NPI - NPD/R&D ENGINEER I

Job Overview

Process Development Engineer I with extensive experience in the optimization, implementation, and standardization of industrial processes in manual, semi-automatic, and automatic environments. Specialized in the detailed analysis of production processes to improve efficiency, quality, and operational safety. Expert in the design and adjustment of tools and equipment, as well as in technical documentation and training of work teams. Demonstrated ability to lead continuous improvement projects and support the transfer of processes from development to mass production, working collaboratively with engineering, quality, and manufacturing departments.

Job Requirements

• Bachelor's degree in Engineering, Plastics, Chemical, Biomedical or Mechanical Engineering preferred
• 2+ years of engineering experience
• 1+ years of working experience in the Medical Device Industry
• 1+ years of working experience in new production development or product transfers
• Understanding of Quality Management Systems (QMS) requirements that involve: Process Mapping, Manufacturing Process Instructions, DOE, Engineering studies and Process Characterization, OQ/PQ Protocol and Reports 
  IQ/OQ Protocols and Reports, PFMEAs, MVP/MVRs, Sadistic Process Controls (SPC), Basic knowledge in different manufacturing technologies not limited to laser, braiding, extrusions, polymer lamination, polymer bonding, adhesive application and curing, injection molding, test equipment, balloon forming, ultrasonic bonding, annealing process, 3D printing, basic Knowledge in the structured analysis of technical requirements for the design of tools, fixtures, and manufacturing equipment. Ability to identify problems in existing or developing processes, interpret technical data, and develop practical solutions that improve efficiency, safety, and quality.
• Collaboration: Effective teamwork and clear communication with senior engineers, technicians, and production.
• Learning Ability: Ability to absorb technical and regulatory knowledge.
• Critical Thinking: Identifying deviations and formulating improvement proposals with data support.
• Time Management: Ability to handle multiple tasks under supervision.
• Adaptability: Ability to adjust to project changes or priorities.
• Attention to Detail: Accurate testing, technical documentation, and regulatory compliance.

What your background should look like

Key Responsibilities

New Process Development

• Active participation in the development and implementation of manual and semi-automated manufacturing processes for medical devices, with a focus on operational efficiency and regulatory compliance (ISO 13485, FDA 21 CFR Part 820). Support in the design and validation of workstations, fixtures, hand tools, and test equipment. Experience in technical documentation (MPI, WI) and process data collection for technical analysis and continuous improvement. Collaboration with multidisciplinary teams to adapt processes to production and design requirements, promoting practical, safe, and quality-oriented solutions.

New Product Introductions

• Experience in managing and supporting New Product Introduction (NPI) projects, focused on ensuring an efficient and successful transition from development to production. Ability to collaborate in the evaluation, design, and validation of manual and semi-automated manufacturing processes, ensuring safe conditions, resource optimization, and compliance with quality standards. Ability to document and standardize production procedures and identify opportunities for continuous improvement during the transfer and scale-up of new products. Strong focus on collaborative work with multidisciplinary teams, including engineering, quality, and production, to ensure that implemented processes are robust, repeatable, and aligned with business objectives.

Problem Solving

• Proactive approach to solving technical and operational problems within industrial processes. Experience in identifying and analyzing root causes using basic diagnostic tools, supporting the implementation of effective solutions that contribute to resource optimization, downtime reduction, and continuous improvement. Ability to work as a team with different areas, collaborating in the generation of corrective and preventive actions that ensure the quality and efficiency of production processes. Oriented toward constant learning and the practical application of structured methodologies to solve complex challenges in dynamic environments.

Quality, Safety and Regulatory Compliance (Supporting)

• Work with Quality Team to ensure all manufacturing processes and equipment comply with FDA regulations, ISO standards, and other relevant industry guidelines
  Comply with safety and security procedures and report potentially unsafe conditions when using equipment and materials properly.

Preferred Skills & Experience

• Hands-on experience with complex steerable or multi-lumen catheter assembly development and manufacturing with that includes manufacturing technologies with mandrel design, PTFE assembly, reflow, braiding, tipping and extrusion 
• Basic knowledge with design controls, FDA regulation, GMP practices, and QSR requirements
• MS Office proficiency  
• Ability to achieve goals with effective planning and prioritization skills to meet immediate and long-range needs with independence
• Must be well-organized, detail-oriented, with excellent oral and written communication skills

Competencies