Design Control Engineer

GEX is seeking a detail-oriented and process-driven individual to join our team at our corporate headquarters in Palm City, Florida. This position requires competence in design and development engineering within an ISO compliant quality management system, including defining functional requirements for products and services based on user requirements. The work is heavily weighted towards technical documentation including developing and controlling design plans for mature, legacy products and new products.

You will participate in design reviews with product managers, stakeholders and external providers as the team works to finalize and approve designs and move forward to verify and validate them as part of development or change. You will play a critical role in helping GEX ensure that our products meet customer requirements, quality standards, and regulatory expectations.

Essential Responsibilities

· Developing and reviewing technical documentation including requirements, specifications, verification and validation plans and protocols, product information documents, internal procedures and works instructions, and other relevant documented information.

· Performing documented risk assessments on designs.

· Remediation of legacy designs, bringing them up to current design planning documentation standards.

· Coordination with engineering colleagues and manager on prioritization and adjusting to business needs.

· Supporting continuous process improvement initiatives.

· Collaborate with cross-functional teams including Engineering, Quality, Manufacturing, and Customer Support.

· Working cross-functionally to identify process gaps, drive collaboration, and implement effective solutions.

· Maintaining traceability between product requirements, risk assessments, and verification activities.

· Assisting in identifying and resolving product and process compliance issues.

· Supporting audits and regulatory compliance efforts, as needed.

· Contributing to ongoing design planning process improvements.

Required Qualifications

· Bachelor’s degree in engineering or related technical discipline.

· Experience in design and development 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 a certified ISO quality management system environment such as ISO 9001, ISO 13485 or similar.

· Experience with requirements definition, traceability matrices, and related verification and validation.

· 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 regulated industries such as medical devices manufacturing, pharmaceuticals manufacturing and sterilization, or related fields.

· Background in process improvement initiatives and quality-focused engineering environments.

What Makes You Successful

· Highly organized and detail-oriented individual that is an excellent communicator.

· 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.

· Contribute to meaningful solutions for medical device sterilization and food safety.

· Enjoy working in beautiful Palm City, Florida, just minutes from Florida's Treasure Coast and Palm Beach region.

· Work in a small business environment with a team of dedicated people.

· Help deliver solutions to some of the world’s best medical device and pharmaceutical companies.

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.