Senior Design Assurance Engineer
4 days ago
Moffat Workforce is seeking a highly skilled Senior Design Assurance Engineer to join our team. As a key member of our product development team, you will be responsible for ensuring the highest quality products are delivered to our customers.
Key Responsibilities- Quality Planning: Develop and execute quality plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects.
- Design Verification and Validation: Plan and execute design verification and validation activities, including root-cause analysis and resolution.
- Risk Management: Lead risk management activities from product concept through commercialization.
- Design Test and Inspection: Support design test and inspection method development and lead method validation activities.
- Design History File (DHF) Management: Ensure DHF content integrity, completeness, and regulatory compliance.
- Audit and Certification: Support internal and external audit responses and on-time product re-certifications.
- Customer and Product Requirements: Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements.
- Component Specification and Vendor Qualification: Support the development of objective component specification definitions and supplied component sampling plans.
- Biocompatibility and Sterilization: Provide support for biocompatibility and sterilization qualifications.
- Team Leadership: Develop and lead other team members and provide work direction as required.
- Education: Bachelor's degree in Industrial Engineering, Engineering, or Business.
- Experience: 8-15 years of medical device experience in Quality Operations or equivalent experience.
- Supervisory Experience: 1-3 years of supervisory experience preferred.
- Regulatory Knowledge: FDA regulations, ISO 13485, ISO 14971.
- Statistical and Data Analysis: Strong statistical and data analysis skills.
- Leadership and Management: Proven leadership and management skills.
Moffat Workforce offers a competitive salary range of $100K-$135K annually.
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Senior Design Assurance Engineer
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