Description:

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

Requirements:

Qualifications

Bachelor Degree in Computer Science, Electrical Engineering, Mechanical Engineering is preferred 3+ 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 $100,000-$120,000 . 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.