Control Engineer

Integer Holdings Corporation; Salem (VA); On-site; USD 80,000 - 110,000; Full time

Job summary

Integer Holdings Corporation in Virginia seeks an engineer to apply general engineering methods and advanced techniques in the medical device field, with guidance from experienced engineers and managers. You will help ensure internal and external customer expectations are met or exceeded.

You will review procedures and plans, evaluate products and processes for failures, and participate in projects to develop and implement new technologies of moderate scope.

Qualifications

• Bachelor’s degree in engineering or related technical field and at least three years of relevant experience.
• Alternative: seven or more years of relevant experience without a degree.
• Ability to work independently and with cross-functional teams to support quality and process improvements.
• Solid technical aptitude and ability to contribute to quality system documentation.

Responsibilities

• Perform general engineering work with occasional guidance from senior engineers and managers.
• Review procedures and plans; evaluate products, processes, and materials for failures and improvements.
• Investigate, document, and implement new product and process technologies of moderate complexity.
• Plan, schedule, and execute engineering work; lead smaller scope projects when applicable.
• Apply data analysis to establish root cause and justify product/process improvements.
• Collaborate with others and communicate effectively to support development as an engineer.
• Embed quality within the engineering discipline and adhere to QMS and regulatory requirements.

Skills

Engineering methods

Data analysis

Root cause analysis

Team collaboration

Independent work

Education

Bachelor's degree in engineering

7+ years of relevant experience

Tools

QMS

FDA regulation knowledge

Job description

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.