Provision Healthcare

campus

Leadership

Careers

ProNova Solutions – Engineering Change Analyst

The Engineering Change Analyst II will be responsible for administering, supporting, analyzing, and managing the potential impact of engineering changes on the supply chain, production environment and install base. This position will establish and maintain change management policies and processes, and will ensure enforcement of these processes through monitoring and evaluation as well. The Engineering Change Analyst will also evaluate change requests for completeness and accuracy, assess for risk and impact, and communicate results and recommendation to management and appropriate team members.

JOB RESPONSIBILITIES:

  • Responsible for establishing and managing engineering change policies and procedures, as well as enforcement and improvement the engineering change process.
  • Facilitate the Change Notification process used for updating product. This includes evaluating change requests for completeness, accuracy, relevance, and risk level. Ensure that all changes are approved and managed through the change management process and manage any non-compliances.
  • Develop and/or integrate best practices for change and release management into the supply chain, production, and install base. Monitor and coordinate Engineering Change activity as identified by engineering, service, and manufacturing.
  • Communicate manufacturing, inventory and logistics concerns to cross-functional teams early in the lifecycle to prevent problems in production of the product.
  • Monitor prototype changes to production release, ensuring that change documentation adequately describes the change and meets FDA guidelines.
  • Maintain accurate and thorough records either electronically or hard copy on all engineering documentation to ensure accurate product builds, part ordering and product updates.
  • Work with the Technical Training department to develop and deliver training for best practices, processes, and procedures in regards to the defined change management processes.

JOB SPECIFICATIONS:

  • Bachelor’s Degree in Engineering or in a relevant discipline, with 5 years’ experience working in a document control or engineering services environment.
  • Proven leadership abilities in a cross functional environment with solid demonstration of conflict management skills.
  • Engineering or manufacturing background, plus familiarity with manufacturing processes used to produce components and assemblies in a FDA regulated environment. Medical device experience is preferred.
  • Ability to work with minimal supervision with strong knowledge and experience in Configuration Management systems and processes.
  • Strong working knowledge of Product Lifecycle Management (PLM) requirements and the impact to documentation control. Must understand documentation needs and processes and be a strong policing agent to enforce those processes.
  • Excellent problem solving skills with the ability to be flexible, yet not compromise the integrity of corporate processes and solutions implemented. Creative thinker with strong written and verbal communication skills required.
  • Detail-oriented with understanding of engineering product development needs and ability to incorporate processes and procedures to support those needs.
  • Sound knowledge of ISO13485 requirements.
  • Proficient with MS Office (Word/Excel/PowerPoint and Outlook), Solidworks and AutoCAD. Agile PLM experience and administration a plus.
  • Ability to solve practical problems and deal with a variety of variables in ambiguous situations where only limited standardization and structure exist. Ability to use and demonstrate statistical and problem solving tools is required.