Senior Design Assurance Engineer

4 days ago


Fridley, Minnesota, United States Moffat Workforce Full time
About the Role

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.
Requirements
  • 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.
What We Offer

Moffat Workforce offers a competitive salary range of $100K-$135K annually.



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