5 days ago
Azzur Group of CA is seeking an experienced, well-rounded Sr. Manufacturing Engineer for specialized projects at medical device companies. This position will document, implement, and improve manufacturing processes in order to meet daily production schedules while enhancing productivity and product quality.Essential Job FunctionsResponsible for the validation and qualification of manufacturing equipment and processes using standard qualification methods (IQ/OQ/PQ).Manage the design, procurement, building and debugging of tooling, machinery and test equipment.Create Process FMEAs.Create, maintain and improve manufacturing assembly line, work flow processes, manufacturing plans and detailed work instructions.Provide product and process expertise to enhance manufacturability of new and existing products.Use Lean Manufacturing concepts to improve product quality, labor efficiency, and throughput.Individual should:Be innovative, resourceful, and work with minimal direction.Have excellent organization, problem solving, communication, and team leadership skills.Work effectively with cross-functional teams.Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. QualificationsB.S. in engineering or science.5+ years in a medical device manufacturing environment per 21 CFR 820 and ISO 13485.Strong working knowledge of FDA and cGMP regulations and documentation practices, including SOP creation.Experience generating and executing qualification protocols (IQ/OQ/PQ).Experience with process validation, generating acceptance tests and other criteria related to new process development.Strong analytical, problem solving and project management skills.Ability to work within a team and as an individual contributor in a fast-paced, changing environment.Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams.Multitasks, prioritizes and meets deadlines in timely manner.Strong organizational and follow-up skills, as well as attention to detail.Experience in tool and fixture design.Experience using Minitab.Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) certificates from American Society for Quality (ASQ) are a plus.Six Sigma Certification is a plus.Experience using CAD is a plus. This is a full-time position and is located in Irvine, CA. Only candidates currently living within a commutable distance to Irvine, CA will be considered. Azzur Core Values: Puts Others First...Have the Courage to Take Action.Take Personal Responsibilities.Have Fun! This employer participates in E-Verify.
Azzur Group is a partnership of companies and talented professionals strategically unified to better serve its customers. They offer a comprehensive service line designed to help businesses throughout every step of the system life cycle. Azzur Group offers consulting services and project resources within the quality assurance, laboratory, clinical, IT/IM, business processes, manufacturing, process engineering, operations and R&D settings. Azzur Group's experienced staff can help with requirements definition, vendor selection, configuration, implementation, testing & validation, calibration, certification and maintenance.
14 days ago
only 14 days until close