JOValidation Engineer – Medical Device Manufacturing
BS-level Process Engineering roles on Crosslinked list a median of $113k (699 that show pay).
Validate and optimize medical device manufacturing processes including polymer extrusion of medical tubing, running IQ/OQ/PQ and DOE.
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Worth knowing
Why it is interesting. Hands-on polymer extrusion validation for medical tubing, from NPD through commercial production
Might not be for you. Validation documentation-heavy and staffing-agency contract; extrusion is only one part of the scope
Adjacent materials roleSupports extrusion process development and optimization for medical tubing; bachelor's in Materials or Polymer Engineering; preferred polymer extrusion experience
- Seniority
- Entry level
- Work
- On-site
- Type
- Contract
- Degree
- BS
- Industry
- Medical devices
- Role
- Process Engineering
- Schedule
- Standard
Role details
Validation Engineer Medical Device Manufacturing
Pay Rate: $28.00 per hour
Schedule: Monday Friday | 8:00 AM 5:00 PM
Work Location: On-site - Añasco
Job Type: Full-Time
Job Summary
We are seeking a motivated and detail-oriented Validation Engineer to support New Product Introduction (NPI), New Product Development (NPD), and process validation activities within a medical device manufacturing environment.
The ideal candidate will have a background in engineering, strong analytical and problem-solving skills, and experience working in a regulated manufacturing environment.
This position will focus on supporting process development, validation, and optimization of medical device components while ensuring compliance with FDA, ISO, and internal quality standards.
Key Responsibilities
Support the development, validation, and optimization of manufacturing processes for medical device components.
Execute and document process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Support New Product Introduction (NPI) and New Product Development (NPD) projects from initial development through commercial production.
Assist with Design of Experiments (DOE), process testing, and statistical data analysis to improve product quality and manufacturing performance.
Collaborate with Engineering, Quality, Manufacturing, Regulatory, and RD teams to meet project objectives.
Develop and maintain validation protocols, technical reports, standard operating procedures (SOPs), and work instructions.
Analyze manufacturing data, identify process improvements, and support troubleshooting activities.
Participate in equipment qualification, installation, and manufacturing trials.
Support extrusion process development and optimization for medical tubing and components.
Ensure compliance with FDA regulations, ISO standards, and company quality and safety procedures.
Prepare technical documentation and present findings related to process validation and product development.
Identify opportunities to improve manufacturing efficiency, process capability, and product quality.
Qualifications
Required
Bachelors degree in Mechanical, Chemical, Materials, Polymer, or a related Engineering discipline.
Engineering experience in manufacturing, process development, validation, or a related technical field.
Knowledge of process validation principles, manufacturing processes, and technical documentation.
Strong analytical, organizational, and problem-solving skills.
Ability to interpret technical data and prepare detailed reports.
Proficiency in Microsoft Office applications, particularly Excel.
Strong written and verbal communication skills.
Ability to work independently and collaborate with cross-functional teams.
Comfortable working in manufacturing and cleanroom environments.
Preferred
23 years of engineering experience in a regulated manufacturing environment.
Experience in medical device manufacturing.
Hands-on experience executing IQ/OQ/PQ validations.
Experience with polymer extrusion processes, particularly medical tubing.
Knowledge of FDA regulations, ISO 13485, and quality management systems.
Experience with Design of Experiments (DOE), statistical analysis, and process capability studies.
Previous involvement in NPI/NPD projects.
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