Avantec Vascular is looking for a manufacturing/process engineer to improve and sustain production for medical devices. 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.
3-5 years’ work experience in the medical device industry and in a manufacturing environment.
Support transfer of new or improved products from Engineering to Production.
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 read and understand manufacturing instructions and standard operating procedures. 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. Experience breaking down high-level (e.g. device level) performance issues into addressable action items.
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.
Bachelor’s degree in engineering or related field.
Good knowledge of FDA regulations, cGMP’s and ISO standards. Good oral and written communication skills.