Development Engineer

About Company Ferris Mfg. Corp. is a privately owned medical device company known for its PolyMem® multifunctional wound care dressings, which cleanse, fill, absorb, and moisten wounds throughout the healing process. Since its founding in 1977, Ferris has focused on developing innovative, results-driven products that support effective healing outcomes. The company has received multiple industry awards recognizing its product design, technology, growth, and export performance. Ferris maintains a robust Quality System that meets or exceeds regulatory standards in the United States, Canada, the European Union, and other global markets.

Role Description The Development Engineer is a full-time, on-site role based at Ferris Mfg. Corp.’s headquarters in Fort Worth, TX. The Development Engineer plays an important role in supporting the development, qualification, validation, and ongoing control of the manufacturing processes, equipment, computerized systems, and quality systems used to manufacture Ferris medical devices. This position plans and executes validation and qualification activities, develops clear and technically sound documentation, analyzes results, and collaborates closely with Quality, Production, Engineering, R&D, Regulatory, and other teams.

As part of a small, collaborative medical device manufacturer, the Development Engineer will have the opportunity to contribute across a broad range of projects. In addition to validation and qualification activities, this role may support material qualifications, product and process changes, new product development, and other quality and engineering initiatives based on business needs. This is an opportunity to make a meaningful impact while gaining exposure to multiple areas of medical device development and manufacturing.

Qualifications

• Bachelor's degree in Engineering, Science, Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Manufacturing Engineering, or related technical discipline required; advanced degree desirable.
• 2+ years of engineering, validation, Quality, manufacturing, or related experience in the medical device, pharmaceutical, biotechnology, or other regulated industry preferred.
• Experience performing or supporting equipment and/or process validation strongly preferred.
• Experience developing and executing IQ/OQ/PQ documentation preferred.
• Medical device manufacturing experience preferred.

TECHNICAL/SOFTWARE SKILLS Desired experience includes:

• Equipment and process validation; IQ/OQ/PQ development and execution
• Validation protocols, reports, risk assessments, and technical documentation
• Statistical analysis and interpretation of validation data
• Microsoft Excel and other data-analysis tools
• Electronic Quality Management Systems (eQMS)
• Computerized System Validation (CSV) and/or Computer Software Assurance (CSA)
• Validation of manufacturing or laboratory equipment software
• Automated inspection or vision systems
• Electronic records and electronic signatures
• Basic database, programming, data manipulation, or automation skills are beneficial but not required
• CAD experience is beneficial but not required

DESIRED REGULATIONS AND STANDARDS EXPERIENCE

• FDA, QMSR, cGMP
• ISO 13485 MDSAP
• EU Medical Device Regulation: CE-Mark Approval, Technical Files
• ISO 14971 Risk Management
• ISO 10993 Biocompatibility
• 21 CFR, Part 820, Subpart C, Design Control

Ferris offers a competitive benefits package, including 401(k), medical, dental, and vision insurance, life insurance along with paid time off and paid holidays.