Sr. Manufacturing Engineer (Thousand Oaks, CA)

Envista Holdings Corporation•Los Angeles, CA

9d•$117,000 - $143,000•Onsite

About The Position

The Sr. Manufacturing Engineer provides technical leadership and performs engineering activities to ensure medical device projects meet applicable regulatory requirements and quality standards. The role leads complex cross-functional projects, including establishing new process and operation lines, retrofitting equipment, and supporting audits and regulatory submissions. It serves as a technical lead for Quality, Manufacturing, EHS, Procurement, Facilities, and Project Management teams. The engineer sustains and improves manufacturing operations, leads root cause investigations, and advances continuous improvement initiatives. The position involves designing and establishing processes, evaluating designs and production performance, managing project risks and schedules, supporting vendors and suppliers, and contributing to quality management and regulatory compliance. The role also develops and reviews engineering documentation, supports audits and nonconformance investigations, and provides technical assistance to production and quality teams. The position is based full-time on-site at the Thousand Oaks facility.

Requirements

Bachelor’s degree in Mechanical Engineering or a related engineering field.
At least 7 years of experience in manufacturing engineering.
At least 3 years of experience with SolidWorks.
Experience implementing and sustaining production processes, including overseeing processes performed at subcontractors.
Ability to work full-time on-site at the Thousand Oaks facility.
Experience leading teams or projects involving cross-functional roles.
Required knowledge of CNC manufacturing methodologies and machining methods.
Ability to fully interpret engineering drawings or blueprints.
Experience with Microsoft Word, Excel, and Outlook.
Good communication skills.

Nice To Haves

Medical device experience is preferred.
Experience with lean methodologies, including single-piece flow, SMED, 5S, visual management, Gemba walks, and quality at the source.
Experience with Swiss machines is a plus.
Injection molding experience is highly desired.
Familiarity with titanium machining is a plus.
Experience with statistical or Six Sigma tools such as gage R&R, hypothesis testing, Pareto charts, cause-and-effect diagrams, and FMEA.
Ability to implement AI to maximize productivity and efficiency.

Responsibilities

Lead cross-functional engineering projects to establish new product lines, including vendor sourcing and evaluation, component procurement, facility coordination, and SOP development for operator training.
Lead and execute CAPA, root cause investigations, and process improvements involving cleanroom, shop floor, CNC, labeling, supply chain, and procurement operations.
Lead mold-related improvement projects with molding vendors, including mold repair, design enhancements, and validation.
Collaborate with CNC operations on machining improvements, cycle-time reduction, SMED events, setup-time reduction, and process improvement.
Develop and implement manual fixtures, assembly methods, and equipment improvements for manufacturing and labeling processes.
Retrofit and innovate equipment, including labeling and capping machines, to support operational efficiency.
Support SAP configuration, router creation, and standardized work instructions and procedures.
Facilitate and lead Kaizen events and continuous improvement initiatives across manufacturing functions.
Assist with audits, including BSI Micro, ISO, and regulatory audits, as a subject matter expert in manufacturing processes.
Collaborate with Project Managers on engineering initiatives and contribute to unfamiliar scopes as needed.
Support the company’s strategic plan and other initiatives identified by management in support of QMS and regulatory requirements.
Design new processes and improve and maintain existing processes; establish process requirements and specifications.
Use experimental and numerical analysis to evaluate designs, NCMRs, and other issues; identify and mitigate project risks.
Maintain understanding of division, FDA, and ISO regulations and clinical testing requirements.
Visit vendors for process improvement, investigations, or process establishment; provide technical support to vendors and suppliers.
Work with project management to develop schedules and manage time and tasks within them.
Apply knowledge of BOMs, design for manufacturability, process design and validation, assembly techniques, and design evaluations.
Draft protocols and reports for new process development and optimization or validation of existing processes.
Interpret manufacturing instructions and SOPs; read, analyze, and create engineering diagrams.
Support the design, selection, and validation of new tools and equipment.
Evaluate production workflows and metrics, including yield, capacity, and capability.
Provide technical assistance to production and quality teams and solve complex problems using structured approaches.
Create and lead risk assessment activities, including Process Failure Mode and Effects Analyses (PFMEAs).
Support cleanroom labeling machine issues and scrap, including troubleshooting labeling machines, cameras, and PLC systems.
Generate and submit VD Max Dose Audit and quarterly Environmental Monitoring reports for cleanroom processes, as well as other biocompatibility and cleaning validation reports supporting cleanroom processes and audits.
Review, provide feedback on, and approve Change Order documentation; develop and generate engineering protocols and reports and submit Change Order documentation.
Participate in Material Review Board activities as needed, investigate root causes of NCMRs, help improve NCMR trends, and respond to Discrepancy Reports for nonconforming products.
Maintain positive and cooperative communication and collaboration with employees, contractors, and vendors at all levels.