Shipping/Receiving Technician View Details

About the Role

Exercises technical leadership and analytical skills in the resolution of production issues. Demonstrates creativity in implementing process improvements and new manufacturing methods including the conception, design, and implementation of new tools, fixtures, and software. Prepares technical reports, drafts, and executes process/software validations.

This position is responsible for closely collaborating with design and mechanical engineers to provide necessary support by applying theory and principles of mechanical engineering to develop, assemble, modify, test, and/or calibrate prototype products, machinery, and test equipment under the direction of Manufacturing Engineering management staff.

As part of a small and highly collaborative engineering team, this role supports new product development, sustaining engineering, obsolescence management, cost and manufacturability improvements, and verification and validation activities aligned with medical device design controls. Engineers gain broad exposure to the full development lifecycle—from user needs and design inputs through verification, regulatory documentation, production transfer, and post-market support.

Responsibilities

• Review prototype, test instructions, and schematics to ascertain test specifications, procedures, and objectives.
• Interpret engineering prototypes, test instructions, and schematics to identify, modify, and plan requirements for fabrication, assembly, testing, and test nature of technical problems.
• Actively participate on new product release teams from the earliest phases to assure that design for manufacturing concepts are employed and to facilitate a smooth transition from Engineering to Manufacturing.
• Own the development of assembly processes for new products as well as the introduction of new methods into the assembly processes of current products and associated PFMEAs.
• Devise, fabricate, and assemble new or modified assembly and test fixtures using appropriate machine shop and/or hand tools or software modules.
• Apply DOE and statistical tools to identify root cause(s) of yield loss and propose and implement corrective actions; make recommendations for changes in test fixtures or test methods by applying theory and principles of mechanical engineering.
• Maintain Work Instructions, BOMs, preventative maintenance schedules, and Routers.
• Record test procedures and results; write test reports using numerical and graphical data in Excel and Word.
• Confer with engineering staff and submit reports of test results to the engineering department and recommend design or material changes.
• Actively participate in discussions related to changes in design, method of manufacture and assembly, and drafting techniques and procedures with staff and coordinate corrections.
• Document software specifications for review prior to development of software.
• Develop and release software in a controlled manner; ensure developmental software is not active prior to validation and release.
• Identify and resolve manufacturing errors expeditiously with attention to impact on safety/ergonomics, quality, cost, and production schedules from software.
• Design and develop analog, RF, and digital circuits for medical devices.
• Design and review analog and digital PCB layouts.
• Troubleshoot analog and RF circuits to the component level.
• Develop test methods and verification protocols for electronic PCB assemblies.
• Perform verification testing to confirm design performance and compliance.
• Evaluate and improve existing PCB assemblies for reliability, cost, and manufacturability.
• Support component selection, supplier changes, and obsolescence mitigation.
• Create and maintain design documentation, drawings, specifications, and ECOs.
• Support root cause investigations and corrective actions as needed.
• Collaborate cross-functionally to support regulatory submissions and audits.
• Serve as the primary Quality representative and process owner for the company’s Nonconforming Material Report (NCMR) program.
• Provide guidance on Quality System requirements, investigation expectations, risk evaluation, disposition decisions, documentation, and timely closure.
• Lead and coordinate cross-functional failure investigations involving nonconforming materials, components, assemblies, and finished products.
• Ensure nonconforming materials are appropriately identified, contained, evaluated, dispositioned, and documented.
• Facilitate daily cross-functional NCMR review meetings to prioritize newly opened NCMRs, review investigation and disposition status, address overdue actions, and assign follow-up activities.
• Drive timely and effective closure of NCMRs.
• Work closely with Manufacturing, Engineering, Manufacturing Engineering, Planning, Repair, Quality Assurance, and other stakeholders to obtain information needed to support investigation and disposition decisions.
• Ensure NCMR records are complete, accurate, appropriately approved, and maintained in accordance with applicable Quality System and regulatory requirements.
• Support root cause analysis and ensure investigation conclusions are supported by appropriate evidence and documented rationale.
• Analyze NCMR, failure investigation, deviation, and related quality data to identify trends, recurring issues, and emerging risks.
• Recommend opportunities for corrective action, preventive action, process improvement, supplier follow-up, or CAPA initiation.
• Develop and maintain meaningful NCMR metrics and key performance indicators.
• Prepare and present Management Review information related to NCMRs, failure investigations, deviations, ECO activities, and other assigned Quality System processes.
• Support the monitoring and review of applicable standards and regulatory requirements, including ISO 13485, FDA requirements, EU MDR, MDSAP, and other applicable Quality System expectations.
• Communicate relevant standards or regulatory updates to Quality, Regulatory Affairs, Engineering, Manufacturing, and leadership teams.
• Assist in evaluating the potential impact of new or revised standards and regulatory expectations on Quality System procedures, records, processes, and product-related activities.
• Provide backup support for ECO activities, including technical and quality review, ECO scoping, documentation follow-up, implementation task tracking, and verification of completion and closure.
• Provide backup support for the deviation process, including documentation, routing, impact assessment, review follow-up, action tracking, and closure.
• Support the company’s Safety Data Sheet program, including maintaining applicable records within the Quality Management System.
• Support CAPA activities associated with NCMRs, including investigation, root cause analysis, implementation of corrective actions, and effectiveness verification.
• Participate in internal and external audits by supporting audit preparation, record review, auditor requests, audit responses, and follow-up activities.
• Support minor internal audits, including audit planning, execution, documentation of results, identification of observations or opportunities for improvement, and corrective action follow-up.
• Identify Quality System gaps and support continuous improvement initiatives that strengthen compliance, documentation, process effectiveness, and operational performance.
• Receive materials: count packages, sign for materials, and receive all material with POs into the computer system (currently Macola).
• Deliver direct material requiring inspection to the inspection area; deliver all other direct material to the stockroom.
• Deliver packages addressed to a person or department to the appropriate area.
• Shipping Products (Sales Revenue): receive products from manufacturing physically and into inventory, review customer’s order for completeness and accuracy, properly box and ship using designated carriers.
• Ship the product using vendor-supplied software (freight, UPS, FedEx) and record the transaction in the ERP system.
• Create all export documentation necessary for export shipments.
• Maintain a neat and orderly area and work effectively and efficiently with great attention to detail.
• Review daily reports for shipping requirements and communicate as necessary.
• Maintain the Liability and Warranty Module for Shipping/Receiving Equipment.
• Process Repairs (RMAs) within the same business day.
• Maintain safe handling practices when handling any and all products and equipment.
• Perform cycle counts and maintain inventory accuracy.
• Perform other work-related duties as requested, directed, or assigned by management.

Requirements

• BS in Mechanical, Manufacturing, or Biomedical Engineering required; MS in Mechanical or Biomedical Engineering preferred.
• Minimum of two years’ experience; prior experience in the medical device industry and familiarity with FDA CGMP regulations preferred.
• Proficiency in 3D Modeling required; proficiency in LabVIEW programming preferred.
• Experience in systems design.
• Bachelor’s Degree in Electrical Engineering or a related field required; 2-3 years’ experience preferred.
• Experience with programs for schematic capture, PC board layout, CAD, and database programs.
• Experience with microcontroller programming and FPGA programming is a plus.
• Experience in regulated industries (medical device preferred) is a plus.
• Bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical field required.
• 3+ years of experience in quality engineering, quality assurance, nonconforming material review, or regulated manufacturing preferred.
• Prior experience in a regulated environment, preferably medical device, ISO 13485, FDA, MDR, MDSAP, or similar regulated industry, is preferred.
• Strong communication skills, attention to detail, and willingness to learn and suggest improvements.