Process Development Engineer, Staff

Job Description:

Confluent Medical Technologies is a financially healthy and rapidly growing medical device company dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components and tubing, balloon expandable stents and catheters, complex catheters, biomedical textiles, and high precision polymer tubing. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.

We are looking for a Process Development Engineer Staff join our team in Costa Rica.

ESSENTIAL DUTIES AND RESPONSABILITIES include the following. Other duties may be assigned.

• Serve as a fully competent engineer, independently handling most assignments with minimal direction.
• Lead process development from proof-of-concept and prototyping through manufacturing validation and sustained production.
• Plan, coordinate, and execute engineering studies, tests, and programs supporting existing production and new product development.
• Develop, implement, and optimize processes across various engineering disciplines, including product evaluation, capability testing, equipment selection, and tooling development or modification.
• Analyze data to troubleshoot process issues, identify root causes, and recommend corrective actions.
• Establish strategic processing goals and integrate processes into value streams. Perform in-process and product-release testing.
• Prepare capital appropriation requests supported by validated testing and demonstrated feasibility.
• Collaborate with operators, technicians, and engineers to ensure products meet customer and quality requirements.
• Coordinate training and process transfer activities with production teams.
• Provide technical supervision or coordination for engineers, draftspersons, and technicians as needed.
• Ensure compliance with company safety and quality policies; lead by example.
• Conduct manufacturing reviews and pre-validation assessments to ensure safe and environmentally compliant process start-up.
• Document all activities according to engineering best practices, company procedures, and regulatory standards.
• Prepare technical reports independently.
• Conduct experiments, record procedures, collect data, and maintain accurate lab documentation.
• Set up, adjust, and operate basic R&D and manufacturing equipment.

Education and Experience

• Bachelor's degree in a relevant engineering discipline (Mechanical, Electromechanical, or Materials Engineering preferred).
• Experience with Catheters
• Experience in process development
• 4+ years of related professional experience; experience in the medical device industry and Six Sigma certification are strong assets.
• Proficient in standard computer applications, including email, record keeping, databases, word processing, spreadsheets, and graphics.
• Strong written and verbal communication skills in English (B2+)

Other Skills and Abilities

• Strong teamwork skills with the ability to work independently and with minimal supervision.
• Fast learner who seeks opportunities to expand technical knowledge and skills in industrial or engineering environments.
• Solid engineering foundation with understanding of basic project management principles.
• Developing competencies in problem-solving methodologies, team leadership, and coordination of complex tasks.
• Ability to read, analyze, and interpret scientific and technical journals, financial documents, and legal materials.
• Capable of responding professionally to inquiries from customers, regulatory agencies, and business stakeholders.
• Able to prepare written materials such as technical articles, presentations, or speeches following defined styles and formats.
• Strong presentation skills, including the ability to present to senior management, public groups, or boards of directors.
• Required knowledge of statistics and ability to apply mathematical concepts such as frequency distributions, test reliability, ANOVA, correlation, sampling theory, and factor analysis.
• Strong problem-solving ability, including handling practical issues where limited standardization exists.
• Able to interpret written, verbal, diagrammatic, and schedule-based instructions effectively.

This job description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent(s).