Design Assurance Engineer II — Quality & Validation

Integer Holdings; Chaska (MN); On-site; USD 79,200 - 116,160; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Disability insurance

Life insurance

Adoption benefits

Parental leave

401(k) with company match

Paid holidays

Paid time off

Job summary

Integer Holdings in Minnesota seeks a quality engineer to join the core team, driving QA activities across design, validation, and production processes. You will develop and execute test methods, support lab execution, and lead continuous improvement for legacy tests.

You will collaborate with R&D, NPI, and DA teams to ensure conformance to QMS and FDA requirements, analyze data with Minitab, and manage changes and documentation with precision.

Qualifications

• Bachelor's degree in engineering or related field; 3+ years of relevant experience preferred.
• Strong written and oral communication skills; ability to work in a team.

Responsibilities

• Adhere to Integer's values and all safety, environmental, security and quality requirements (QMS, FDA, etc.).
• As a quality Core Team member, participate in development projects and perform quality/reliability activities.
• Generate and execute validation protocols and reports (IEQ, PQ, TMV, SWIQ).
• Support DA lab staff during test protocol execution.
• Collaborate with DA, R&D, and NPI teams to develop, validate, and implement test methods; lead fixture design and test method qualification.
• Drive and support continuous improvement for legacy test methods.
• Provide support for root cause analyses, CAPA and Distributed Product Risk Assessment; update SOPs as required.
• Initiate, review, and approve engineering change requests; maintain documentation.
• Performs other functions as required.

Skills

Minitab experience

Problem solving

Quality systems knowledge

Interpreting schematics/drawings

Statistical methods (ANOVA, SPC, DOE,G

Lean Six Sigma tools

Lab measurement equipment

Mechanical/electrical test methods

SolidWorks

Education

Bachelor's degree in engineering or related technical field

Job description

Integer Holdings in Minnesota seeks a quality engineer to join the core team, driving QA activities across design, validation, and production processes. You will develop and execute test methods, support lab execution, and lead continuous improvement for legacy tests.

You will collaborate with R&D, NPI, and DA teams to ensure conformance to QMS and FDA requirements, analyze data with Minitab, and manage changes and documentation with precision.