Senior Validation Engineer at 3D Systems

Posted in General Business 10 days ago.

Type: Full-Time
Location: Littleton, Colorado





Job Description:

Organization:

3D Systems Littleton, is a dynamic and leading enterprise, specialized in 3D Printing of metal and other material components. 3D Systems Littleton is not only a technology developer but also a technology user. This makes us a strong innovation partner for clients in the aerospace, industrial, medical and dental sectors.

JOB DESCRIPTION:

The 3D Systems site in Littleton, Colorado is expanding rapidly and needs a skilled Validation/Process Engineer as part of the Application Innovation Group. This role will be within the Application Innovation Group (AIG) under the direction of the Senior Validation Engineer. The mission of the team is to accelerate the development of advanced applications and innovative additive manufacturing solutions, for 3DS, for their clients and the society as a whole. We pull from technology, software, materials and service to offer unmatched solutions to our customers. Our pace of growth is only matched by the pace at which our customers expect their new and innovative products to be delivered.

The Validation Support Engineer is responsible for focusing interfacing with customers to help facilitate the implementation of process controls and validations as regulated by the ISO 13485, ISO 9001, AS9100 and global requirements such as FDA QSR, MDD and various aerospace regulations. This position is responsible for supporting the development and execution of manufacturing processes and quality systems in accordance with internal guidelines as well as customer driven requirements.

In this job, you will not only cooperate with your manufacturing, quality and application engineering colleagues world-wide but you can also rely on the knowledge and experience of colleagues from other 3D Systems divisions.

You are capable of assessing customer demand. Using a project management approach you define and deliver your projects in time and within budget. You will work closely with the Project Management Office collegues and AIG management to allocate resources, engage with customers and set internal teams up for success

Performance Objectives:

The following performance objectives will determine job success for this position:


  • Collaboration with project teams, including both internal and external stakeholders, as a contributing member by providing quality and process engineering support in the development of new products and processes using 3D Systems' products.
  • Application and process development of new technologies to enhance the capabilities of 3D Systems'
  • Contributing to the development and execution of verification & validation plans, testing, and generation of test protocols and reports
  • Detailed project assessment and project planning inclusive of gains, investments, resources, and timing.
  • Project leadership of initiatives across cross-functional teams
  • Development of 3D printing processes
  • Coordination and execution of process qualifications inclusive of IQ, OQ, and PQ.
  • Development and contribution to the risk management process
  • Development and contribution of process controls and planning
  • Participating in the compilation and review of technical documentation for both domestic and international regulatory submissions
  • Assisting project teams on compliance with design control requirements per FDA QSR, European MDD, ISO 13485/9001 and other applicable ISO/EN standards
  • Participating in the execution, maintenance and improvement of the Quality Management System.

This document represents the major duties, responsibilities, and authorities of this job, and is not intended to be a complete list of all tasks and functions. It should be understood, therefore, that incumbents may be asked to perform job-related duties beyond those explicitly described.
QUALIFICATIONS


  • Bachelor degree, preferably in engineering.
  • 3-5 years of related work experience in regulated, cGMP environment such as medical device, pharmaceutical or food manufacture.
  • Quality assurance and reliability experience supporting product development and/or manufacturing are preferred.
  • Experience in a highly regulated environment such as aerospace (AS9100) or medical device (ISO 13485) is a plus
  • Ability to read and design engineering specifications across a number of products and materials.
  • Ability to analyze and develop engineering processes for use in advanced technology implementations
  • A strong commitment to providing excellent customer service
  • Professional demeanor with excellent communication skills
  • Excellent computer skills

  • Ability to travel both domestically and internationally up to 50% of the time

Compensation and Benefits

  • Salary Range: $81,700 - $122,500 (salary to be determined by the education, experience, knowledge, skills, and abilities of the candidate, and alignment with market data).
  • In addition to a salary, this position is eligible for an annual bonus based upon company performance.
  • 3D Systems offers a comprehensive benefit package including medical, dental and vision coverage, company-paid short-term and long-term disability insurance, and company-paid basic life insurance. Sick Leave, Flex (Vacation) Time, Parental Leave, and paid time off for recognized holidays. 3D Systems also provides a 401(k) Retirement Savings Plan option with a company match.
Organization:

3D Systems Littleton, is a dynamic and leading enterprise, specialized in 3D Printing of metal and other material components. 3D Systems Littleton is not only a technology developer but also a technology user. This makes us a strong innovation partner for clients in the aerospace, industrial, medical and dental sectors.

JOB DESCRIPTION:

The 3D Systems site in Littleton, Colorado is expanding rapidly and needs a skilled Validation/Process Engineer as part of the Application Innovation Group. This role will be within the Application Innovation Group (AIG) under the direction of the Senior Validation Engineer. The mission of the team is to accelerate the development of advanced applications and innovative additive manufacturing solutions, for 3DS, for their clients and the society as a whole. We pull from technology, software, materials and service to offer unmatched solutions to our customers. Our pace of growth is only matched by the pace at which our customers expect their new and innovative products to be delivered.

The Validation Support Engineer is responsible for focusing interfacing with customers to help facilitate the implementation of process controls and validations as regulated by the ISO 13485, ISO 9001, AS9100 and global requirements such as FDA QSR, MDD and various aerospace regulations. This position is responsible for supporting the development and execution of manufacturing processes and quality systems in accordance with internal guidelines as well as customer driven requirements.

In this job, you will not only cooperate with your manufacturing, quality and application engineering colleagues world-wide but you can also rely on the knowledge and experience of colleagues from other 3D Systems divisions.

You are capable of assessing customer demand. Using a project management approach you define and deliver your projects in time and within budget. You will work closely with the Project Management Office collegues and AIG management to allocate resources, engage with customers and set internal teams up for success

Performance Objectives:

The following performance objectives will determine job success for this position:


  • Collaboration with project teams, including both internal and external stakeholders, as a contributing member by providing quality and process engineering support in the development of new products and processes using 3D Systems' products.
  • Application and process development of new technologies to enhance the capabilities of 3D Systems'
  • Contributing to the development and execution of verification & validation plans, testing, and generation of test protocols and reports
  • Detailed project assessment and project planning inclusive of gains, investments, resources, and timing.
  • Project leadership of initiatives across cross-functional teams
  • Development of 3D printing processes
  • Coordination and execution of process qualifications inclusive of IQ, OQ, and PQ.
  • Development and contribution to the risk management process
  • Development and contribution of process controls and planning
  • Participating in the compilation and review of technical documentation for both domestic and international regulatory submissions
  • Assisting project teams on compliance with design control requirements per FDA QSR, European MDD, ISO 13485/9001 and other applicable ISO/EN standards
  • Participating in the execution, maintenance and improvement of the Quality Management System.

This document represents the major duties, responsibilities, and authorities of this job, and is not intended to be a complete list of all tasks and functions. It should be understood, therefore, that incumbents may be asked to perform job-related duties beyond those explicitly described.
QUALIFICATIONS


  • Bachelor degree, preferably in engineering.
  • 3-5 years of related work experience in regulated, cGMP environment such as medical device, pharmaceutical or food manufacture.
  • Quality assurance and reliability experience supporting product development and/or manufacturing are preferred.
  • Experience in a highly regulated environment such as aerospace (AS9100) or medical device (ISO 13485) is a plus
  • Ability to read and design engineering specifications across a number of products and materials.
  • Ability to analyze and develop engineering processes for use in advanced technology implementations
  • A strong commitment to providing excellent customer service
  • Professional demeanor with excellent communication skills
  • Excellent computer skills

  • Ability to travel both domestically and internationally up to 50% of the time

Compensation and Benefits

  • Salary Range: $81,700 - $122,500 (salary to be determined by the education, experience, knowledge, skills, and abilities of the candidate, and alignment with market data).
  • In addition to a salary, this position is eligible for an annual bonus based upon company performance.
  • 3D Systems offers a comprehensive benefit package including medical, dental and vision coverage, company-paid short-term and long-term disability insurance, and company-paid basic life insurance. Sick Leave, Flex (Vacation) Time, Parental Leave, and paid time off for recognized holidays. 3D Systems also provides a 401(k) Retirement Savings Plan option with a company match.





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