Design Assurance Engineer III

Who are we?

Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEM’s (original equipment manufacturers) to enhance the lives of patients worldwide and a provider of high-end niche batteries for specialized applications in the energy, military, and environmental markets. We are guided by our six Values, including focus on Customers, Innovation, Collaboration, Inclusion, Candor, and Integrity. Working at Integer means you are part of a team passionately pursuing excellence in all that we do and always reaching for the next great achievement.

What you’ll do in this role:

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, process validation support for Integer owned products. DA support process development projects. You 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 in your organization. You will learn the application of design assurance and product test development and testing concepts in the design & manufacture of Integers product lines.

You 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.

Design Assurance Activities

• You will 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.

• You will 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.

Support Quality and Manufacturing Excellence Imperatives

• Provide support of Integer’s Manufacturing Excellence and Market Focused Innovation Strategies.

• Participation in Site Hoshin Planning, Quality Planning, Validation master plans and associated quality improvement imperatives.

• You embed Quality within all that you do – “I own Quality.” You are a standard bearer for Quality in everything we do at Integer, by assuring 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.

• Associate Engagement promoted 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.

You may perform other duties as needed and as directed by your line of supervision.

How you will be measured:

The specific measures listed below may be subject to change and are not intended to be an all-inclusive list.

• Safety is our highest priority; you will be an active supporter of the Integer Environmental, Health & Safety programs.

• You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.

• Quality – Achievement of site Quality KPIs

• Innovation and ideation are critical aspects of your role, and you will be expected to generate continuous improvement suggestions and support the implementation of them.

• Living the Integer Values in your day-to-day work and in your interaction with others both inside and outside of the organisation.

What sets you apart:

• Minimum Education:

  • At a minimum you have earned a bachelor’s degree in an engineering or related field and may have earned a master’s degree.

• You are technically seen as a very competent technical contributor, a recognition you have earned through 5+ years of progressive engineering and/or technically focused roles and experiences.

• Minimum Experience:

• Candidates who do not meet the education requirement may be considered with 10+ years of relevant experience.

• Specialized Knowledge:

• You have a strong technical and problem-solving foundation, and preferably 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),

• You will have an awareness of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)

• You will have good knowledge in Microsoft Office

• Specialized Skills:

• You will demonstrate a solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual.

• You will demonstrate competencies in both written and oral communications.

• For outside of US countries, you will demonstrate competencies in both written and oral English communications.

• You will maintain a calm demeanor that transcends the high energy, constantly changing production environment.

• You will possess a positive, can-do attitude with an underlying belief that failure is not an option.

• You will be required to have a strong working knowledge of Statistics and the use of Minitab and be considered as an SME for statistics.

Salary Range: $94,050 - $137,940