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Product Development Engineer I
Job Description
TrackX Technology is looking to hire a full-time entry level product development engineer. The engineer will be trained in product development with a focus on the hardware aspect and the servicing of the company's product. Please include a cover letter and a copy of your resume when applying.
Responsibilities
- Manage and maintain servicing of existing hardware inventory.
- Perform Verification and Validation testing
- Write protocols and reports
- Development of design history file documentation
- Perform root cause investigations regarding hardware products
- Investigate Non-Conformance Reports (NCRs).
- Perform Receiving Inspection on R&D Components
- Support QC team as needed with hardware related activities
- Maintain cross-departmental communication
- Assist in the translation of user needs to design inputs
- Assist in new hardware development research
- Assist in complaints and CAPAs investigations
- Assist in development of Instructions for Use (IFU) and training materials
- Assist in development and refinement of technical designs and concepts
- Assist Sr Product Development Engineer in other duties as assigned
Qualifications
- Bachelor's or Master's degree in engineering
- 0-1 years of experience
- Strong organizational, analytical, and problem-solving skills
- Ability to adapt to changes in the work environment while managing tasks and competing project demands
- Ability to plan and prioritize workload
- Ability to work with biological specimens and cadavers
- Detail-Oriented
- Proficient with Microsoft Office
- Strong verbal and written communication skills
- Must be a US citizen or naturalized citizen
- Located in or willing to relocate to the RTP area (Raleigh Durham Triangle)
Preferred Qualifications
- Proficiency in reading and understanding various technical documents including engineering drawings, material specification sheets, etc.
- A basic understanding of quality assurance principles and regulatory requirements.
- Knowledge of FDA and ISO requirements related to medical devices and quality management systems.
- Knowledge or experience with 3D Printing (additive manufacturing) technologies and injection molding processes.
Submit Resume →
Quality Engineer I
Job Description
TrackX Technology is looking to hire a full-time entry level quality engineer. The engineer will assist in ensuring that TrackX products meet the standards of quality and regulatory compliance. You will work closely with cross-functional teams to support product development, testing, and continuous improvement efforts.
Responsibilities
- Responding to day-to-day design, production, and customer quality issues related to the TrackX product.
- Perform root cause analysis and corrective/preventive actions (CAPA) investigations for non-conformance, product issues, process errors, and design problems.
- Collaborate with engineering, manufacturing, suppliers, and regulatory teams to resolve quality-related issues.
- Participate in product testing, inspections, and audits to verify product quality and compliance with specifications.
- Review manufacturing instructions for completeness, and correctness.
- Ensure procedures and work instructions are accurately and appropriately documented.
- Assist with the creation, review, and monitoring of established quality inspection procedures and test plans for new and existing products.
- Review and approve deviation requests from suppliers.
- Conduct statistical analysis of production processes and reporting of findings.
- Collect, organize, monitor, and distribute information related to supplier quality and process improvement.
- Assist in the evaluation of potential new suppliers and audits of existing suppliers.
- Assist in service and repair activities.
- Ensuring initial incoming product quality through First Article Inspection (FAI) and receiving inspection.
- Assist your direct report(s) in other duties as assigned.
Requirements
- Located in or willing to relocate to the RTP area (Raleigh Durham Triangle).
- Bachelor's degree in engineering.
- 0-1 years of experience.
- Strong organizational, analytical, and problem-solving skills.
- Ability to adapt to changes in the work environment and manage tasks and competing project demands.
- Ability to plan and prioritize workload.
- Detail-oriented.
- Proficient with Microsoft Office.
- Strong verbal and written communication skills.
- Ability to effectively communicate technical concepts, problems, and ideas to various levels within the organization.
- Work collaboratively within and across cross-functional teams.
- Must be a US citizen or naturalized citizen.
Preferred Qualifications
- Proficiency in reading and understanding various technical documents including engineering drawings, material specification sheets, etc.
- A basic understanding of quality assurance principles and regulatory requirements.
- Knowledge of FDA and ISO requirements related to medical devices and quality management systems.
- Knowledge or experience with 3D Printing (additive manufacturing) technologies and injection molding processes.
Submit Resume →
Software Engineer [WPF/C#/.Net Framework]
Job Description
TrackX Technology, Inc. is seeking a full time Software Developer (WPF Desktop) in the RTP area. The successful candidate will work with our existing team on enhancements to FDA-approved medical-device standalone software along with a variety of support systems.
Responsibilities
- Work with local development and test team to enhance FDA-approved medical-device
- Enhance and develop support and diagnostic tools
- Automate test and verification processes
Requirements
- 4+ years of experience with Microsoft .Net C#/WPF desktop application development
- Visual Studio 2019, Git and Azure Devops
- .Net Core on Windows
- Windows 10 embedded device deployment
Submit Resume →