$150K — $200K *
A bachelor’s degree in Mechanical Engineering is required and an advanced degree is preferred, along with 8 plus years of relevant experience in the medical device field.
This unique individual will have project planning and project management experience as well as product design, documentation, and the ability to perform risk analysis. You will actively participate in all phases of the product development process, from idea creation through to transfer to manufacture. You will design plastic components for hand-held, patient operated medical devices using SolidWorks 2013, Surfacing and FEA tools such as COSMOSWorks and Mold Flow. Device designs will incorporate complex mechanical mechanisms, reliability, esthetics, ergonomics, human factors, and cost, as well as select sound techniques to solve problems and improve existing products/processes. You will work with suppliers and molders in the design of injection molded components along with testing, analyzing, and solving engineering product development problems. He/she will assess designs for validity and conformance to specifications.
Documentation will also be an important part of the engineer’s responsibility. You will maintain product files and other relevant documentation to comply with design control and quality standards requiring a thorough understanding of regulatory guidelines for medical device design, cGMP manufacturing (21 CFR parts 210 & 211) and working knowledge of Quality System Regulation (Part 820)
Weekly meetings for document design reviews, FMEA, and update meetings will be the engineer’s responsibility. Additional responsibilities will include utilizing lab equipment, prototype builds and testing, assist in developing test methodologies and design/develop fixtures to aid in the assembly and production.
Mystic Pharmaceuticals is an exciting, fast paced company. We embrace a corporate culture of applied innovation, personal responsibility, integrity and a sincere desire to improve the quality of human life.
Valid through: 12/15/2020