Quality Engineer View Details

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, draft and executes process/software validations. This position would be responsible to closely work with design & 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.

Duties And 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.
• Owns 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 PFMEA’s.
• 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 & principles of mechanical engineering.
• Maintain Work Instructions, BOM’s, preventative maintenance schedules, and Routers.
• Record test procedures and results; write test reports using numerical and graphical data using Excel and Word.
• Confer with engineering staff and submit reports of test results to 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.
• Perform other work-related duties as requested, directed or assigned by management.

Education and Experience

• BS in Mechanical, Manufacturing, or Biomedical Engineering required.
• MS in Mechanical or Biomedical Engineering preferred.
• Minimum of two years’ experience. Preferred is prior experience in medical device industry and familiarity with FDA CGMP regulations.
• Proficiency in 3D Modeling required.
• Proficiency in LabVIEW programming preferred.
• Experience in systems design.

This Position Is Responsible For The Design, Development, Verification, And Lifecycle Support Of Electronic Systems Used In Transonic’s Medical Devices And Life Science Instrumentation. As Part Of a Small And Highly Collaborative Engineering Team, This Role Will Support:

• New product development
• Sustaining engineering and obsolescence management
• Cost and manufacturability improvements
• Verification and validation activities aligned with medical device design controls

Engineers at Transonic gain broad exposure to the full development lifecycle — from user needs and design inputs through verification, regulatory documentation, production transfer, and post-market support.

Duties And Responsibilities

• 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
• Perform additional engineering tasks as assigned

Education And Experience

• 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

The Quality Engineer will support the quality, reliability, and compliance of Transonic’s ISO 13485 Quality Management System and medical device products. The primary focus of this position is leadership of the Company's Nonconforming Material Report (NCMR) process, including coordination of failure investigations, disposition of nonconforming materials, Engineering Change Order (ECO) scoping, quality standards and regulatory monitoring, and support of key Quality Assurance processes.

This position is responsible for ensuring nonconforming materials and products are properly documented, investigated, evaluated, dispositioned through the appropriate review process, and closed in a timely manner while supporting applicable Quality System and regulatory requirements. The Quality Engineer will work cross-functionally with Quality Assurance, Regulatory Affairs, Engineering, Manufacturing Engineering, Manufacturing, Planning, Repair, and other internal teams to support failure investigations, root cause analysis, ECO scoping, audit readiness, and continuous improvement initiatives.

Duties And Responsibilities NCMR Process Owner

• Serve as the primary Quality representative and process owner for the company’s 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 unresolved barriers.

• Assign and coordinate follow-up activities.

• Drive timely and effective closure.

• Work closely with Manufacturing, Engineering, Manufacturing Engineering, Planning, Repair, Quality Assurance, and other stakeholders to obtain the 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.

Quality Data, Trending, and Reporting

• 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.
• Communicate significant trends, risks, and recurring quality issues to Quality leadership and appropriate process owners.

Additional Quality System Support

• 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.

• Verification of completion and closure.

• Provide backup support for the deviation process, including documentation, routing, impact assessment, review follow-up, action tracking, and closure.

• Help ensure deviations are appropriately justified, reviewed, approved, implemented, and closed in accordance with Quality System requirements.

• 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.

• Provide additional Quality Assurance support as assigned by management.

Education And Experience

• 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.

As a member of the Stockroom Team; this individual is expected to have strong communication skills, attention to details, willingness to learn and suggest/ask for improvements/changes as needed. Along with the team the overall responsibility is to maintain on-time shipments (communication if there are issues), accurate inventory balances, and material availability to the shop floor based on proactive forecasts and discussions.

Duties And Responsibilities

• Receiving Materials

• Count Packages and Sign for materials

• Receive all material with PO's into computer system (currently Macola)

• Deliver direct material requiring inspection to the inspection area; deliver all other direct material to the stockroom. Packages addressed to a person or department should be delivered to the appropriate area.

• Shipping Products (Sales Revenue)

• Receive the Products from manufacturing physically and into inventory, review customer’s order for completeness, and accuracy, properly box and ship using the designated carriers

• Ship the product using vendor supplied software; freight, UPS, FedEx.

• Record the transaction in ERP system

• Create all export documentation necessary for export shipments

• Maintain a neat and orderly area

• Ability to 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 (RMA’s) (returned from the customer) 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.

Education and Experience

• High school diploma or its equivalent required.
• Previous related experience in stockroom and shipping/receiving is preferred.