Senior Engineer

Senior EngineerLead identification, development, and optimization of manufacturing processes using engineering methods for continuous process improvement initiatives. Identify opportunities & implement solutions for re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes and reduce overall process/product risk profile. Monitor critical control points. Drive the development and manage the execution of experiments and tests to improve products and establish robust manufacturing processes/test methods based on engineering principles; ensure completion of process validations, including analyzing results and developing reports; collaborate with cross-functional team members to facilitate project success and on-time completion. Collaborate with engineers for equipment selection and validation. Develop training and documentation materials for production and receiving inspection to enable the seamless knowledge transfer of project and manufacturing processes. Develop and sustain technical content of risk management files. Lead in the investigation of complex manufacturing product quality and compliance issues for all production processes and based on engineering principles; analyze results, make recommendations and develop reports. Oversee quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/technicians and operators and provides feedback; and may coordinate engineers/technician work. Lead, review and approve compliant change control.Preferred: ASQ Certified Quality Engineer (CQE) Six Sigma Green Belt or betterRequired Skills: Proven expertise in usage of MS Office Suite Ability to read and interpret drawings Proven expertise in statistical techniques Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills Ability to translate technical information to all levels of the organizations Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge) Knowledge of Six Sigma concepts with ability to apply to work product Knowledge of Quality Engineering concepts with ability to apply to work product Problem-solving, organizational, analytical and critical thinking skills Understanding of processes and equipment used in assigned work Strong leadership skills and ability to influence change Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Work is performed independently Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts Experience with automation, software testing, and software validation is strongly preferredEducation/Experience: Bachelor's degree in engineering required. 5-7 years of experience required.