Work on Quality System, including, but not limited to corrective & preventive actions, nonconforming materials, risk management, and medical device regulations.
Requirements:
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.
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:
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
Numbers & Facts
Location
Boston, MA
Skills
Bioengineeringunmatched
Blueprintsunmatched
Communication Skillsunmatched
Computer Skillsunmatched
Corrective Actionunmatched
Design Failure Mode and Effects Analysis (DFMEA)unmatched
Detail Orientedunmatched
Embedded Systemsunmatched
Engineeringunmatched
Follow Throughunmatched
Geometric Dimensioning and Tolerancingunmatched
Interpersonal Skillsunmatched
Leadershipunmatched
Lean Six Sigmaunmatched
Literacyunmatched
Materials Managementunmatched
Mechanical Engineeringunmatched
Medical Equipmentunmatched
Microsoft Excelunmatched
Microsoft Outlookunmatched
Microsoft Wordunmatched
Multitaskingunmatched
Organizational Skillsunmatched
People Managementunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Process Failure Mode and Effects Analysis (PFMEA)unmatched
Product Developmentunmatched
Product Testingunmatched
Quality Engineeringunmatched
Regulationsunmatched
Risk Managementunmatched
Team Playerunmatched
Technical/Engineering Designunmatched
Verification Engineeringunmatched
Writing Skillsunmatched
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