ValuesBy 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’ successInnovation: We create better solutionsCollaboration: We create success togetherInclusion: We always interact with others respectfullyCandor: We are open and honest with one anotherIntegrity: We do the right things and do things rightWhat you’ll do in this roleThe primary purpose of this job is to apply intensive and diversified knowledge of engineering principles and practices to New Product Introduction (NPI) projects.Ensure Integer internal and external customer expectations are met or exceeded.Identify and evaluate procedures to ensure the production of quality product.Develop new and unique approaches to complex problems and 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, and provide 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.Adhere to Integer’s Values and all safety, environmental, security and quality requirements, including QMS, Safety, Environmental and Security Management Systems, FDA regulations, company policies, operating procedures, and other regulatory requirements.Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.Develop new test methods, design and manufacture 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 process 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 NPI team reviews.Review procedures, protocols, reports, and other documents related to test method development, process testing and process validation associated with new product introduction.Lead a Cross‑Functional Project Team, providing support and expertise for NPI.Ensure compliance at all stages of product development process (PDP) and support planning execution of risk management activities per ISO14971.Carry out periodic reviews of internal and external standards, identify potential gaps requiring action.Lead continuous improvement projects and assist with product transfers.Perform work on technical projects following Integer’s standard quality management and production system methodologies to investigate opportunities for product and process improvements.Collaborate with others, ask questions, and regularly check for understanding in support of development as an engineer.Lead the generation and completion of protocols and reports for test method validations.Interface with Manufacturing Engineers to review processes for new products and coordinate process validations and capability studies. Recommend process monitoring devices where applicable.Develop various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for writing, approval and implementation of Incoming, In‑Process and Final Inspection procedures.Ensure disposition of non‑conforming materials meets all necessary procedures and assure adequacy of corrective actions to prevent re‑occurrence.Participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, non‑conforming material, training effectiveness, and root causes analysis.Apply standard data analysis practices and observe products and processes to establish root cause for product and process failures or support justification for improvements to products and processes.Support internal quality audit activities, as applicable.Embed Quality—“I own Quality.” Assure adherence to QMS, support corrective and preventive actions investigation and implementation, and contribute to achieving quality KPI’s and a journey to 5 Sigma.Support Integer’s Manufacturing Excellence and Market Focused Innovation Strategies, including 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.Lead sustained change ensuring customer change notifications are initiated and completed, supporting continuous improvement activities.Standardize through workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs where applicable.Promote Associate Engagement through adoption of standardized problem solving methodologies, behavior‑based safety programs, and improvement idea and suggestion systems.Optimize systems & processes through adoption of built‑in‑quality principles.How you will be measuredSafety: Active supporter of the Integer Environmental, Health & Safety programs.Adherence to all Integer Values.Defined Goals and Objectives specifying key projects and expected milestones.Quality metrics: Customer Direct Complaint Rate, NCR rate, Complaint Cycle Time, CAPA Cycle Time.Innovation and ideation: Continuous improvement suggestions and support for implementation.What sets you apartMinimum Education: Bachelor’s degree in an engineering or related field (Master’s preferred).Minimum Experience: 5+ years of progressive engineering and/or technically focused roles. Alternatively, 10+ years of relevant experience if education requirement not met.Specialized Knowledge: Strong technical and problem‑solving foundation, training/certifications in problem‑solving and project management methodologies such as Six Sigma (green belt minimum, black belt preferred), awareness of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, MDD, TGA, etc.), good knowledge of Microsoft Office.Specialized Skills: Solid technical aptitude, effective contributor to a team or individual results, strong written and oral communications, calm demeanor in high‑energy environments, positive can‑do attitude, strong working knowledge of statistics and Minitab, considered SME for statistics.Equal Opportunity EmployerU.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, or any other protected characteristics. Integer does not discriminate against any applicants or employees because they are a disabled veteran, Armed Forces service medal veteran, recently separated veteran, or active‑duty wartime veteran, campaign badge veteran, or any other protected veteran status. Integer employs and advances all people regardless of disability status. All employment decisions are based only on valid job requirements. Integer provides reasonable accommodations to qualified applicants and associates who need them for medical or religious reasons.
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