Senior Medical Device Design Quality Engineer

Cardinal Health; Mansfield (MA); On-site; USD 68,500 - 97,800; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Short- and long-term disability coverage

Paid parental leave

Healthy lifestyle programs

Job summary

A leading healthcare firm is looking for a Design Quality Engineer to ensure quality excellence in the development life cycle of medical devices. This role involves collaborating with cross-functional teams for design control processes, managing risk documentation, and resolving quality issues. Candidates should have a Bachelor's degree in engineering, 2+ years of experience, and a good understanding of medical device standards and regulations. Competitive salary offered based on experience and location.

Qualifications

• 2+ years of experience preferred in quality engineering or related field.
• Knowledge of medical device design and development processes.
• Understanding of AAMI, ANSI standards, GMP, ISO standards.

Responsibilities

• Create and review medical device design and development files.
• Develop risk management files throughout product lifecycle.
• Identify and resolve design-related quality issues in collaboration with teams.
• Lead continuous improvement activities and projects.

Skills

Attention to detail

Organizational skills

Problem-solving skills

Technical writing

Confident communication

Collaboration skills

Education

Bachelor’s degree in engineering or related field

ASQ CQE Certification

Tools

Statistical analysis tools

Root cause analysis

Job description

A leading healthcare firm is looking for a Design Quality Engineer to ensure quality excellence in the development life cycle of medical devices. This role involves collaborating with cross-functional teams for design control processes, managing risk documentation, and resolving quality issues. Candidates should have a Bachelor's degree in engineering, 2+ years of experience, and a good understanding of medical device standards and regulations. Competitive salary offered based on experience and location.