Validations/ Verifications Engineer

Role Descriptions:Must Have Technical/Functional SkillsDesirable Skills:Skills: EIS: Medical Device & Regulations ~EIS: New Product Development (NPD) Methodology and ManagementExperience Required: 4-65+ years of work experience in medical device industryRequired:· A bachelor's degree in Technical or Scientific discipline· 5+ years of work experience in medical device industry· Experience conducting Process Verifications / Validations· Experience conducting Design and/or Process Failure Modes Effects and Analysis· Excellent problem solving and decision-making skills· Interpersonal skills that foster collaboration as they relate to technical situations· Strong initiative and follow-through in executing project responsibilities, overcoming obstacles, and balancing multiple priorities effectively through strong technical and/or project leadership experience· Design Quality Engineering experience· Design Control experiencePreferred:· An advanced degree· A bachelor's degree in mechanical engineering or Bioengineering· New Product Development experience· Experience with Blueprint reading/literacy/inspection methods & techniques including GD&T· Strong experience with Design Excellence, Six Sigma, or Lean· Spanish as a second languageRoles & Responsibilities:· Conducting Process Verifications / Validations· Design and/or Process Failure Modes Effects and Analysis· Blueprint reading/literacy/inspection methods & techniques including GD&T· People Management: ability to ensure small delays don’t derail critical items and work with embedded team on site to ensure smooth implementation.· Strategic Mindset: ability to think bigger picture and work with Senior leadership on long term strategy for area/site.· Performing risk management, execute product testing· Work on Quality System, including, but not limited to corrective & preventive actions, nonconforming materials, risk management, and medical device regulationsGeneric Managerial Skills, If any:· Required to have good communication skills both written & verbal and be computer literate (Word, Excel, outlook Email - a must).· Strong interpersonal, organizational, written and oral communication skills· Dependable, somewhat assertive, reasonably organized, resourceful and communicative with an ability to adapt and learn quickly as well as follow verbal and written instruction, detail oriented.