Plymouth, Minnesota, United States · On-site
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 ev…
Skills: Risk Management, ISO 14971, Design Verification, Design Validation, Root Cause Analysis
United States · Remote OK
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 ev…
Skills: Labeling Process Management, Change Control, UDI Database Management, Adobe InDesign, Adobe Illustrator
Brooklyn Park, Minnesota, United States · On-site
$19/hr–$27/hr
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 ev…
Skills: Assembly, Inspection, Blueprint Reading, Microscope Operation, Measuring Devices
Salem, Virginia, United States · On-site
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 ev…
Skills: Manufacturing Support, Medical Device Manufacturing, Collaboration, Innovation
Alden, New York, United States · On-site
$17/hr–$25/hr
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 ev…
Skills: Technical Drawing Reading, Computer Operation, Mechanical Aptitude, Failure Analysis, Troubleshooting
Chaska, Minnesota, United States · On-site
$121k–$178k/yr
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 ev…
Skills: Engineering Leadership, Manufacturing Excellence, Lean Practices, Strategic Planning, Project Management
Tijuana, Baja California, Mexico · On-site
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 ev…
Skills: Inventory Accuracy, Material Flow Management, Shipping and Receiving, Forklift Operation, ERP Systems
Alden, New York, United States · On-site
$28/hr–$41/hr
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 ev…
Skills: Electrical Troubleshooting, Controls Troubleshooting, CAD Software, Blueprint Reading, Tool Design
Salem, Virginia, United States · On-site
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 ev…
Skills: Machining, Manufacturing
Santo Domingo, Distrito Nacional, Dominican Republic · On-site
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 ev…
Skills: Visual Inspection, Dimensional Inspection, Functional Inspection, GD&T, Measurement Tools
Tijuana, Baja California, Mexico · On-site
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 ev…
Skills: Programming Languages, Equipment Integration, Medical Industry Validations, Root Cause Analysis, 5 Whys
Brooklyn Park, Minnesota, United States · On-site
$19/hr–$29/hr
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 ev…
Skills: Machine Operation, Equipment Set-up, Preventative Maintenance, Blueprint Reading, Visual Inspection
Santo Domingo de Guzmán, Distrito Nacional, Dominican Republic · On-site
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 ev…
Skills: Visual Inspection, Dimensional Inspection, Functional Inspection, GD&T, ISO 9001
Plymouth, Minnesota, United States · On-site
$120k–$177k/yr
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 ev…
Skills: Medical Catheter Design, Product Validation, Design for Manufacturability, DFMEA, Regulatory Strategy
Santo Domingo de Guzmán, Distrito Nacional, Dominican Republic · On-site
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 ev…
Skills: Visual Inspection, Dimensional Inspection, Functional Inspection, GD&T, ISO 9001
Santo Domingo, Distrito Nacional, Dominican Republic · On-site
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 ev…
Skills: Visual Inspection, Dimensional Inspection, Functional Inspection, GD&T, ISO 9001
Santo Domingo, Distrito Nacional, Dominican Republic · On-site
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 ev…
Skills: Visual Inspection, Dimensional Inspection, Functional Inspection, GD&T, ISO 9001
Tijuana, Baja California, Mexico · On-site
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 ev…
Skills: Sap, Mes, Supply Chain Management, Process Excellence, Medical Device Manufacturing
Ireland · Remote OK
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 ev…
Skills: Clinical Strategy Development, Medical Writing, Regulatory Submissions, Clinical Evaluation, Post Market Clinical Follow Up
Penang, Malaysia · On-site
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 ev…
Skills: Hoshin Planning, Value Stream Mapping, 5S, Standardized Work, Manufacturing Cell Design
Plymouth, Minnesota, United States • On-site
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The role involves leading risk management activities and performing quality engineering to ensure design controls and test requirements are met. Responsibilities include generating validation protocols, conducting root cause analyses, and maintaining risk management files for medical devices.
Requires a Bachelor's in Mechanical Engineering with 5 years of experience, or a Master's with 3 years of experience. Candidates must have specific expertise in ISO 14971, EU MDR/FDA submissions for Class 2 or 3 devices, and lean sigma quality tools.
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
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.
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.
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.
Candidates who do not meet the education requirement may be considered with 10+ years of relevant experience.
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
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.
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®.
Offices: 5830 Granite Pkwy, Plano, Texas 75024, US
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®.
Offices: 5830 Granite Pkwy, Plano, Texas 75024, US
