Sr. Manufacturing Engineer (Thousand Oaks, CA)

JOB SUMMARY:

The Sr. Manufacturing Engineer will perform technical leadership and engineering activities to ensure medical device projects comply with applicable regulatory requirements and quality standards. This role focuses on leading complex, cross-functional projects, including establishing new process/operation lines, retrofitting equipment, and supporting audits and regulatory submissions. The Senior Manufacturing Engineer will act as a technical lead for Quality, Manufacturing, EHS, Procurement, Facilities, and Project Management teams. Responsibilities include sustaining and improving current manufacturing operations, leading root cause investigations, and driving continuous improvement initiatives. This position requires strong project management skills, technical depth, and the ability to manage multiple priorities in a regulated medical device environment.

ESSENTIAL DUTIES:

• Lead cross-functional engineering projects to establish new product lines, vendor sourcing and evaluation, procurement of all required components, facility coordination, and SOP development for operator training.
• Lead and execute CAPA, root cause investigations, and process improvement efforts related to cleanroom, shop floor, CNC, labeling, supply chain, and procurement operations.
• Collaborate with molding vendors, leading mold-related improvement projects including mold repair, design enhancements, and validation.
• Collaborate with CNC shop floor for CNC machining improvements, cycle time reduction, SMED events and set up time reduction and process improvement
• Develop and implement manual fixtures, assembly methods, and equipment improvements for manufacturing and labeling processes.
• Retrofitting and innovating equipment such as labeling and capping machines to support operational efficiency.
• Support SAP configuration, router creation, and the development of standardized work instructions and procedures.
• Facilitate and lead Kaizen events and continuous improvement initiatives across various manufacturing functions.
• Assist in all audit activities, including BSI Micro audit, ISO, and regulatory audits, serving as a subject matter expert in manufacturing processes.
• Collaborate with Project Managers on diverse engineering initiatives, learning and contributing to unfamiliar scopes as needed.
• Support of company's strategic plan
• Responsible for designing new processes and improving and maintaining existing processes
• Establish requirements and specifications for these processes
• Use experimental and numerical analysis to evaluate designs, NCMRs, issues
• Identify and mitigate project risks
• Maintain a detailed understanding of division, FDA and ISO regulation, clinical test
• Visit vendors for process improvement, investigation, or process establishment
• Work with project management to develop overall schedule
• Manage time and tasks within schedule
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements
• Maintains positive and cooperative communication and collaboration with all levels of employees, contractors and vendors
• Responsibilities will involve a thorough understanding of Bills of Materials (BOMs), design for manufacturability, process design, process validation, assembly techniques, and design evaluations
• Skilled in drafting protocols and reports related to the development of new processes and the optimization/validation of existing ones
• Skilled in interpreting manufacturing instructions and standard operating procedures, as well as reading, analyzing, and creating engineering diagrams
• Familiar with manufacturing techniques, including manufacturing of implants and small Ti parts
• Support the design, selection, and validation of new tools and equipment
• Evaluate production workflows and metrics, including yield, capacity, and capability
• Offer technical assistance to production and quality teams
• Skilled at solving problems using structured approaches and experienced in breaking down complex challenges into actionable steps
• Create and lead risk assessment activities, such as Process Failure Mode and Effects Analyses (PFMEAs)
• Provide technical support to vendors and suppliers on related issues
• Support cleanroom labeling machine challenges and scraps, including resolving issues with labeling machines, cameras, and PLC systems.
• Generate and submit VD Max Dose Audit and Environmental Monitoring quarterly reports for cleanroom, and any other biocompatibility and cleaning validation reports in support of cleanroom processes and audits.
• Review, provide feedback and approve Change Order documentation.
• Develop and generate engineering protocols/reports and submit Change Orders documentation.
• Participate in Material Review Board activities as needed, perform root cause investigation on NCMRs and help improve the NCMR trend. Respond to Discrepancy Reports for nonconforming products.