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Manufacturing Engineer

1 month ago

Plymouth, United States Integer Holdings Full time

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:

Responsibilities:
  • Supports ongoing production operations and is the primary technical support resource for production lines.
  • Typically, works directly with production associates daily to support process and equipment as well as responds to resolve technical issues that arise during production operations.
  • Develops, details, and implements process and equipment solutions which improve safety, quality, delivery and cost on existing production lines.
  • Develops and procures tooling, fixtures, and equipment used in manufacturing that optimize productivity, maintainability, and cost.
  • Creates and maintains manufacturing documents and digital operations systems (IIOT systems) including engineering drawings, BOMs, routers, process work instructions, engineering change orders, and MES configuration modeling.
  • Leads equipment qualification and process validation tasks. Collaborates with cross-functional teams to evaluate and influence designs for manufacturability, cost reduction and business growth projects.
  • Interacts with manufacturing, quality and supply chain associates to identify process improvement opportunities and to evaluate/disposition non-conforming products as needed.
  • Establishes and executes corrective and preventative action plans to remediate system quality or operational concerns and proactively takes action to mitigate potential for production operations failures.
  • Participate in cross-functional project teams to implement creative solutions.
  • Monitors performance of equipment, machines and tools and correct equipment problems or process parameters that produce non-conforming products, low yields or product quality issues.
  • Interfaces with Quality and R&D to integrate new products or processes.
  • Responsible for identifying and correcting manufacturing process nonconformance‘s identified during prototype builds.
  • Works with the product monitoring group on complaint investigations and supports the DPRA process.
  • CAPA owner for any CAPA‘s related to the design of the product. Coordinates with the manufacturing site on product transfers by leading the design transfer process.
  • Supports the manufacturing site on any design or process related changes.
  • Supports the supplier quality team on for supplier changes that might impact the product design.

The primary purpose of this position is to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields. Ensures Integer internal and external customers‘ expectations are met or exceeded.

  • 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.

  • You will develop new and unique approaches to challenging problems and work on projects that advance Integer‘s technological capabilities.

  • You will investigate and interpret internal or external technology and business trends and recommend best practices to the organization.

  • You will evaluate, develop and implement a wide range of new technologies of moderate scope and complexity.

  • You may identify and procure the new equipment and technology of moderate complexity, scope and cost.

  • You will originate new documents such as protocols, reports, specifications and work-instructions; and you may also review documentation work product of peers and others.

  • You will plan and develop engineering projects concerned with unique problems or team challenges, which have an important impact on moderate to large programs.

  • You may lead cross-functional teams or projects with minimal resource requirements, risk and or complexity and may begin developing the skills to influence others to achieve goals.

  • You will initiate and maintain relationships with individuals and business units within your site or organization.

  • You will be proficient in specialty areas or technologies and are building advanced skills to become a subject matter expert. As a result, you may be directed to deploy your expertise across multiple organizations and/or locations. As a result, occasional travel may be required in this position.

  • You embed Quality within the Engineering discipline - ‘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), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of our quality KPI‘s and journey to 5 Sigma.

  • You perform other duties, as needed and as directed by your line of supervision.

Provide support of Integer‘s Manufacturing Excellence and Market Focused Innovation Strategies

  • You champion the development of and deployment of the systems and tools to drive innovation and continuous improvement.

  • You embrace the Manufacturing Excellence culture based on the Integer Production System and its five focus areas:

    • Strategy Alignment through Site Hoshin Plans, the regular cadence of Sales, Inventory, and Operations‘ Planning (SiOP) meetings, and regular updates to the value stream maps.

    • Leadership of Sustained Change by ensuring production monitoring & improvement activities and deployment of Leader Standard Work.

    • Standardization through workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs.

    • 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, optimized scheduling & material system designs, work cell design, and total productive maintenance.

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.

  • Quality - Achievement of site Quality KPI‘s

  • You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.

  • Given your capabilities and experience, you will identify ways to shorten the project durations and make recommendations for systemic changes to current processes and procedures that enable greater efficiencies.

  • 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.

  • Your expertise coupled with your accomplishments and collaboration with others to deliver results will also be considered.

What sets you apart:

  • You earned, as a minimum, a Bachelor‘s Degree in an engineering or related technical field and may have earned a Master‘s Degree.

  • You are technically seen as a very competent technical contributor, a recognition you have earned through 5+ years of progressive engineering and/or technically focused roles and experiences.

  • Candidates who do not meet the education requirement may be considered with 10+ years of relevant experience.

  • 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), 8D, RCA, 5-Why, Ishikawa (Fish Bone), Kepner-Tregoe, PMP.

  • Your abilities to observe, analyze and develop solutions to challenging technical issues result in the delivery of measurable results in areas such as productivity, technical capabilities, capacities, or other competitive differentiators.

  • You work independently as well as collaboratively with cross functional teams.

  • You will demonstrate the ability to lead team activities and act as a coach for other less experienced associates.

  • Clear and professional communications to all levels of the organization are important in this role and you will have well-developed written and oral communication skills.

  • You maintain a calm demeanor that transcends the high energy, constantly changing production environment.

  • You possess a positive, can-do attitude with an underlying belief that failure is not an option.

U.S. Applicants: EOE/AA Disability/Veteran