What you will do:
• Lead the effort to perform root cause analyses, resolve and implement product fixes, modifications, and design enhancements.
• Drive design optimization at the intersection of material, process, manufacturing and clinical considerations.
• Provide engineering support for component obsolescence issues and product compliance to standards.
• Drive Change management and lead product testing as required.
• Support/Lead the transfer of new products from engineering to manufacturing
• Conduct or design advanced prototyping and testing
• Be proficient with and mentor others in usage of industry standards, including design requirements and test strategies per applicable regulations
• Lead creation and refinement of engineering documentation, such as the Design History file, BOM, drawings, and procedures.
What you will need-
Required-
Minimum Qualifications (Required):
Bachelor of Science in Engineering, Mechanical Engineering or BioMedical & 7.5+ years of work experienceGood understanding of medical device product development, risk management methodologies, dfmea, DIOVV etc.Strong technical ability in creating engineering drawings, models, sampling plans, Design Verification Plan and Report.
Preferred Qualifications (Strongly desired):
• Adept at applying knowledge of materials, statistics and manufacturing processes to product design
• Ability to communicate moderate complexity plans and technical information to team members
• Project management and strong organizational skills
Travel Percentage: None