Validation Engineer

3 weeks ago

Buffalo Grove, United States Sterling Engineering Full time

Position Summary:

Provide technical support and required validation documentation to the commercialization of new medical device products, processing methods and technologies. Apply risk-based assessments and project management principles to technological initiatives. Research, develop and implement advanced technologies and automation across the entire value stream.

Essential Job Functions:

· Provide technical support to the commercialization of new medical device products, processing methods and technologies from development to manufacturing execution into Production departments.

· Collaborate with stakeholders and regulatory compliance to author required validation protocol documentation (IQ/OQ/PQ).

· Research, develop and implement advanced technologies and automation across the entire value stream.

· Apply risk-based assessments and project management principles to technological initiatives.

· Support continual improvement with the investigation and determination of root causes to product and process nonconformances.

· Closely interface with production support and maintenance departments on preventative maintenance programs.

· Generate and assist in the development of engineering plans and the designs required for cost reduction, process, and equipment improvements (User Requirement Specification (URS) and Functional Requirement Specification (FRS)).

· Pursue innovation in materials, methods and designs and incorporate them into long-term strategic plans.

· Other related duties as assigned.

Education, Knowledge, Skills, and Abilities:

Education / Certifications

· BS in Engineering (Chemical, Mechanical, Manufacturing, Industrial and/or Plastics) is preferred

· Certification in a related discipline is a plus

Knowledge/Experience

· 5 years of progressive product/process development and manufacturing experience inclusive of: processing of plastics, packaging design, medical products, and high-speed automation.

· Application of project management principles (scope and budget development, stakeholder communication plans, stage gate reviews and task tracking against timeline)

· Knowledge of Process Failure Mode Effects Analysis (PFMEA), root causes assessments (6 M’s Fishbone) and designed engineering studies (DOE).

· Good Practice Guidelines (GxP) and medical device manufacturing experience is preferred.

Skills

· Working knowledge of PLCs, AutoCAD, SolidWorks, Microsoft Project and Microsoft Office.

Abilities

· Ability to lead projects and to clearly communicate status, technical data, subsequent actions, and timelines to team members and senior management.

· Team-based collaborative abilities to interface cross-functionally production, planning, quality and engineering opportunities for improvement

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