Design Assurance Engineer III

Integer Holdings Corporation • Plymouth, MN

1d • Remote

About The Position

The primary purpose of this role is to execute and support the Design Assurance group in areas including Design verification, design Validation, statistics, risk management, test method development and standards, test method validation, sourced item qualification, design input requirements (spec generation), ensuring design outputs meets inputs, design transfer support, and process validation support for Integer owned products. The Design Assurance group also supports process development projects. The engineer will ensure that Integer’s internal and external customer expectations are met or exceeded with the direction, instruction and guidance from more experienced engineers and managers. This role involves learning the application of design assurance and product test development and testing concepts in the design & manufacture of Integer's product lines. The individual must 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.

Requirements

• Bachelor’s degree in an engineering or related field (or 10+ years of relevant experience if no bachelor's degree)
• 5+ years of progressive engineering and/or technically focused roles and experiences
• Strong technical and problem-solving foundation
• Awareness of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)
• Good knowledge in Microsoft Office
• Solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual.
• Competencies in both written and oral communications (for outside of US countries, written and oral English communications).
• Maintain a calm demeanor that transcends the high energy, constantly changing production environment.
• Possess a positive, can-do attitude with an underlying belief that failure is not an option.
• Strong working knowledge of Statistics and the use of Minitab
• Considered as an SME for statistics.

Nice To Haves

• Master’s degree
• Training and certifications, in a variety of problem-solving and project management methodologies such as 6-Sigma (green belt as a minimum, black belt preferred)

Responsibilities

• Develop new test methods and improve existing methods including design and manufacture of new tooling, fixtures, and templates.
• Carry out testing and validation of new test methods including gage R&R studies and statistical analysis of data through software packages such as Minitab.
• Update test method procedures and design assurance standard operating procedures as required.
• Provide technical input into root cause analysis.
• Generate investigation reports within KPI metrics and timelines and route for approval.
• Participate and provide technical input on cross functional reviews of open field and customer returns.
• Review procedures, protocols, reports, and other documents related to design assurance, test method development, product development and product testing and product validation which may be associated with new product development and introduction.
• Lead a Cross Functional Project Team, providing design assurance support and expertise for development of new products through R&D/NPI.
• Participate and provide technical input in line with the product development process (PDP) and associated procedures.
• Ensure compliance at all stages of product development process (PDP).
• Support planning execution of design verification & validation activities.
• Support planning execution of risk management activities per ISO14971.
• Operate and carry out product testing as required to support process and design validation, product development, or in supporting investigations of customer returns or complaints.
• Carry out periodic reviews of internal and external standards and identify potential gaps which require action.
• Ensure compliance of integer owned devices to state-of-the-art regulatory standards which DA are assigned.
• Provide support of Integer’s Manufacturing Excellence and Market Focused Innovation Strategies.
• Participate in Site Hoshin Planning, Quality Planning, Validation master plans and associated quality improvement imperatives.
• Embed Quality within all that you do – “I own Quality.”
• Assure adherence to our Quality Management System (QMS), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of our quality KPI’s.
• Promote Associate Engagement through the adoption of standardized problem-solving methodologies, behaviour-based safety programs, and improvement idea and suggestion systems.
• Support systems & process optimization through adoption of principles of built-in quality.
• Perform other duties as needed and as directed by your line of supervision.

Benefits

• Base salary
• Cash-based incentive program
• 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.
• 80 hours (10 days) of company designated holidays per year
• Annual allotment of paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees