Validations/ Verifications Engineer

Role Descriptions:

Must Have Technical/Functional Skills

Desirable Skills:

Skills: EIS: Medical Device & Regulations ~EIS: New Product Development (NPD) Methodology and Management

Experience Required: 4-6

5+ years of work experience in medical device industry

Required:

· 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 experience

Preferred:

· 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 language
 

Roles & 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 regulations

Generic 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.