Sr. Manufacturing Engineer (Thousand Oaks, CA)

Envista Dentistry•Thousand Oaks, CA

8d•Onsite

About The Position

The Sr. Manufacturing Engineer provides technical leadership and engineering support 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, while sustaining and improving manufacturing operations, leading root-cause investigations, and driving continuous improvement in a regulated medical device environment. The position designs, establishes, validates, and improves manufacturing processes and equipment. Work includes supplier and vendor collaboration, process and equipment evaluations, engineering documentation, risk assessment, support for production and quality teams, and participation in audits and nonconformance activities. The engineer also supports cleanroom processes and reporting, manufacturing systems and procedures, and the company's strategic and quality initiatives. This position is required to work on-site full-time at the Thousand Oaks facility.

Requirements

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

Nice To Haves

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

Responsibilities

Lead cross-functional engineering projects to establish new product lines, including vendor sourcing and evaluation, procurement of required components, facility coordination, and SOP development for operator training.
Lead and execute CAPA, root-cause investigations, and process improvement efforts involving cleanroom, shop-floor, CNC, labeling, supply chain, and procurement operations.
Collaborate with molding vendors on mold-related improvement projects, including mold repair, design enhancements, and validation.
Improve CNC machining operations, including 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 improve operational efficiency.
Support SAP configuration and router creation, and develop standardized work instructions and procedures.
Facilitate and lead Kaizen events and continuous improvement initiatives across manufacturing functions.
Support audit activities, including BSI Micro, ISO, and regulatory audits, serving as a manufacturing-process subject matter expert.
Collaborate with Project Managers on engineering initiatives, contribute to unfamiliar scopes as needed, help develop project schedules, and manage tasks within schedule.
Support the company's strategic plan and management-identified initiatives, including those supporting the 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, and identify and mitigate project risks.
Visit vendors to support process improvement, investigations, or process establishment, and provide technical support to vendors and suppliers.
Develop and maintain understanding of applicable division, FDA, and ISO regulations and clinical testing requirements.
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, and 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, and provide technical assistance to production and quality teams.
Use structured problem-solving approaches to break complex challenges into actionable steps.
Create and lead risk assessment activities, including Process Failure Mode and Effects Analyses (PFMEAs).
Support cleanroom labeling-machine challenges and scrap issues, including resolving problems with labeling machines, cameras, and PLC systems.
Generate and submit VD Max Dose Audit and quarterly Environmental Monitoring reports for the cleanroom, as well as other biocompatibility and cleaning-validation reports supporting cleanroom processes and audits.
Review, provide feedback on, and approve Change Order documentation; develop engineering protocols and reports and submit Change Order documentation.
Participate in Material Review Board activities as needed, investigate 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.