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Integer Holdings Corporation is seeking an experienced engineering leader with a strong background in medical device manufacturing and quality/regulatory systems. The role emphasizes leading process validations, Lean improvements, and cross-functional collaboration to meet stringent quality standards.
The ideal candidate will have 10+ years of experience, a BS in engineering/technical field (MS/PhD preferred), and Six Sigma Black Belt certification.
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.
Adheres 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. Responsible for identifying, tracking, resolving, and communicating major new product ramps and cost reduction initiatives at a facility. Leads the development and implementation of Quality and Regulatory requirements including Integer policies, procedures, and appropriate regulatory requirements. Plans, Develops, and ensures resources are adequate to execute Process and Test Method Validations (IQ, OQ, PQ, PPQ) in accordance with Integer procedures and guidelines. Communicates procedures, policies, improvement ideas, technical information, and recommendations clearly, effectively and frequently (oral and written) within Integer, with outside suppliers or partners and with Integer customers during formal and informal interactions. Prepares or reviews documentation with a high degree of accuracy, completeness, and effectiveness using common Integer engineering tools & templates were available. (Examples include specifications, manufacturing procedures, ECOs, and technical reports or analysis). Using Lean Leadership experience, applies and Promotes Lean manufacturing techniques to continuously improve cycle times and process flows. Identifies and directs the execution of improvement efforts to reduce waste in all manufacturing and business processes. Uses structured problem solving techniques and statistical methods for data driven analysis and decisions. Using Black Belt experiences, leads DMAIC – Six Sigma approaches to solve issues and reduce variation in all manufacturing and business processes. Plans, executes and manages project activities with cross functional teams including finance, human resources, operations, quality and sales. Project types can include new product development and introduction, manufacturing transfers, continuous improvement and cost reduction initiatives, quality improvements and sales opportunities. Demonstrates leadership through mentoring of junior staff, responsiveness to business needs and motivation of diverse, cross functional teams including influencing both internal and external members to achieve positive business results. Leads staff performance management activities to improve capabilities and skills using regular objective setting and review process, performance appraisals and coaching of individual development plans. Demonstrates technical ability through the application of engineering skills, approaches and knowledge. Performs other duties as required.
130,350-191,000
U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.
Integer Holdings Corporation (“Integer”) is an equal opportunity employer. We do not discriminate 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 "Protected Veterans". 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, demotion, 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. If you are interested in applying for an employment opportunity with Integer and believe you will need an accommodation for the application or job interview processes, please contact us at +716-759-5631 or via TalentAcquisition@integer.net so that we may discuss appropriate adjustments to our processes to enable you to be considered for a job opening. This phone number and email address is strictly for the purpose of making a request for an accommodation. Status updates on your application cannot be provided to you through this phone extension or email. For status updates, please log in to https://integer.wd1.myworkdayjobs.com/en-US/External/login For remote eligible job postings, all work should be performed entirely outside of Alaska, California, Hawaii, Maine, Montana, and Washington. To review the Integer Applicant Global Privacy Statement, please click link below for your preferred language: English| Spanish| Malay| Chinese.
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 Holdings Corporation (“Integer”) is an equal opportunity employer. We do not discriminate 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 "Protected Veterans". 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, demotion, layoff, recall, termination, rates of pay or other forms of compensation, and selection for training, including apprenticeship, at all levels of employment.
Thanks for your interest in working on our team!!