Cross-Functional Integration: Partner with Engineering, Supply Chain, and Operations to ensure the smooth rollout of new equipment and process updates.
Continuous Improvement: Manage high-impact projects focused on yield enhancement, defect reduction, and throughput gains.
Data-Driven Insight: Use statistical modeling, simulation tools, and data analytics to inform strategic decision-making.
...
Serve as the escalation point for complex electro-mechanical equipment failures, performing root-cause analysis (NCR/CAPA) to implement permanent engineering solutions.
Identify opportunities for automation and equipment upgrades to support product scale-up, improve line capacity, and reduce labor costs.
Evaluate, modify, and manage the design of production tooling, jigs, and smart fixtures to ensure safe, repeatable, and ergonomic assembly operations.
...
Quality Assurance & Risk Management: Lead pFMEA (Process Failure Mode and Effects Analysis) sessions to mitigate risks. Design rigorous testing methodologies to confirm process capability and finished-product quality.
Documentation & Compliance: Establish and maintain comprehensive medical device history records (DHR), master validation plans, standard operating procedures (SOPs), work instructions, and checklists within safety and regulatory guidelines.
Financial & Capacity Analysis: Provide data-driven decision-making information by calculating production, labor, and material costs, reviewing line capacity, and estimating future resource requirements.
...
System Data Maintenance (SAP GTS): Monitor tracking systems for restricted parts and process synchronization routines (e.g., ZMATPUSH) to update ECCN classifications.
Logistics & Broker Coordination: Distribute approved documentation to clearance agents and freight forwarders (DSV, DHL, Morrison, CZE).
Record Keeping & Compliance Logs: Maintain compliance trackers for permit balances and archive shipping dossiers for audit visibility.
...
With the relevant technical competencies, lead and execute product realization from conceptual stages all the way thru manufacturing transition.
Able to support the development of technical proposals for customers, providing technical solutions to realize concepts and estimating associated labor and material costs required.
Recognized subject matter expert for one or more technical areas. See Technical Competencies section.
...
With the relevant technical competencies, lead and execute product realization from conceptual stages all the way thru manufacturing transition.
Able to support the development of technical proposals for customers, providing technical solutions to realize concepts and estimating associated labor and material costs required.
Recognized subject matter expert for one or more technical areas. See Technical Competencies section.
...
Strong participation in pricing/bid preparation and the development and management of contract terms.
Manages and monitors customer satisfaction day to day and formally (customer surveys, self-assessments, complaint management, problem resolution, satisfaction management).
Communicates frequently with customers to help ensure satisfaction with the company and the products.
...
In-depth working knowledge of VMWare/server virtualization environments, VMware hosts, clusters, vCenter, vSAN, NSX-T networking & security
Demonstrate deep technical experience including architecting, sizing, designing, installing, integrating, implementing, and supporting multiple varieties of Windows- based solutions,
Extensive Windows server experience, including RDS, DHCP server, etc.
...
Evaluates product specifications based on import /export regulations, classifies items and identifies any special instruction or requirements to employees and customers.
Ensures current and thorough knowledge of relevant regulations, laws and upcoming changes.
Oversees broker relationship as executed by junior staff, including performance, billings, and systems interface.
...