Process Development Engineer II
hace 3 días
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 II join our team in Costa Rica.
Summary of Essential Duties and Responsibilities
- Lead and execute process development from concept and prototype stages through validation and sustained manufacturing.
- Plan, coordinate, and perform engineering activities supporting standard production and new product introductions.
- Develop, evaluate, and implement manufacturing processes, equipment, and tooling to ensure efficiency and quality.
- Analyze process data, identify root causes of issues, and recommend corrective actions for continuous improvement.
- Support equipment and tooling modifications to enhance process capability and performance.
- Prepare and justify capital appropriation requests based on feasibility and testing data.
- Collaborate with cross-functional teams—operators, technicians, and engineers—to deliver products that meet customer and regulatory requirements.
- Train and support production teams during process transfers and manufacturing ramp-up.
- Document engineering activities, validations, and results per company procedures and regulatory standards.
- Conduct experiments, collect and analyze data, and prepare technical reports with minimal supervision.
- Ensure compliance with safety, quality, and environmental standards during new process start-up and ongoing operations.
- May supervise or coordinate technical staff involved in assigned projects.
Required Education and Experience
- Bachelor's degree in a relevant engineering discipline (Chemistry, Materials, or Mechanical Engineering preferred).
- Minimum of 2 years of related work in the medical device industry.
- Six Sigma certification
- Experience in transfers and process development
- Experience in problem solving, design of experiments and reviewing product specifications, are considered strong assets.
- English communication skills (preferably B2)
Other Skills and Abilities
- Demonstrated ability to work independently and collaboratively in cross-functional teams.
- Quick learner who proactively seeks opportunities to expand technical knowledge.
- Solid understanding of engineering principles and basic project management fundamentals.
- Developing skills in problem-solving, team leadership, and complex coordination.
- Proficient in statistical analysis and data interpretation (e.g., ANOVA, correlation, sampling, and reliability testing).
- Ability to analyze technical and scientific information, prepare technical reports, and present findings effectively to varied audiences.
- Strong critical thinking and troubleshooting skills with the ability to adapt to non-standardized situations.
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).
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