Staff Engineer

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 experience
• Good 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