Manufacturing Engineer

Purpose

Collaborate with Engineering and Quality staff to develop and improve process and documentation for Manufacturing.

Support Manufacturing, Supply Chain and Contract Manufacturers.

Responsibilities

• Responsible for transition of new product and processes from Engineering to Manufacturing, Supply Chain and Contract Manufacturers
• Help/monitor ramping up manufacturing at contract manufacturers
• Work with Engineering to troubleshoot manufacturing issues at contract manufacturers
• Monitor the yield
• Support all current products in terms of quality, manufacturing, supply continuity, and cost improvement.
• Implement corrective actions to address potential product deficiencies.
• Use Lean/six sigma methodologies to review/optimize mfg processes for efficiency improvement
• Be a liaison among Manufacturing, Engineering and Contract Manufacturers.
• Prepare production assembly instructions and production testing procedures in accordance with GMP standards.
• Create and implement DCR and train the team effectively
• Travel to Contract Manufacturers and suppliers as needed to support production.
• Evaluate new components due to component End of Life-ed or for cost reduction.
• Qualify/test new materials for patch assembly for cost reduction
• Qualify new CMs for risk mitigation and/or cost reduction
• Familiar with LabVIEW and/or Python is a plus

Qualifications

• Bachelor Degree in Computer Science, Electrical Engineering, Mechanical Engineering is preferred
• 5 years of experience, medical device industry experience is preferred.
• Experience with ISO 13485 and/or FDA 21 CFR Part 820 is preferred.

Salary & Benefits

The estimated hiring salary range for this position is $140,000-$160,000. The actual salary will be based on a variety of job-related factors, including geography, skills, education and experience. The range is a good faith estimate and may be modified in the future. This role is also eligible for a range of benefits including medical, dental and 401K retirement plan.