NPI Quality Engineer - Medical Devices

KKR Consulting; New Hampshire; On-site; USD 85,000 - 110,000; Part time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A leading consulting firm is seeking a skilled NPI Quality Engineer to support medical device development. You will work with various teams to ensure compliance with industry standards such as ISO 13485 and FDA regulations. Ideal candidates will have a Bachelor's degree in Mechanical or Biomedical Engineering, along with 4–6 years of quality engineering experience in the medical device sector. The role offers a contract employment type with benefits including medical and vision insurance.

Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering or related field.
• 4–6+ years of experience in Quality Engineering within the medical device industry.
• Experienced with ISO 13485, FDA 21 CFR 820, and other relevant regulatory standards.

Responsibilities

• Participate in NPD and NPI projects ensuring quality and regulatory requirements.
• Lead quality deliverables including risk management and validation planning.
• Support design transfer to manufacturing ensuring compliance.

Skills

Mechanical Engineering

Biomedical Engineering

Quality Engineering

Root-cause analysis

Problem-solving tools

Cross-functional teamwork

Education

Bachelor's degree in relevant field

Tools

SolidWorks

Creo

NX

Job description

A leading consulting firm is seeking a skilled NPI Quality Engineer to support medical device development. You will work with various teams to ensure compliance with industry standards such as ISO 13485 and FDA regulations. Ideal candidates will have a Bachelor's degree in Mechanical or Biomedical Engineering, along with 4–6 years of quality engineering experience in the medical device sector. The role offers a contract employment type with benefits including medical and vision insurance.