This is a 6 month contract to hire (potentially) position.
Here are the requirements for this position.
NPI IS A MUST HAVE
MEDICAL DEVICE OR OTHER REGULATED INDUSTRY A MUST HAVE
Bachelor's degree in engineering (Mechanical, Electrical, or related field) with 5+ years of experience, or Master's degree in Engineering with 8+ years of experience in a regulated industry.
• Strong experience developing manufacturing processes, for Electromechanical assemblies.
• Background in medical device or capital equipment manufacturing within a regulated industry.
• Proven ability to lead highly technical projects in a cross-functional environment.
• Extensive experience with root cause analysis (RCA) and problem-solving for both technical and process issues.
• Experience with BOM creation, management, and change control.
• Preferred experience with Salesforce, QAD, or similar systems for BOM and change management.
• Familiarity with structured design processes (ISO 9000, FDA QSR) and regulatory approval requirements.
• Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO 13485.
• Proficiency with CAD software (SolidWorks or similar).
• Excellent computer skills with specific skills in Microsoft Office and proficient in SolidWorks.