Sr. Process development Engineer

$95,000 - $130,000/Yr

Enser Corporation - Hawthorne, NY

Full-time - Senior

Hawthorne, NY

Professional, Scientific, and Technical Services

About the position

The Senior Process Development Engineer will formalize the company's production processes and procedures, focusing on continuous productivity and quality improvements. This role is essential for driving continuous improvement initiatives, troubleshooting production issues, and collaborating with cross-functional teams. The ideal candidate will have a comprehensive understanding of all aspects of medical device development, viewing it 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

Requirements

• 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

Nice-to-haves

• Six-sigma training preferred

Benefits

• 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 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