JOB TITLE: Senior Process Development Engineer

LOCATION: Hawthorne, NY (on-site)

TYPE: Full time, regular

COMPENSATION: $95,000 – $130,000/yr (depending on relevant experience)

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. We are looking for a team player who views medical device development as a competitive advantage.

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 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 will be 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 will be responsible for changing the standards of delivering healthcare