Design Control Product Engineer

Job Description

GEX is seeking a detail-oriented and process-driven Design Control/Product Compliance Engineer to join our team at our corporate headquarters in Palm City, Florida. This position is ideal for an individual who enjoys technical documentation, process improvement, and ensuring product compliance with customer and regulatory requirements.

The role is approximately 70% focused on technical documentation and involves working with a mature product line to develop and maintain engineering documentation, perform risk assessments, and create verification test plans. This position will play a critical role in ensuring products meet customer expectations and quality standards.

Essential Responsibilities

• Develop, review, and maintain technical documentation, specifications, procedures, and engineering records.
• Perform product and system risk assessments and maintain associated documentation.
• Assist in detailed remediation of legacy designs, bringing them up to current engineering standards and expectations. Demonstrate agility in working across multiple departments to identify process gaps, drive collaboration, and implement effective solutions.
• Create, execute, and document verification and validation test plans and protocols.
• Ensure products comply with written requirements and applicable quality standards.
• Support continuous process improvement initiatives across engineering and quality functions.
• Collaborate with cross-functional teams including Engineering, Quality, Manufacturing, and Customer Support.
• Maintain traceability between product requirements, risk assessments, and verification activities.
• Assist in identifying and resolving product and process compliance issues.
• Support audits, quality system activities, and regulatory compliance efforts.
• Contribute to ongoing improvements in documentation practices and engineering processes.

Required Qualifications

• Bachelor’s degree in engineering or a related technical discipline.
• Experience in systems engineering, quality engineering, product compliance, or related field.
• Strong technical writing and documentation skills.
• Experience conducting risk assessments and developing verification test procedures.
• Knowledge of requirements management and product lifecycle processes.
• Experience working within an ISO 9001-certified environment and demonstrated expertise with ISO 9001 Quality Management Systems preferred.
• Strong analytical, organizational, and problem-solving skills.
• Excellent verbal and written communication skills.
• Proficiency with Microsoft Office and technical documentation tools.

Preferred Qualifications

• Experience in industries such as medical devices manufacturing, pharmaceuticals manufacturing, or other quality driven or regulated manufacturing applications.
• Familiarity with quality management systems, CAPA processes, and audit support activities.
• Experience with requirements, traceability and validation methodologies.
• Background in process improvement initiatives and quality-focused engineering environments.

What Makes You Successful

• Highly organized and detail oriented.
• Passionate about technical documentation and quality.
• Comfortable working with established products and improving existing processes.
• Strong collaborator who can work effectively across multiple departments.
• Committed to delivering accurate, compliant, and customer-focused engineering solutions.

Why Join GEX?

• Work for an established industry leader serving global customers.
• Be part of a collaborative and quality-focused team.
• Opportunity to contribute to meaningful applications including medical device sterilization and food safety.
• Enjoy working in beautiful Palm City, Florida, just minutes from Florida's Treasure Coast and Palm Beach region.

GEX is an Equal Opportunity Employer and values diversity in the workplace.

GEX is a leading provider of dosimetry products and services for the radiation processing industry. As a single-source supplier, GEX supports a wide range of gamma, electron beam (e-beam), and x-ray radiation processing applications, including medical device sterilization, surface decontamination, food irradiation, and the curing of inks and coatings.
Located in beautiful Palm City, Florida, just 40 minutes north of Palm Beach, GEX is committed to delivering innovative solutions and exceptional quality to customers around the world.

GEX is a leading provider of dosimetry products and services for the radiation processing industry. As a single-source…