Senior Design Quality Engineer
Karwell TechnologiesRaynham, MA
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Overview
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On-site
Job Description
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.
- 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.
- 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.
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FAQs About Senior Design Quality Engineer Jobs at Karwell Technologies
What is the work location for this position at Karwell Technologies?
This job at Karwell Technologies is located in Raynham, MA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Karwell Technologies?
Employer has not shared pay details for this role.
What employment applies to this position at Karwell Technologies?
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