Senior Quality Design Engineer

Insight Global; Maple Grove (MN); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A prominent staffing firm is looking for a Senior Quality Design Engineer in Maple Grove, MN. This role ensures product designs meet strict quality and safety standards while collaborating with cross-functional teams. Key qualifications include a Bachelor’s degree in Engineering and a minimum of 5 years' experience in design assurance within the medical device industry. Competitive salary range is offered, along with benefits including medical insurance and a 401(k).

Qualifications

• Minimum of 5 years of experience in design assurance within the medical device industry.
• Proficient with FDA, ISO, and IEC regulations and standards.
• In-depth understanding of design control and risk management principles.

Responsibilities

• Lead the design assurance activities and support product development.
• Develop and execute risk management and design control documents.
• Analyze testing data and prepare technical documentation.

Skills

Statistical analysis software

Design control principles

Cross-functional collaboration

Communication skills

Education

Bachelor’s Degree in Engineering

Master’s Degree in Engineering

Job description

Overview

Senior Quality Design Engineer role in Maple Grove, MN. This position focuses on ensuring that product designs meet quality and safety standards throughout the development process and collaborating with cross-functional teams to implement best practices in design assurance.

Compensation

Base pay range: $100,000.00/yr - $120,000.00/yr

Salary: Up to $120,000

Position details

• Title: Senior Quality Design Engineer
• Employment Type: Direct-Hire
• Location: Maple Grove, MN 55369

Qualifications

• Bachelor’s Degree in Engineering or a related field; Master’s preferred.
• Minimum of 5 years of experience in design assurance within the medical device industry.
• In-depth understanding of design control and risk management principles.
• Proficient with FDA, ISO, and IEC regulations and standards.
• Proficient in statistical analysis software and methodologies.
• Strong communication skills and ability to work collaboratively in cross-functional teams.
• Demonstrated problem-solving abilities and attention to detail.

Responsibilities

• Lead the design assurance activities and support product development through design verification and validation.
• Develop and execute risk management and design control documents, including DHF, DMR, and technical files.
• Drive the creation of test protocols and reports, ensuring compliance with regulatory and industry standards.
• Analyze testing data and prepare technical documentation for submissions to regulatory bodies.
• Oversee design reviews and provide constructive feedback to team members.
• Stay updated on industry trends and regulatory changes to continually enhance design assurance practices.

Benefits

• Medical insurance
• Vision insurance
• 401(k)