Product Development Engineer

Intellectt Inc; Plymouth (MN); On-site; USD 80,000 - 110,000; Full time

Job summary

A medical equipment company in Plymouth, MN seeks a Product Development Engineer to improve legacy test methods in alignment with current standards. The role emphasizes collaboration with R&D, Quality, and Regulatory Affairs. Candidates should have a Bachelor's degree in Engineering, a minimum of 4 years in the medical device industry, and proficiency in SolidWorks.

Qualifications

• Minimum 4 years of experience in the medical device industry.
• Strong expertise in test method development, validation, and remediation.

Responsibilities

• Review and assess legacy test methods and identify gaps.
• Collaborate with R&D, Quality, and Regulatory Affairs.
• Prepare technical documentation for audits.

Skills

Test method development

Validation

Remediation

SolidWorks proficiency

Risk assessment tools (FMEA)

Education

Bachelor’s degree in Engineering or related discipline

Tools

SolidWorks

Job description

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.

Key Responsibilities

• 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 SolidWorks to support updated methods.
• Ensure compliance with applicable regulatory and industry standards.
• Prepare technical documentation and provide support during internal audits and reviews.

Qualifications & Skills

• 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 SolidWorks for fixture design and development.
• Familiarity with risk assessment tools (e.g., FMEA).

Details

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