Product Development Engineer II

Integer Holdings Corporation•Clarence, NY

1d•$70,500 - $103,400•Onsite

About The Position

The primary purpose of this position is to perform work which involves general engineering methods and tools; but you may also utilize more advanced technologies and engineering concepts while you are developing in your role as an engineer in the medical device industry. In this role, you will ensure that Integer’s internal and external customer expectations are met or exceeded with occasional direction, instruction and guidance from more experienced engineers and managers in your organization. Initiates, directs and manages the design, and development of new products and processes from concept to commercial manufacturing. Works closely with other departments to coordinate design engineering activities. Reviews, initiates or approves engineering drawings, layouts, changes orders and specifications. Plans process flow, evaluates process capability, modifies tooling, builds tooling, and designs tooling. Plans, schedules, conducts or coordinates detailed phases of the engineering work in a part o f a major project. Develops and /or reviews test procedures and plans prior to implementation, as well as conduct failure analysis and inspection on products, processes and materials. Evaluates, selects, and applies standard engineering techniques and procedures while using judgment when making minor adaptations and modifications. Devises new approaches to problems encountered. Prepares all necessary paperwork and documentation for all projects undertaken. 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 generally work independently with occasional guidance from supervisors or mentors to evaluate, select and apply standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications to existing specifications, procedures, and work instructions. You will review procedures and plans prior to implementation as well as evaluate existing products, processes and materials for failure analysis and potential improvements. You will participate in projects that require you to investigate, develop, document and implement new product and process technologies of moderate complexity and scope. While often you may be responding to situations presented to you by others, you will also be able to demonstrate proactive insight into technical challenges and mitigates potential issues or incorporates improvements. You will plan, schedule and execute the engineering work in a part of a major project; or you may lead a smaller scope project. 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 will apply standard data analysis practices and techniques to establish root cause for product and process failures or to support the justification for improvements to products and processes. You will be required to observe products and processes to recognize discrepancies in results and follow operations throughout a series of detailed steps or processes to establish root cause of the discrepancies. 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. 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 may 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.

Requirements

Bachelor’s degree in an engineering or related technical field, or 7+ years of relevant experience.
At least three years of relevant experience.
Ability to work independently as well as collaboratively with other associates and cross functional teams.
Solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual.
Functional understanding of the Integer Quality Management Systems.
Ability to complete required Quality System documentation tasks with little or no direction from others.
Competency in both written and oral communications.
Maintain a calm demeanor that transcends the high energy, constantly changing production environment.
Positive, can-do attitude with an underlying belief that failure is not an option.

Responsibilities

Initiates, directs and manages the design, and development of new products and processes from concept to commercial manufacturing.
Works closely with other departments to coordinate design engineering activities.
Reviews, initiates or approves engineering drawings, layouts, changes orders and specifications.
Plans process flow, evaluates process capability, modifies tooling, builds tooling, and designs tooling.
Plans, schedules, conducts or coordinates detailed phases of the engineering work in a part of a major project.
Develops and /or reviews test procedures and plans prior to implementation, as well as conduct failure analysis and inspection on products, processes and materials.
Evaluates, selects, and applies standard engineering techniques and procedures while using judgment when making minor adaptations and modifications.
Devises new approaches to problems encountered.
Prepares all necessary paperwork and documentation for all projects undertaken.
Adheres 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.
Generally works independently with occasional guidance from supervisors or mentors to evaluate, select and apply standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications to existing specifications, procedures, and work instructions.
Reviews procedures and plans prior to implementation as well as evaluates existing products, processes and materials for failure analysis and potential improvements.
Participates in projects that require you to investigate, develop, document and implement new product and process technologies of moderate complexity and scope.
Demonstrates proactive insight into technical challenges and mitigates potential issues or incorporates improvements.
Plans, schedules and executes the engineering work in a part of a major project; or may lead a smaller scope project.
Performs 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.
Applies standard data analysis practices and techniques to establish root cause for product and process failures or to support the justification for improvements to products and processes.
Observes products and processes to recognize discrepancies in results and follows operations throughout a series of detailed steps or processes to establish root cause of the discrepancies.
Collaborates with others in the exchange of information, asks questions and regularly checks for understanding in support of your development as an engineer.
Embeds Quality within the Engineering discipline – “I own Quality.”
Acts as 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.
May perform other duties as needed and as directed by your line of supervision.
Provides support of Integer’s Manufacturing Excellence and Market Focused Innovation Strategies.
Champions the development of and deployment of the systems and tools to drive innovation and continuous improvement.
Embraces 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.
Leads Sustained Change by ensuring production monitoring & improvement activities and deployment of Leader Standard Work.
Drives Standardization through workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs.
Promotes Associate Engagement through the adoption of standardized problem solving methodologies, behavior-based safety programs, and improvement idea and suggestion systems.
Drives Systems & Process Optimization through adoption of principles of built in quality, optimized scheduling & material system designs, work cell design, and total productive maintenance.