Our cutting-edge robotics client is commercializing a new generation of wearable robotic prostheses and orthoses—built upon ground-breaking research at MIT’s Biomechatronics Group. The commercial launch serves as a springboard into the multi-billion dollar market for lower-extremity applications of wearable robotic systems. The Company has the financial backing of top-tier firms, including General Catalyst, Sigma Partners and WFD Ventures.
We are seeking a talented Manufacturing Engineer who loveS tackling technical challenges and has a passion for making a big difference in the quality of life for many thousands of people.
We are looking for a hands-on Manufacturing Engineer that will be responsible for the investigation, analysis, development and application of manufacturing processes, which ensure all medical devices meet specification.
RESPONSIBILITIES AND REQUIREMENTS:
- Provide technical support, troubleshooting and guidance to production areas including process and test development and problem resolution working under minimal supervision.
- Design and conduct manufacturing related qualifications and validations; ensure all processes are properly validated prior to production.
- Interface with design engineering and production to effect product design changes and to introduce new products to manufacturing.
- Design equipment and processes to improve production methods and quality. This includes functional testing and mistake proof assembly techniques.
- Ensure all manufacturing documentation is adequate and complete. Manage engineering change process related to manufacturing specifications and equipment.
- Conduct special engineering projects as assigned including data collection and experimentation.
- Reduce scrap and downtime, and evaluate and recommend disposition of discrepant materials appropriately.
- Design and/or improve small tooling fixtures, design of product tests, inspections and manufacturing methods.
- Review and evaluate minor engineering changes and/or other specification requirements.
- Assurance of high level of compliance to FDA, QSR and ISO Quality Systems.
- Ability to identify and develop advanced manufacturing processes.
- Ability to set and maintain the proper rigor for new product developments and testing.
MINIMUM QUALIFICATIONS:
- Bachelor’s Degree in Electrical/Mechanical or Manufacturing Engineering or equivalent education and/or experience.
- 2 – 5 years related experience.
- Thorough knowledge of FDA Quality System Regulations and ISO Quality Stems Requirements.
- Familiarity with SPC, Experimental Design and Statistical Sampling Techniques.
For more information about this position, please contact:
Nancy Hopkins
p: 978.897.2055
e: nancy@hopkins.com
