Engineer, Senior - NPI*

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 job is to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields. The following are expectations: Ensure Integer internal and external customer expectations are met or exceeded. You Identify and evaluate procedures to ensure that NPI projects result in quality product. Develop new and unique approaches to complex problems and can advance technology beyond previous achieved levels. Apply engineering concepts to resolve acute or chronic problems. Conduct studies to understand capability for process and/or measurement systems. Provides management with technical guidance as required. Identify and develop appropriate documentation for process improvement and project implementation. Maintain liaison with individuals and units within or outside the organization with responsibility for acting independently on technical matters pertaining to their field. 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. NPI Support: You will support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality. You will coach and mentor others to develop new test methods including design and manufacture of new tooling, fixtures, and templates. Lead testing and validation of new test methods including gage R&R studies and statistical analysis of data through software packages such as Minitab. Create test method procedures and standard operating procedures as required. Lead and 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 NPI projects. You will review and approve procedures, protocols, reports and other documents related to test method development, process development and process validation which may be associated with new product development and introduction. Lead or coach a Cross Functional Project Team, providing NPI quality support and expertise for development of NPI projects. 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 risk management activities per ISO14971. Operate and carry out product testing as required to support process and process validation, or in supporting investigations. Carry out periodic reviews of internal and external standards and identify potential gaps which require action. You will lead in continuous improvement projects. You will lead product transfers. You may provide supervision for up to 3 engineering direct reports. As well, you will serve as a coach and mentor for other engineers, modeling the behaviors and disciplines of an engineering or technical professional. You will perform work on technical projects where you will follow Integer’s standard quality management and production system methodologies to investigate opportunities for product and process improvements. 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. Create Test Methods: You will lead the generation and completion of protocols and reports for test method validations. You will interface with Manufacturing Engineers to review processes for new products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable. You will develop various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval, and implementation of Incoming, In-Process and Final Inspection procedures. Support Non-Conforming Material Process: You will ensure that the disposition of non-conforming materials meet all necessary procedures and assure adequacy of corrective actions to prevent re-occurrence. You will lead plant CAPA activities, including analysis of data and trends in supplier quality, nonconforming material, training effectiveness, and root causes analysis. Leads and manage complaint investigations and remediation recommendations as needed. Works with suppliers, management, Engineers, and Manufacturing associates in the resolution of quality problems through capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc. You will apply standard data analysis practices and observe products and processes to establish root cause for product and process failures or to support the justification for improvements to products and processes. Support Site Quality Activities: You will support and lead internal quality audit activities, as applicable. You embed Quality– “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), supporting to corrective and preventive actions investigation and implementation, and contributing to the successful attainment of our quality KPI’s and journey to 5 Sigma. You may perform other duties as needed and as directed by your line of supervision. Support Integer’s Manufacturing Excellence and Market Focused Innovation Strategies: Strategy Alignment through Site Hoshin Plans, Quality Plans, Validation master plans, associated quality improvement imperatives, and regular updates to QA RA weekly and monthly metrics, supporting the walk to 5 sigma. Leadership of Sustained Change ensuring customer change notifications are initiated and completed, as necessary, and supporting continuous improvement activities as required. Standardization through workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs where applicable. Associate Engagement promoted through the adoption of standardized problem solving. methodologies, behavior-based safety programs, and improvement idea and suggestion systems. Systems & Process Optimization through adoption of principles of built-in-quality. 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. Adhere to all Integer Values: Customer, Integrity, Candor, Inclusion, Collaboration, Innovation You will have defined Goals and Objectives specifying key projects and expected milestones to achieve. Quality - Customer Direct Complaint Rate, NCR rate, Complaint Cycle Time, CAPA Cycle Time 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. What sets you apart: Minimum Education: At a minimum you have earned a bachelor’s degree in an engineering or related field. Preferably, you may also have a master’s degree. You are technically seen as a subject matter expert, a recognition you have earned through 7+ 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 15+ 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 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 While you will have regular support and guidance from more experienced engineers, supervisors or managers, you will demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams. 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. 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 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 Thanks for your interest in working on our team!!