$200 - $300 Day
Monday to Friday
8 hour shift
Health insurance
Paid time off
Dental insurance
Vision insurance
401(k) matching
Qualifications
3-5 years’ work experience in the medical device industry and in a manufacturing environment
Experience breaking down high-level (e.g. device level) performance issues into addressable action items
Bachelor’s degree in engineering or related field
Good knowledge of FDA regulations, cGMP’s and ISO standards
Good oral and written communication skills
All employees must be fully vaccinated against Covid-19
Responsibilities
This person will work with manufacturing, product development and quality and will also be responsible for managing the transfer of products to production, including support of contract manufacturers to develop and improve processes for mission-critical products in an ISO 13485 environment
Activities will include a good understanding of BOMs, design for manufacturability, process design, process validation, assembly methods and design reviews
Proficient at protocol and report writing with respect to development of new processes and optimization/validation of existing processes
Ability to use SolidWorks for the design of fixtures
Ability to read, analyze, interpret and generate engineering drawings
Knowledge of manufacturing processes, including fabrication of plastics and metals
Assist in design, selection and validation of new tooling and equipment
Analyze production processes and metrics to include yield, capacity and capability
Provide technical support for production and quality
Ability to solve problems using structured methods
Participate in and/or lead risk analysis exercises, including process FMEAs
Understanding of quality statistical models and metrics (confidence/reliability intervals, DOE, regression/trending, SPC, t-Tests, acceptance plans)
Provide vendor/supplier support on technical issues
Communication
3 years
5 years
Manufacturing
8
In-person