Position available to work on exciting early-stage ophthalmic device development projects. Successful candidate will be involved with all stages from feasibility to development and finally transferring product to manufacturing and should have relevant industrial experience to be able to perform duties listed below. Successful candidate should also have good scientific skills, a strong work ethic, and an innovative mind.
Provides input to product conceptualization and design and feasibility testing. Documents work in laboratory notebooks and Technical Reports.
Performs activities associated with the development of new ophthalmic lenses and devices in accordance with Design Control procedures.
Develops product specifications, manufacturing methods and procedures.
Conducts test protocols, verification and validation activities, and equipment qualifications.
Prepares test protocols and reports, verification and validation reports, and equipment qualification protocols. Responsible for producing product development documentation in accordance with Good Documentation Practice.
Represents R&D on cross-functional teams that are working on Quality-related projects.
Other duties as assigned.
EDUCATION & TRAINING • B.S. in Biomedical or Mechanical Engineering preferred.
EXPERIENCE • Experience with medical device sector, preferably in ophthalmology. • Knowledge of Design Control procedures and Quality systems preferred. • Demonstrated experience developing and transferring new products preferred.
SKILLS • Independent thinking in order to solve engineering problems. • Strong background in engineering techniques and methodologies. • Good analytical and problem-solving skills. • Knowledge of and ability to follow Design Control requirements. • Knowledge of validation and verification techniques. • Working knowledge of Solidworks preferred. • Self-starter and works well with others. • Good communication and organizational skills.