JOB TITLE: Senior Process Development Engineer

LOCATION: Hawthorne, NY (on-site)

TYPE: Full time, regular

COMPENSATION: $95,000-$130,000/yr

Clarapath is a medical robotics company based in Westchester County, NY. Our mission is to transform and modernize laboratory workflows with the goal of improving patient care, decreasing costs, and enhancing the quality and consistency of laboratory processes. SectionStar™ by Clarapath is a ground-breaking electro-mechanical system designed to elevate and automate the workflow in histology laboratories and provide pathologists with the tissue samples they need to make the most accurate diagnoses. Through the use of innovative technology, data, and precision analytics, Clarapath is paving the way for a new era of laboratory medicine.

Role Summary:

The Senior Process Development Engineer will formalize the company’s production processes and procedures and strive for continuous productivity and quality improvements/enhancements. This position will be crucial in driving continuous improvement initiatives, troubleshooting production issues, and collaborating with cross-functional teams. The person will be expected to fully understand all aspects of the device.

Responsibilities:

• Maintain accurate and up-to-date documentation of production processes, changes and improvements
• Liaise with engineering to create and maintain current documentation of designs, tool drawings and work instructions
• Work with engineering on engineering change order implementation to ensure that all ECOs are closed in a timely manner
• Create process maps, PFMEAs, IQ OQ PQ, process implementation documentation, and create DHRs
• Develop manual assembly processes, assembly fixtures and test procedures and implement process improvements
• Troubleshoot assembly issues as they arise and implement corrective actions
• Drive creation of tests across electro-mechanical assemblies to assure sufficient quality before final assembly
• Review internal operational facility layouts for process improvement
• Establish and enforce quality control standards
• Implement corrective actions and preventive measures to enhance product quality
• Lead production implementation procedures across multiple departments and train operators on change processes
• Work with Quality Assurance to develop jigs and fixtures to accelerate the inspection process
• Ensure compliance with industry regulations and safety standards

Qualifications:

• Minimum of Bachelor's degree in Mechanical Engineering, Manufacturing Engineering or related engineering field
• 10 years experience working in a manufacturing/production environment with evidence of experience in manual assembly
• Strong knowledge of production processes, quality management, and continuous improvement methodologies
• Experience in reading electrical and wiring diagrams
• Proficiency in using production planning and ERP systems
• Solid knowledge of ISO standards
• Strong leadership, communication and collaboration skills
• Excellent analytical and problem-solving skills
• Strong passion for product and process excellence
• Six-sigma training preferred

Company Offers:

• Competitive salary commensurate with experience and education
• Comprehensive benefits package available:(healthcare, vision, dental and life insurances; 401k; PTO and holidays)
• A collaborative and diverse work environment where our teams thrive on solving complex challenges
• Ability to file IP with the company
• Connections with world class researchers and their laboratories
• Collaboration with strategic leaders in healthcare and pharmaceutical world
• A mission driven organization where every team member is responsible for changing the standards of delivering healthcare

Clarapath is proud to be an equal opportunity employer. We are committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. In addition to federal law requirements, Clarapath complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.