Process Development Engineer Staff

Job Description:

Fully competent engineer in all conventional aspects of process development, technology transfer, manufacturing engineering, and new product introduction activities. Responsible for leading product transfers, process development, process optimization, validation activities, and technical project execution from concept through commercial manufacturing.

This role serves as the technical lead and Subject Matter Expert (SME) for assigned products and manufacturing processes. The Process Development Engineer, Staff is responsible for coordinating cross-functional activities with Operations, Quality, Program Management, Manufacturing Engineering, and customers to successfully transfer, develop, validate, and launch new products while ensuring quality, cost, and timeline objectives are achieved.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Lead product transfers from sister sites and support successful implementation into Costa Rica manufacturing operations.

• Lead new product introduction (NPI/NPD) activities from development through commercialization.

• Act as the primary technical owner and Subject Matter Expert (SME) for assigned products and manufacturing processes.

• Plan, coordinate, and execute engineering activities, studies, experiments, and development programs supporting product launches and process transfers.

• Develop, optimize, and validate manufacturing processes to improve product quality, manufacturability, and operational efficiency.

• Lead technical investigations and problem-solving activities using Root Cause Analysis (RCA) methodologies.

• Design, execute, analyze, and document engineering studies and experimental activities.

• Support and lead validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation activities.

• Coordinate manufacturing trials, engineering runs, process qualifications, and validation efforts.

• Analyze technical data, statistical results, and experimental findings to support engineering decisions.

• Develop specifications, engineering documentation, and technical requirements associated with products and processes.

• Create, update, and maintain Work Instructions, Process Documentation, Inspection Plans, Validation Documentation, and Technical Reports.

• Partner closely with Quality Engineering to ensure compliance and successful implementation of process controls.

• Lead technical discussions and presentations with customers regarding product and process performance.

• Support Program Managers by identifying and mitigating technical risks impacting project execution.

• Coordinate training activities for operators and manufacturing personnel during process implementation and transfer activities.

• Evaluate and recommend equipment, fixtures, tooling, and process improvements.

• Perform manufacturing reviews and pre-validation assessments to ensure successful implementation of new processes.

• Properly document activities in accordance with engineering best practices, company procedures, and regulatory requirements.

• Write technical reports and engineering documentation with minimal supervision.

• Conduct experiments, record test procedures, collect data, analyze results, and document findings.

• Set up, adjust, and operate laboratory, manufacturing, and development equipment.

• Practice company safety, quality policies, and procedures while actively promoting compliance.

EDUCATION AND/OR EXPERIENCE

• Bachelor’s Degree in Engineering, Materials Engineering, Biomedical Engineering, Chemical Engineering, Industrial Engineering, or other related Engineering disciplines.

• Minimum 3-5 years of related engineering experience.

• English proficiency required at a B2 or C1 level is required to lead technical discussions, present engineering information, participate in customer meetings, and collaborate with sister sites and global teams.

• Lean Six Sigma Green Belt, Lean Six Sigma Black Belt, SolidWorks Certification or Technical Drawing Certification is a plus.

• Medical Device industry experience is preferred

• Experience in Process Development, Product Transfer activities, New Product Introduction (NPI/NPD), Process Validation, including IQ, OQ, and PQ execution and documentation, Root Cause Analysis investigations, and Statistical analysis and engineering studies.

OTHER SKILLS AND ABILITIES

• Strong project leadership capabilities.

• Strong technical problem-solving skills.

• Experience performing Root Cause Analysis (RCA).

• Experience supporting New Product Introduction (NPI) programs.

• Experience developing and executing validation protocols.

• Understanding of IQ, OQ, PQ, and Process Validation methodologies.

• Strong technical writing capabilities.

• Ability to define process specifications and technical requirements.

• Strong analytical and statistical evaluation skills.

• Ability to manage multiple priorities and projects simultaneously.

• Ability to work independently and lead cross-functional teams.

• Experience interacting directly with customers and presenting technical information.

• Adaptability and ability to work in dynamic development environments.

• Ability to work effectively under pressure and manage aggressive project timelines.

COMMENTS

This position description is an outline of the major recurring responsibilities of the job and is not intended to be all-inclusive. The incumbent(s) will typically perform other related job objectives, special assignments, and less significant responsibilities.

Success in this role requires strong technical leadership, hands-on process development experience, product transfer expertise, validation knowledge (IQ/OQ/PQ), customer-facing communication skills, and the ability to independently lead engineering projects from concept through successful manufacturing implementation. The ideal candidate will come from a Medical Device environment and have demonstrated experience launching new products, executing validations, supporting manufacturing scale-up activities, and leading technical problem-solving initiatives.