Medical Device Engineer

LINQM is looking for a Medical Device Engineer.
Write, Develop, execute experiments and tests, create, validate, and improve product designs and Ownership in the process validation in (IQ - Installation Qualification) (OQ - Operation Qualification) (PQ - Performance Qualification) including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports. 80% Develop, update, and maintain technical content of risk management files 10% Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback. 10% Other incidental duties assigned by Leadership
Skills:
Proficiency in CAD (experience in SolidWorks preferred) Good computer skills in usage of MS Office Suite Experience with inspection methods and tools Basic documentation, communication, and interpersonal relationship skills Basic understanding of statistical techniques Previous experience working with lab/industrial equipment preferred Good understanding and knowledge of principles, theories, and concepts relevant to Engineering Good problem-solving, organizational, analytical and critical thinking skills Good understanding of processes and equipment used in assigned work Knowledge of and adherence to Quality systems Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Must be able to work in a team environment, including immediate supervisor and other team members in the section or group Ability to build stable working relationships internally
Keywords:
Education: Bachelor's Degree or equivalent in Engineering (Mechanical) or related field, 5 years experience related industry experience or; ***Engineer II Technical validation IQOQ Risk Management Doc Inspection equipment (kynce) Solidworks/3d modeling software