New Product Introduction Engineer

Integer Holdings Corporation; Salem (VA); Sur place; USD 85 000 - 110 000; Plein temps

Résumé du poste

Integer Holdings Corporation is seeking an engineer to apply general engineering methods in the medical device field and contribute to product and process improvements. You will ensure customer expectations are met with guidance from senior engineers while adhering to QMS, FDA regulations, and safety standards.

The role emphasizes independent work with occasional mentorship, collaboration across teams, and the ability to analyze data to support root-cause investigations and continuous

Qualifications

• Bachelor's degree in engineering or related technical field is required.
• At least 3 years of relevant experience; 7+ years if without a degree.
• Ability to work independently and with cross-functional teams.

Responsabilités

• Apply standard engineering methods and tools to develop in the medical device field.
• Ensure compliance with QMS, FDA regulations, and safety requirements.
• Review procedures and plans; perform failure analysis and propose improvements.
• Lead or contribute to projects introducing new product/process technologies.
• Perform root cause analysis to justify improvements and achieve quality KPI's.

Connaissances

General Engineering

Data Analysis

Root Cause Analysis

Quality Systems

Team Collaboration

Formation

Bachelor's degree in Engineering

Description du poste

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:

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.

• 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.

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 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.

What sets you apart:

• You earned, as a minimum, a bachelor’s degree in an engineering or related technical field; and have at least three years of relevant experience.
• Candidates who do not meet the education requirement may be considered with 7+ years of relevant experience.
• While you will have occasional support and guidance from more experienced engineers, supervisors or managers, you will demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams.
• You 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 have a functional understanding of the Integer Quality Management Systems and are able to complete required Quality System documentation tasks with little or no direction from others.
• You demonstrate competency in both written and oral communications.
• 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.