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 we are:
Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEM’s to enhance the lives of patients worldwide. Our two major business lines are as a Medical Device Outsourcer (including the businesses of Cardiac & Vascular, Cardiac Rhythm Management & Neuromodulation, and Power Solutions) and a provider of high-end. We are guided by our six values, including Customer, 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 will do in this role:
- 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.
- Manage and coordinate a production operation with low volume and/or multiple production teams/product lines which may include single or multiple shifts to ensure that production requirements, performance goals, and improvement objectives are achieved.
Accountabilities & Responsibilities:
- Participate in business development activities that develop/enhance customer relationships and close sales, including business case, risk and technical assessments, and customer communication in partnership with the commercial team.
- Manage people and develop talent consistently and within Integer Values, create an environment and culture where all Associates are able to contribute to their full potential and promote talent by developing individual growth and development plans and organizational succession plans.
- Serve as an integral member of the Site’s Leadership Team and contribute to the development of the Site’s Strategies and annual goals and objectives from which your Key Performance Goals/Targets are derived.
- Understand and adhere to Integer’s Values and all company policies, procedures, and work instructions defined in your training plan.
- Ensure compliance to the established Quality Management System and all Environmental, Health, Safety, and Security protocols.
- Ensure one/one time with your direct reports, regularly, to monitor performance and check in on progress to Individual Development Plans.
- Collaborate with the R&D and Product Development teams to appropriately prioritize Production’ resources and support for new product launches aligned with the established Product Development Process (PDP).
- Embed Quality within the Operations team – “I own Quality.” Be a standard bearer for Quality in everything we do at Integer, by assuring adherence to our QMS, facilitating corrective and preventive actions, and contributing to the successful attainment of our quality KPI’s and journey to 5 Sigma
- Recommends methods for improving efficiency and reducing waste of materials and utilities.
- Define the goals and objectives for your direct repots with supporting Key Performance Indicators (metrics in Safety, Quality, Delivery, and Productivity)
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Pilot Production
- Assume responsibility for all production activities across multiple production areas at our manufacturing site and accept accountability for delivering the Key Performance Goals/Targets established.
- Be a site champion for deployment of the systems and tools to optimize all production activities across the site.
- Embrace the Manufacturing Excellence culture based on the Integer Production System and its focus areas
- Participate in the development of production plans with representatives from other departments, such as Production, Planning, Continuous Improvement, Customer Service, and Materials to ensure that production performance standards meet customer requirements.
- Monitor the status of actual performance against the production plan; drive actions to address off standard performance.
- Aligns product(s), line(s) and shift(s) with master plant production schedule and material planning to meet production goals.
- Ensures full utilization and accuracy of Oracle, Reliance and other data systems in the Production, Quality Systems and business analysis process.
- Provides direction in the resolution of technical and production-related problems to assure completion.
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NPI
- Lead the NPI department in introducing new products to our pilot production
- Coordinates the detailed project plans, schedules of execution, and cost estimates for major manufacturing transfer projects; performs periodic cost and productivity analysis
- Maintains close relationships with internal and external customers, including account and technical sales managers, to ensure delivery time and capitalize on growth opportunities.
- You will be participating in risk analysis, specification creation, V&V and test plans, test protocols and reports as well as supporting IQ, OQ, PQ
- Updates and maintains BOM’s and routings. Conducts time studies of work/production areas and makes recommendations for balancing lines to improve productivity, throughput and eliminate waste.
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Maintenance
- Responsible for execution of all Production related maintenance, equipment, system and fixtures.
- Continues monitoring and maintenance of the site’s clean room.
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Continuous Improvement
- Develop and execute sustained Continuous Improvement processes
- May lead continuous improvement and lean implementation efforts.
- Performs analysis of production and related processes and makes recommendations on improvements and organization of continuous improvement activities.
How you will be measured:
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The specific measures listed below may be subject to change and are not intended to be an all-inclusive list:
- Customer – meeting customers completion dates and satisfaction
- People - Associate engagement, resource alignment, management
- Quality - Customer Direct Complaint Rate, NCR rate, Complaint Cycle Time, CAPA Cycle Time
- Delivery - On time and to fill delivery performance, Schedule/Takt attainment
- Process Improvements – Process analysis and improvements.
- Productivity - First pass yield, labor efficiencies, Throughput metrics
- Cost Improvement - Cumulative incremental savings recognized
- Cost Controls - Adherence to budget across production cost centers, overtime usage versus budget
What sets you apart:
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Minimum Education:
- Bachelor’s Degree in Manufacturing, Engineering or a Business-related discipline preferred, or a combination of education and 5-8 years of experience in manufacturing environments.
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Minimum Experience:
- 5+ years’ experience in a manufacturing environment, 5 of which are in a managerial capacity.
- Experience working in the Medical Devices Industry a distinct advantage
- Specialized Knowledge and Skills:
- Demonstrable people management and team building skills; successful track record of recruiting, developing and retaining high performing and engaged workforce
- New process development and new product launch system experience
- Working knowledge of capacity planning
- Kaizen, Lean manufacturing and continuous improvement preferred
- Demonstrated project management skills
- Hands on , working with technicians and different teams to manufacture products
- Confident communicator written and verbal (one-on-one and group).
- Accomplished track record in production environments where you owned the responsibilities for delivering results, particularly those KPIs noted above.
- First-hand experiences implementing and/or sustaining Manufacturing Excellence and Lean practices.
- A mastery of problem-solving skills and evidence that you are a critical thinker and thoughtful decision maker.
- Demonstrated financial acumen with the capability to navigate a typical Profit and Loss Statement, explain how the delivered results from this role can affect the site’s profitability, and previous experiences controlling inventories.
- A calm demeanor that transcends the high energy, constantly changing production environment.
- A well-developed skill set for planning, executing, and delivering projects on time and on budget.
- A positive, can-do attitude with an underlying belief that failure is not an option.
- Fluent spoken and written English is essential
- Experience working on ERP systems such as SAP, Priority or Oracle
- Experience in management of production schedules, reading technical documents and blue prints preferred. Knowledge of Lean Manufacturing and Quality Systems preferred. Must have strong computer skills, especially Microsoft office.
U.S. Applicants: EOE/AA Disability/Veteran
