Design Assurance Engineer II- Chaska

Key Accountabilities and Responsibilities

• Adhere to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
• Actively participates in development project teams.
• Performs quality/reliability engineering activities to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled.
• Generates and executes validation protocols and reports (IEQ, PQ, TMV, SWIQ) for design verification test methods.
• Supports DA lab staff during design verification and design validation protocols execution (test).
• Collaborates with DA, R&D, and NPI teams to develop, validate, and implement test methods.
• Leads efforts in fixture design, test method qualification, and creation of clear, accurate work instructions.
• Drives and supports continuous improvement initiatives for legacy test methods.
• Provides support for root cause analyses, CAPA and Distributed Product Risk Assessment and updates SOPs as required.
• Initiates, reviews, and approves engineering change requests and documentation.
• Performs other functions as required.

Specialized Knowledge & Experience

• Experience with statistical software packages such as Minitab.
• Demonstrated problem solving skills.
• Knowledge of ISO and FDA quality, process validation and system requirements.
• Experience in interpreting design schematics and drawings.
• Skilled in statistical methods e.g. ANOVA, SPC, sample size determination, Gauge R&R and DOE.
• Knowledge of quality lean sigma tools (e.g. Root Cause Analysis, QFD, Ishikawa, Kepner-Tregoe).
• Experience with Lab Measurement equipment (Microscope, Caliper, Multimeter, Tensile tester, Vision Systems, etc).
• Knowledge of mechanical and electrical test methods (Tensile, 3-point bend, coating performance, torqueability, trackability, fatigue tip stiffness, leak test, continuity, resistance, particulate, etc).
• Solid Works experience.

Job Requirements

• Minimum Education: Bachelor’s degree in an engineering or related technical field; at least three years of relevant experience. Candidates without a degree may qualify with seven or more years of relevant experience.
• Ability to work independently as well as collaboratively with other associates and cross-functional teams.
• Strong written and oral communication skills, including technical writing.
• Demonstrated ability to work in a team environment.
• Functional understanding of the Integer Quality Management Systems and ability to complete required Quality System documentation tasks with little or no direction from others.
• Maintains a calm demeanor that transcends the high energy, constantly changing production environment.
• Possesses a positive, can-do attitude with an underlying belief that failure is not an option.

Salary Range

$79,200 - $116,160

Total Rewards

• Compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy.
• Comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.
• Parental leave available after one year.
• Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance.
• Employees are immediately eligible to participate in the 401(k) plan with company matching contributions.
• Eighty hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

EEO Statement

U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.