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Manage medical device projects from scoping to execution, focusing on budgeting, risk management, and stakeholder communication. Lead teams through a product development process and ensure strong customer relationships.

The Senior Staff Process Development Engineer oversees manufacturing line design, capacity analysis, and process validation while leading cross-site initiatives and mentoring junior engineers.

The role involves developing textile-based medical structures, leading technical projects, and collaborating with teams for process improvement and validation. Hands-on work is required along with writing SOPs and managing multiple projects.

Leads the sales organization and commercial strategy for a medical-device manufacturing portfolio. Owns revenue growth, profitability, pipeline development, forecasting, strategic accounts, negotiations, market expansion, and sales performance. Develops Sales Directors and builds high-performing teams while partnering cross-functionally with executive, engineering, operations, quality, finance, legal, and marketing leaders. Represents the company with strategic customers and industry stakeholders and travels approximately 50% of the time.

The Staff Quality Engineer ensures compliance to standards in medical device projects, supporting product development and manufacturing through quality assurance practices, statistical analysis, and risk management.

Develop and validate laser-based manufacturing processes from prototype to production. Run and troubleshoot lasers, translate drawings into laser programs using CAD, perform statistical analysis (DOE, CPK/PPK, ANOVA), create quality documentation, provide production support, and follow safety and maintenance protocols in a medical device environment.

The Senior Staff Process Development Engineer designs and implements manufacturing automation solutions for catheter production, focusing on error-proof processes and scalability.

Provide hands-on manufacturing engineering support for Nitinol melting, casting, and downstream processing. Troubleshoot equipment and process issues, maintain documentation, lead Lean/Six Sigma continuous improvement, support new product/process introductions and scale-up, execute IQ/OQ/PQ validations, and ensure FDA/ISO 13485 quality and compliance while partnering cross-functionally.

Manage day-to-day facility and office operations for the Laguna Niguel site, including vendor and landlord relationships, supplies and procurement, onboarding support, facilities maintenance and calibration tracking, basic IT and office moves, customer order processing, and reporting site metrics to senior management. Acts as first point of contact and backup for Customer Solutions, improving processes and ensuring invoices and payments are handled timely.