Validations/ Verifications Engineer

Skills

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

Required

• 4-6 years of work experience in medical device industry
• 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
• 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

• Good communication skills both written & verbal
• Computer literate (Word, Excel, outlook Email - a must)
• Strong interpersonal, organizational, written and oral communication skills
• Dependable, somewhat assertive, reasonably organized, resourceful and communicative
• Able to adapt and learn quickly as well as follow verbal and written instruction, detail oriented