Junior Design Assurance Engineer - QA & Validation

Regulatory Jobs; Town of Clarence (NY); On-site; USD 59,000 - 86,000; Full time

Benefits offered by this job

Health, dental, vision insurance

Disability and life insurance

401(k) with company match

Parental leave

Job summary

Integer is seeking an entry-level Design Assurance Engineer to support design verification, validation, and risk management activities. You will work under mentors to learn test method development and regulatory compliance, including FDA requirements and QMS processes.

You’ll contribute to cross-functional projects, document procedures, and help ensure product quality from development through validation, while growing within a collaborative team.

Qualifications

• Bachelor’s degree in Quality, Engineering, or a related technical field and 0–3 years of experience.
• Ability to work independently as well as with cross-functional teams.
• Strong analytical and communication skills; proficient in statistics and Minitab.

Responsibilities

• Support design verification and validation activities per PDP requirements.
• Assist in risk management activities per ISO14971 and develop test methods.
• Review procedures and reports related to design assurance and product testing.
• Collaborate with cross-functional teams to ensure design outputs meet inputs and assist in root-cause analysis.

Skills

Statistics

Written and oral communication

Education

Bachelor's degree in Quality, Engineering, or a related technical field

Tools

Minitab

Job description

Integer is seeking an entry-level Design Assurance Engineer to support design verification, validation, and risk management activities. You will work under mentors to learn test method development and regulatory compliance, including FDA requirements and QMS processes.

You’ll contribute to cross-functional projects, document procedures, and help ensure product quality from development through validation, while growing within a collaborative team.