RailPros was founded in 2000 and is exclusively focused on providing rail and transit engineering and construction services.  The firm is headquartered in Irving, Texas. We employ more than 1000 rail and transit engineers, construction, inspection, design, and field support staff. Through our extensive resources, we are able to respond to the full spectrum of the industry’s management, construction, planning, and design needs. 

RailPros’ senior staff includes top industry talent who bring diverse and comprehensive expertise to the RailPros team.  Our senior management team includes licensed professional engineers; several railroad professionals with more than 20 years of industry experience each; and former employees of BNSF, UP, Amtrak, Caltrans, and SCRRA. Having worked closely with Class I carriers and commuter rail agencies to implement, upgrade, and expand their rail services, RailPros senior staff members offer clients time-tested railroad and project experience in managing, designing, and constructing projects under live railroad traffic, with minimal disruption to existing rail service.
 
Through extensive experience providing project management, construction management, project development, project design, operational support and railroad coordination for our clients, RailPros has a unique understanding of the rail and transit needs of the industry.

Industry: Business Consulting and Services
Company Size: 1,001-5,000 employees

RailPros

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**Job Summary**

The Rail Systems Engineer I performs entry-level engineering work supporting the design, development, integration, and testing of railroad signaling and communications systems. This role works under the supervision of senior engineers and project managers to assist in technical tasks related to rail signal equipment, wayside systems, grade crossings, and communications infrastructure.

The Rail Systems Engineer I applies foundational engineering knowledge to support system documentation, testing activities, and integration tasks while gaining experience with railroad standards, safety practices, and industry regulations.

**Qualifications**

**Essential Duties & Responsibilities**

- Assist in the design and development of railroad signaling and communications systems.

- Support preparation of engineering drawings, wiring diagrams, equipment layouts, and technical documentation.

- Assist with system integration activities for signal houses, signal control systems, and communications networks.

- Assist in preparation of test procedures, test reports, and commissioning documentation.

- Review technical specifications and assist in verifying compliance with project requirements.

- Coordinate with engineering, manufacturing, and field teams to support project delivery.

- Maintain organized records of engineering documents and revisions.

- Support preparation of technical reports and presentations.

- Participate in project meetings and document technical discussions and action items.

- Learn applicable railroad standards, safety practices, and regulatory requirements.

- Demonstrate willingness to learn railroad signal systems and integration practices.

- Other duties as assigned or required to meet business needs.

**Knowledge, Skills, & Abilities**

- Proficient in Microsoft Programs (Outlook, Excel, Word), as well as Adobe PDF Suite.

- Ability to create and revise MicroStation and AutoCAD drawings, as required.

- Ability to review drawings for quality, accuracy, and compliance with client specifications.

- Capable of creating material lists based on drawings.

- Ability to create engineering distributions/submittals to clients.

- Possesses effective verbal and written communication skills

- Excellent problem-solving skills

- Ability to work independently and as part of a team.

**Required Education And Experience**

- High School Diploma/GED

- Technical training with AutoCAD and/or MicroStation.

- Basic understanding of electrical circuitry.

- Proficiency in digital technology including use of tablet and/or laptop computer

**Preferred Education And Experience**

- Associate or Bachelor degree in Engineering, Electronics, Programming, or related field.

- 1 years’ experience with AutoCAD and/or MicroStation.

**Additional Qualifications, Certifications, Etc.**

- Valid driver’s license required.

- OSHA 10 Construction Certification is a plus.

**Travel**

- This position may require travel. On occasion, travel to RailPros headquarters, field offices or client offices, work sites, and other project related locations may be required.

Rail Systems Engineer I

SMC Ltd. offers global solutions, contract manufacturing and molding services for the medical device, diagnostics, and pharmaceutical industries. Services include design, engineering, thermoplastic molding including insert, two-shot and micro, liquid silicone injection molding (LIM) and complete device assembly. Project integration, supply chain management, validation, packaging and labeling, and sterilization responsibility are systematically controlled. Facilities offer ISO 13485, quality systems, white room, class 7 and 8 clean rooms.

SMC Group:

Oval Medical Technologies, an SMC Ltd. company, is a medical device company developing in revolutionary autoinjector platforms. Oval’s unique approach allows for devices that are smaller, easier and safer to use than any other device currently available. Pharmaceutical partners can utilise Oval’s technology to deliver viscous formulations and sensitive biological drugs that would otherwise not be possible to deliver in current marketed injectable devices. Oval is able to tailor the technology for specific patient populations producing devices that are truly patient centric. www.ovalmedical.com

Industry: Medical Device
Company Size: 501-1,000 employees

SMC Ltd

About Us:

SMC Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.

**About The Role**

We are seeking a highly skilled Quality Engineer with experience in Medical Device, Combination Products or Assembly‑Label‑Pack (ALP) manufacturing. In this role, you will ensure the highest level of product quality, regulatory compliance, and operational excellence across the manufacturing lifecycle. You will be a key contributor to sustaining engineering, continuous improvement, risk management, and quality systems execution.

This Quality Engineering role is responsible for the following:

- Provide Quality Engineering support for combination products, ALP manufacturing lines, and medical device operations.

- Ensure compliance with FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and applicable global regulatory requirements.

- Support validation activities including IQ/OQ/PQ, process validation, equipment qualification, and test method validation.

- Participate in or lead risk management activities per ISO 14971, including DFMEA, PFMEA, hazard analyses, and control strategy development.

- Own and maintain Quality System documentation including work instructions, specifications, and control plans.

- Lead or support investigations for nonconformances, deviations, and customer complaints through root cause analysis using tools such as 5 Whys, Fishbone, Fault Tree Analysis, or DOE.

- Develop and implement effective Corrective and Preventive Actions (CAPA); verify and validate effectiveness.

- Monitor manufacturing risks and develop mitigation strategies focused on patient safety and product quality.

**Qualifications Required**

- 5+ years of experience in medical device combination product quality engineering or ALP manufacturing, assembly operations, or packaging/labeling processes.

- Experience with sterile barrier packaging, labeling control systems, or drug‑device interface considerations.

- Working knowledge of ISO 13485, ISO 14971, FDA QSR, and applicable combination product regulations.

What SMC has to offer?

- Clean, Climate-Controlled Environment

- Stable schedule

- Paid holiday and PTO

- Health, dental, and vision insurance

- 401(k) retirement savings

- Life and disability insurance

- Promotional opportunities

- Training and career growth programs

- Amazing co-workers

- Tuition reimbursement

- Employee Assistance Program

At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job.  If your experience is close to what you see listed here, please still consider applying.  We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions.  Please let us know if you require reasonable accommodations during the interview process.

SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify.

Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

#IND

Quality Engineer – Medical Device Combination Products / ALP Mfg

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