identify and mitigate product and process risks.
• Ensure compliance with Design Controls and applicable medical device regulations.
• Collaborate with R&D, Manufacturing, Regulatory Affairs, and Marketing teams to support product development and sustaining engineering initiatives.
• Drive risk management activities and support change control processes.
• Participate in corrective and preventive action (CAPA) investigations and implementation.
• Support nonconforming material investigations and quality system improvements.
• Review and approve engineering documentation, protocols, reports, and design history files.
• Provide technical leadership for quality engineering projects and continuous improvement initiatives.
• Ensure compliance with applicable quality standards and regulatory requirements.

Education & Experience:

• Bachelor's Degree in Engineering, Science, or a related technical discipline.
• 5+ years of experience in the Medical Device industry.
• Experience performing Process Verification and Validation activities.
• Experience conducting Design FMEA and/or Process FMEA.
• Strong knowledge of Design Controls and Quality Systems.
• Excellent problem-solving, analytical, and decision-making skills.
• Strong communication and cross-functional collaboration skills.
• Ability to manage multiple priorities and lead technical projects.
• Advanced degree (MS or higher) preferred.
• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related discipline preferred.
• Experience in New Product Development (NPD).
• Strong understanding of blueprint reading, inspection methods, and GD&T.
• Experience with Design Excellence, Lean Manufacturing, and Six Sigma methodologies.
• Medical device lifecycle management experience.
• Knowledge of FDA, ISO 13485, and risk management standards.