Sr. Manufacturing Engineer
$115k - $125kLighteum Medical
Sr. Manufacturing Engineer Salary Range: $115,000 to $125,000 Location: This is an onsite position based at the Company's San Diego facility. Job Purpose This position is responsible for providing technical support to various production departments and leading critical site improvement and expansion projects. The engineer builds a deep understanding of Lighteum’s operations—including technical aspects of the processes, the Voice of the Customer reflected on the quality requirements, and the Voice of the Business—to make sound decisions that improve our processes. Principal Accountabilities Provide technical support to manage change and troubleshoot problems, coaching other engineers on problem solving and project management. Design and improve existing tooling and equipment used in production and validate such equipment using standard medical device industry techniques. Work with the NPI engineering group to support the transfer of new technologies and products from Development to Production. Lead the development, improvement, and strategy of accountable areas; own key site metrics on the site scorecard. Oversee and lead work of other Engineers. Apply Lean principles to drive process improvements across departments and support ongoing Kaizen/Process improvement projects. Develop capital equipment justifications for new machines or processes that support site goals of increasing quality, cost, and/or cycle time. Manage capital equipment projects, including budgeting, equipment validation (IQ/OQ/PQ), and effective transfer to production. Follow quality policy, quality objectives, and applicable Quality Operating Procedures and QS requirements, complying with ISO standards. Participate in local programs to sustain and improve EHS performance. Identify and validate appropriate metrology tools and inspection methods to verify product conformance per Measurement System Analysis (MSA) requirements. Characterize, optimize, and validate equipment and processes based on statistical experimentation. May travel 5% of the time based on assigned projects. Scope The Sr. Manufacturing Engineer reports to the Site Director and interacts regularly with all other departments on site. The role works with New Production Introduction, Operations, Quality, and Supply Chain to support site objectives and may design and manufacture specialized production equipment and mistake-proofing tools as needed. Person Specification To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below represent the essential knowledge, skills, and abilities needed. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Qualifications / Knowledge / Experience Minimum 5 years’ experience in a manufacturing environment. Experience in the medical device industry. Working knowledge of Lean Manufacturing and Six Sigma. Ability to operate manufacturing machinery such as bench grinder, mill, lathe, laser. Proficiency in Office 365 and related software. Proficiency in Minitab or other statistical software. Proficiency in data analysis and presentation (Power BI preferred). Proficiency in CAD/CAM (Solidworks, MasterCam, & Esprit preferred). Ability to occasionally lift 10–20 pounds. Personal Skills and Key Competencies Continuous Improvement – Originating action to improve existing conditions and processes; identifying opportunities, generating ideas, and implementing solutions. Planning & Organizing – Establish courses of action for self and others to ensure work is completed efficiently. Initiating Action – Taking prompt action to accomplish objectives and exceeding required duties proactively. Communication – Clearly conveying information and ideas through various media to individuals or groups, engaging and helping them understand and retain the message. Safety Awareness – Identifying and correcting conditions that affect employee safety; upholding safety standards. We are an equal opportunity employer and welcome applicants from all backgrounds. #J-18808-Ljbffr
$125.3k - $187.9k
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