Development Process Engineer

Lead the design, development, and implementation of new manufacturing processes and equipment.

Specify, acquire, and validate new equipment to support production and process improvements.

* Lead the design, development, and implementation of new manufacturing processes and equipment.

* Specify, acquire, and validate new equipment to support production and process improvements.

* Apply structured problem-solving methodologies to identify root causes of process issues.

* Develop and implement corrective and preventive actions (CAPAs).

* Design and execute experiments (DOE), analyze data, and present findings to cross-functional teams.

* Drive continuous improvement initiatives to enhance product quality, reduce waste, and increase efficiency.

* Create and maintain technical documentation including SOPs, risk assessments, validation protocols, and safety instructions.

* Ensure all processes comply with internal quality systems and external regulatory requirements.

* Work closely with R&D, Quality, Manufacturing, and Supply Chain teams to support product development and scale-up.

* Provide technical training and mentorship to technicians and junior engineers.

* Evaluate and recommend new materials, tools, and technologies to improve manufacturing capabilities.

* Support tooling development and process validation for new and existing products.

* Bachelor's degree in engineering (Mechanical, Biomedical, Chemical, or related field) with 2-5+ years of relevant experience OR master's degree with 0-2 years of experience or an equivalent combination of education and experience.

* Strong analytical and problem-solving skills.

* Proficiency in technical writing and documentation.

* Ability to work independently and collaboratively in cross-functional teams.

* Excellent communication and presentation skills.

* Working knowledge of manufacturing systems, automation, and process control.

* Experience in the medical device industry, particularly with catheter manufacturing or similar regulated environments.

* Familiarity with GMP, ISO 13485, and FDA regulations.

* Hands-on experience with process validation, DOE, and statistical analysis.