Design Assurance Engineer I

Integer Holdings Corporation•Clarence, NY

1d•$58,800 - $85,800•Onsite

About The Position

The primary purpose of this role is to support the Design Assurance group in areas including Design verification, design Validation, statistics, risk management. test method development and standards, sourced item qualification, test method validation, design input requirements (spec generation), ensuring design outputs meets inputs, design transfer support, process validation support for Integer owned products. DA supports process development projects. As an entry level associate, 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.

Requirements

Bachelor’s degree in Quality, Engineering, or a related technical field
0 – 3 years of experience
Solid technical aptitude with the ability to be an effective contributor to the team or produce results of a technical nature as an individual.
Good working knowledge of Statistics and the use of Minitab.
Competencies in both written and oral communication.
Maintain a calm demeanor that transcends the high energy, constantly changing product environment.
Positive, can-do attitude with an underlying belief that failure is not an option.

Nice To Haves

Ability to work independently as well as collaboratively with other associates and cross functional teams.

Responsibilities

Under the supervision of experienced Design Assurance mentors and managers, you will select and apply standard engineering techniques and applicable procedures, to provide support in the aspects outlined below.
Under supervision, you will assist in the development of new test methods and in the improvement of existing methods including design and manufacture of new tooling, fixtures, and templates.
Assist in the 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.
You will be a member of a Cross Functional Project Team, providing design assurance support and expertise for the 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.
Under supervision, 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.
You are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support of your development as an engineer.
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.