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 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
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.
U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.
Skills Required
- Bachelor's degree in Mechanical Engineering or related field plus 5 years' experience, or Master's in Mechanical Engineering or related field plus 3 years' experience.
- Minimum 5 years (or 3 with Master's) experience using quality/Lean Six Sigma tools: Root Cause Analysis, QFD, Ishikawa, Kepner Tregoe.
- Experience performing Gage Repeatability and Reliability studies and Attribute Agreement Analysis for test method validation.
- Experience performing sourced item/component and supplier qualification and investigating non-conforming material, including review of schematics, drawings and design specifications.
- Minimum 4 years (or 2 with Master's) experience creating risk management files per ISO 14971 for Class II/III devices (EU MDR 2017 or 510(k) submissions).
- Minimum 4 years (or 2 with Master's) experience performing Design Verification and Validation (creating protocols, executing testing, generating reports) for Class II/III devices (EU MDR 2017 or 510(k) submissions).
- Experience generating and reviewing design verification/validation and process validation protocols and reports; maintaining risk management files for device lifecycle.
- Ability to determine appropriate statistical methods including sample size determination and conduct independent DHF and technical file reviews.
- Authorization to work permanently in the United States (must have authority to work permanently in the U.S.).
Integer Holdings Corporation Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Integer Holdings Corporation and has not been reviewed or approved by Integer Holdings Corporation.
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Leave & Time Off Breadth — PTO and paid holidays are often characterized as generous. Paid volunteer time further broadens time‑off options beyond core leave.
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Retirement Support — A 401(k) with company match and immediate vesting is highlighted. This structure provides accessible retirement savings support from the start.
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Parental & Family Support — Parental leave, adoption assistance, and family medical leave are included. Feedback suggests these offerings add meaningful non‑salary value for many roles.
Integer Holdings Corporation Insights
What We Do
Integer Holdings Corporation (NYSE:ITGR) is a leader in advanced medical device outsourcing (MDO) and serves its customers by providing comprehensive end-to-end solutions with its unparalleled expertise in innovation and manufacturing. Integer's vision is to enhance the lives of patients worldwide by being its customer's partner of choice for innovative medical technologies and services. Additionally, through Electrochem, an Integer company, it develops custom batteries for high-end niche applications in energy, military, and environment markets. The company's medical device manufacturing brands include Greatbatch™ Medical and Lake Region Medical™. Additional information is available at www.integer.net.
