What are the responsibilities and job description for the Validations/ Verifications Engineer position at Katalyst Healthcares and Lifesciences?
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.
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.