Design Assurance Engineer III

Integer Holdings Corporation • Plymouth, MN

1d

About The Position

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do. Customer We focus on our customers’ success Innovation We create better solutions Collaboration We create success together Inclusion We always interact with others respectfully Candor We are open and honest with one another Integrity We do the right things and do things right Lake Region Medical, Inc. dba Integer Holdings Corporation seeks Design Assurance Engineer III in Plymouth, MN. Duties: Adheres to Integer values and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), 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. Builds consensus where appropriate. Leads Risk Management (ISO 14971) activities. May lead cross functional teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Maintains risk management file for the life of the device. Generates and/or reviews related project deliverables such as: design verification and design validation protocols and reports as well as process validation protocols and reports. Coordinates with R&D in the review of technical documentation. Works with Product Development Manufacturing Engineering in the development of test fixtures, develop production acceptance criteria and test methodology. Coordinates sourced item qualification activities and supports supplier risk management initiatives. Conducts Independent review of DHF and Technical files, provides technical standards interpretation, and determines appropriate statistical methods, including sample size determination. Provides support in conducting root cause analyses, preparation of CAPA and Distributed Product Risk Assessment. Draft and update SOPs as required.

Requirements

• Requires a Master’s degree in Mechanical Engineering or related field required plus 5 years of experience.
• Requires 5 years of experience in the following: Quality Assurance: Use of Quality lean sigma tools (e.g. Root Cause Analysis, QFD, Ishikawa, Kepner-Tregoe).
• Requires 3 years of experience in the following: Creating risk management files per ISO 14971 for Class 2 or 3 devices per EU Medical Device Regulation (EU MDR 2017) or 510K FDA submission
• Performing Design Verification (creating protocols, executing testing and creating reports) for Class 2 or 3 devices for EU Medical Device Regulation (EU MDR 2017) or 510K FDA submission
• Performing Gage Repeatability and Reliability studies and Attribute Agreement Analysis for test method validation
• Performing Sourced Item Qualification (sourced component and supplier qualification)
• Investigating Non-Conforming Material, review and dispositions including review of schematics, drawings and design specifications.

Responsibilities

• Adheres to Integer values and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), 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.
• Builds consensus where appropriate.
• Leads Risk Management (ISO 14971) activities.
• May lead cross functional teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations.
• Maintains risk management file for the life of the device.
• Generates and/or reviews related project deliverables such as: design verification and design validation protocols and reports as well as process validation protocols and reports.
• Coordinates with R&D in the review of technical documentation.
• Works with Product Development Manufacturing Engineering in the development of test fixtures, develop production acceptance criteria and test methodology.
• Coordinates sourced item qualification activities and supports supplier risk management initiatives.
• Conducts Independent review of DHF and Technical files, provides technical standards interpretation, and determines appropriate statistical methods, including sample size determination.
• Provides support in conducting root cause analyses, preparation of CAPA and Distributed Product Risk Assessment.
• Draft and update SOPs as required.

Benefits

• Benefits discussed at interview.
• Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success.
• Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy.
• We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.
• Parental leave is 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.
• We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level