Senior Process Development Engineer
Location:
Hawthorne, NY
Pay:
$95,000 - $130,000 depending on experience
Type: Direct
NOTE: Enser is an Engineering Services Company that provides Staffing Support. This position is not internal to Enser. Please No Agencies.
Position Summary:
The
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.
Key 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
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