Quality Validation Engineer II

Integer Holdings Corporation; Chaska (MN); On-site; USD 79,000 - 116,000; Full time

Benefits offered by this job

Medical insurance

401(k) with company match

Paid time off

Job summary

Integer Holdings Corporation is seeking a quality-focused engineer to join our team in Minnesota. You will participate in development projects, execute validation and test methods, and collaborate across DA, R&D, and NPI teams to ensure robust design verification and validation processes.

The role requires a bachelor’s degree in engineering with several years of related experience, strong problem-solving skills, and familiarity with QMS and regulatory standards.

Qualifications

• Bachelor's degree in engineering or related field and 3+ years of relevant experience; 7+ years may substitute education.
• Experience with quality systems and design controls.
• Ability to interpret design schematics and drawings.
• Strong written and oral communication, technical writing.

Responsibilities

• Adhere to ISO/FDA quality and safety requirements and company procedures.
• Participate in development project teams; perform quality/reliability activities.
• Generate and execute validation protocols and reports (IEQ, PQ, TMV, SWIQ).
• Support test protocols execution and DA lab activities.
• Collaborate with R&D and NPI teams to develop test methods and documentation.
• Lead improvements for legacy test methods.
• Assist with CAPA and risk assessment; update SOPs as needed.
• Review and approve engineering change requests.

Skills

Minitab

Problem solving

FDA/ISO knowledge

Schematics interpretation

ANOVA/DOE/SPC

Lean sigma tools

Lab equipment

Mechanical testing

Education

Bachelor's degree in engineering

Tools

SolidWorks

Job description

Integer Holdings Corporation is seeking a quality-focused engineer to join our team in Minnesota. You will participate in development projects, execute validation and test methods, and collaborate across DA, R&D, and NPI teams to ensure robust design verification and validation processes.

The role requires a bachelor’s degree in engineering with several years of related experience, strong problem-solving skills, and familiarity with QMS and regulatory standards.