Design Assurance Engineer I

Integer Holdings Corporation; Town of Clarence (NY); On-site; USD 59,000 - 86,000; Full time

Job summary

Integer Holdings Corporation is seeking an entry‑level Design Assurance Engineer to support verification, validation, and risk management for product development. You will learn design assurance concepts and contribute to test development, data analysis with Minitab, and process improvements. The role emphasizes adherence to QMS, FDA regulations, and collaboration with cross‑functional teams.

A bachelor’s degree in quality or engineering and 0–3 years experience are required. U.S.

Qualifications

• Bachelor’s degree in Quality, Engineering, or a related technical field.
• 0–3 years of experience in design assurance or quality engineering.
• Solid working knowledge of statistics and Minitab.

Responsibilities

• Assist in development and improvement of test methods and procedures.
• Support design verification, validation, and risk management activities.
• Generate investigation reports and contribute to root cause analysis.

Skills

Statistics

Minitab

Communication

Education

Bachelor's degree in Quality, Engineering, or related technical field

Tools

Minitab

Job description

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
Who are we? Integer Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMOs) in the world, serving the cardio and vascular, neuromodulation, and cardiac rhythm management markets. As a strategic partner of choice, we advance the goals of our medical device customers through industry‑leading engineering and manufacturing, with a relentless commitment to quality, service, and innovation. The company’s brands include Greatbatch Medical® and Lake Region Medical®.

What you’ll do in this role:

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.

Design Assurance Activities

• 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.

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 – “IownQuality.” 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 ofourqualityKPI’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 benot 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 othersboth inside and outside of the organisation.

What sets you apart:

You have earned, as a minimum, a Bachelor’s degree in Quality, Engineering, or a related technical field and between 0 – 3years of experience. While you will have regular support and guidance from more experienced Design Assurance associates, you will demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams. You will demonstrate a solid technical aptitude with the ability to be an effective contributor to the team or produce results of a technicalnature as an individual. You will be required to have a good working knowledge of Statistics and the use of Minitab. You will demonstrate competencies in both written and oral communication. You maintain a calm demeanor that transcends the high energy, constantly changing product environment. You possess a positive, can‑do attitude with an underlying belief that failure isnot an option.

Design Assurance Engineer Salary:

$58,800- $85,800

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 packagewith 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.

U.S. Applicants:

Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply. Integer Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMO) in the world, serving the cardiac rhythm management, neuromodulation, and cardio and vascular markets. As a strategic partner of choice to medical device companies and OEMs, Integer is committed to enhancing the lives of patients worldwide by providing innovative, high‑quality products and solutions. The company’s brands include Greatbatch Medical® and Lake Region Medical®.

Additional information is available at www.integer.net.

Integer HoldingsCorporation (“Integer”) is an equal opportunity employer. Wedonotdiscriminate based on race, color, sex, religion, national origin, and on any other protected characteristics. We celebrate our many differences and remain committed to providing an inclusive workplace free from harassment and discrimination. Integer does not discriminate against any applicants or employees because he or she is a disabled veteran, Armed Forces service medal veteran,recently separated veteran, or active‑duty wartime veteran, campaign badge veteran, referred to collectively as “ProtectedVeterans.” It is also the policy of Integer to employ and to advance in employment, all people regardless of their status as individuals with disabilities. All employment decisions are based only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, promotion, transfer, layoff, recall, termination, rates of pay or other forms of compensation, and selection for training, including apprenticeship, at all levels of employment. Additionally, Integer provides reasonable accommodations to qualified job applicants and associates who need them for medical or religious reasons.

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