Collabera | Development Quality Engineer | saint paul, mn

1 week ago

saint paul, United States Collabera Full time

The Senior Development Quality Engineer will act as a technical expert providing design quality oversight and expertise to product development teams. This role ensures compliance with regulatory requirements and quality standards while maintaining strong collaborative partnerships across cross-functional teams to prioritize patient/user safety, customer satisfaction, and organizational goals.


Key Responsibilities:

  • Design Control: Lead and support the timely completion of Design Control deliverables throughout the product lifecycle.
  • Product Requirements: Support the definition of objective, measurable, and verifiable product requirements.
  • Verification & Validation (V&V):
  • Plan and execute Design Verification and Validation activities.
  • Investigate and resolve cross-functional V&V issues to ensure product quality.
  • Risk Management:
  • Lead Risk Management activities from product concept through commercialization.
  • Develop and maintain risk documents, including FMEAs and risk assessments.
  • Test Method Validation:
  • Support the development of test methods.
  • Lead validation activities for test methods to ensure reliable performance.
  • Manufacturing Process Development:
  • Collaborate on process development and qualification for new products and design changes.
  • Establish and define component specifications, sampling plans, and vendor qualifications.
  • Biocompatibility & Sterilization:
  • Support biocompatibility and sterilization qualification processes.
  • Audits & Compliance:
  • Participate in audits and contribute to quality system improvements to ensure compliance with applicable standards and regulations.
  • Adhere to Abbott, FDA, EU MDR, and other regulatory requirements.
  • Collaboration & Communication:
  • Maintain positive, cooperative communication and teamwork with employees, customers, contractors, and suppliers.
  • Contribute to the Quality Management System (QMS), Environmental Management Systems (EMS), and other organizational initiatives.


Basic Qualifications:

  • Bachelor’s degree in Engineering or a related technical field.
  • Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, or Quality, with at least 2 years supporting product development activities.
  • Experience with medical devices and knowledge of applicable regulations and standards.
  • Proficiency in test method development and validation.
  • Hands-on experience in preparing risk documents such as FMEAs and risk assessments.


Preferred Qualifications:

  • Advanced degree in Engineering or a technical field.
  • Experience working with active implantable medical devices.
  • Knowledge of requirements management tools (e.g., DOORS) and problem reporting systems (e.g., JIRA).
  • Proficiency in applying statistics to verification and validation activities.


Key Competencies:

  • Strong problem-solving and analytical skills.
  • Excellent communication and collaboration abilities.
  • Detailed understanding of design control processes and risk management principles.
  • Commitment to quality and compliance with regulatory standards.

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