NPI Engineer III

Who are we?

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®.

What You’ll Do In This Role

• 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 can advance technology beyond previous achieved levels.
• Apply engineering concepts to resolve acute or chronic problems.
• Carry out studies to understand capability for process and/or measurement systems.
• 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, 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
• Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
• Develop new test 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 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 which may be associated with new product introduction.
• Lead a Cross Functional Project Team, providing support and expertise for 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 risk management activities per ISO14971.
• Carry out periodic reviews of internal and external standards and identify potential gaps which require action.
• Lead continuous improvement projects.
• Assist with product transfers.
• 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.
• Create Test Methods
• 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 the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
• Support Non-Conforming Material Process
• Ensure that the 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, nonconforming 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 to support the justification for improvements to products and processes.
• Support Site Quality Activities
• Support internal quality audit activities, as applicable.
• 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.
• 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.
• Systems & Process Optimization through adoption of principles of built-in-quality.

How You Will Be Measured

• 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.

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.

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.

Pay

Salary: $86,250- $126,500

Benefits

• Total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success.
• 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.

Equal Opportunity Employer

In addition, veterans and individuals with disabilities are encouraged to apply.