As we continue to improve our product offering, we have an immediate need to augment the Manufacturing and Quality team with a Senior Manufacturing / Quality Engineer. This new addition will be responsible for the development and implementation of manufacturing processes, which ensure all medical devices meet specification. The successful candidate will participate in supplier quality and quality control functions, including supplier assessment/audits and resulting corrective actions, and establishing quality inspection criteria for incoming parts. In addition s/he will participate and provide leadership in compliance and continuous quality improvement as well as ensure that products (including services) are developed, manufactured, tested and delivered according to established procedures that will assure that they meet all quality requirements.
Ensure all manufacturing documentation is adequate and complete.
Manage engineering change process related to manufacturing specifications and equipment.
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 implement product design changes and to introduce new products to manufacturing.
Identify areas where equipment and process improvements will positively affect production methods and quality.
Review and evaluate minor engineering changes and/or other specification requirements.
Performs supplier audits and assessments, and follows corrective actions through to completion. Establishes and implements QC inspection criteria.
Perform internal audits of the Quality System.
Participate in CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root cause analysis.
Monitor manufacturing of assigned products, assuring compliance with DMR and assuring complete and correct Device History Records are maintained
Other duties as required.
Bachelor’s Degree in Electrical, Mechanical, Manufacturing Engineering or equivalent education and/or experience.
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.
Ability to work independently and in team environment.
Ability to effectively communicate written and verbally.
Other skills: Root cause analysis experience, technical understanding of electro-mechanical devices, process improvement techniques.
BionX is a wholly-owned subsidiary of Ottobock North America. Ottobock is the world leading developer of prosthetic and orthotic (O&P) components. BionX has taken ground breaking research in gait normalization, developed at the MIT Media Lab, and has turned it into a revolutionary prosthetic product for lower-extremity amputees.
The emPOWER ankle is a robotic ankle/foot system that emulates... the biological Achilles tendon and calf muscles and provides powered plantar flexion (push-off) during walking. The addition of this powered plantar flexion has been shown to normalize the metabolic energy used in walking between an amputee’s affected and disaffected sides.