Product Development Engineer

Overview

Location:

Plymouth, MN

Long Term Contract

The Product Development Engineer will be responsible for evaluating and remediating legacy test methods to ensure alignment with current industry standards and regulatory requirements. This role focuses on identifying gaps and inconsistencies in existing methods, implementing improvements, and ensuring risk-based justification and traceability of all updates. The engineer will collaborate closely with cross-functional partners in R&D, Quality, and Regulatory Affairs while supporting compliance and audit readiness.

• Review and assess legacy test methods and identify gaps, inconsistencies, and improvement opportunities in current test methods.
• Remediate test methods to meet updated standards, best practices, and regulatory expectations.
• Perform risk assessments for changes and document justification with complete traceability.
• Collaborate with R&D, Quality, and Regulatory Affairs to drive method improvements.
• Design and refine test fixtures using Solid Works to support updated methods.
• Ensure compliance with applicable regulatory and industry standards.
• Prepare technical documentation and provide support during internal audits and reviews.

• Bachelor’s degree in Engineering or related discipline.
• Minimum 4 years of experience in the medical device industry.
• Strong expertise in test method development, validation, and remediation, and proficiency in Solid Works for fixture design and development.
• Familiarity with risk assessment tools (e.g., FMEA).

• Seniority level:
  Mid-Senior level
• Employment type:
  
  Contract
• Industries:
  Medical Equipment Manufacturing