Job Description Job Description Job Title: Sr. Manufacturing Engineer Location: Hicksville, New York Reports To: Engineering Manager Schedule: Monday-Friday, Full time on site Salary: 115,000-130,000 depending on experience Benefits: Medical, Dental, Vision, 401k with match, PTO, Vacation, etc. Position Summary The Manufacturing Engineer is responsible for developing, implementing, and sustaining efficient, compliant, and cost-effective manufacturing processes in a contract manufacturing environment. This role supports a wide range of processes including CNC machining, finishing, secondary operations, and small mechanical assemblies for complex components. The Manufacturing Engineer ensures compliance with FDA Quality System Regulations (21 CFR Part 820) and ISO 13485 standards while leading process optimization, supporting quotations, and driving continuous improvement initiatives across the value stream. Key Responsibilities Process Development & Optimization Develop, validate, and optimize CNC machining, finishing, assembly, and other special processes to meet tight tolerances and regulatory requirements. Lead value stream mapping initiatives to identify waste, streamline workflows, and improve throughput. Facilitate process FMEAs (pFMEA) to proactively identify and mitigate risks. Provide Design for Manufacturability (DFM) feedback during new product introduction and design transfer activities. Quoting & Costing Support Assist in quotation and estimating processes by analyzing manufacturing feasibility, cycle times, tooling requirements, and capacity. Partner with sales, project management, and production teams to ensure accurate and competitive proposals. Compliance & Documentation Ensure all manufacturing processes and documentation comply with FDA QSR, ISO 13485, and internal quality system requirements. Author and maintain manufacturing documentation including work instructions, process flow diagrams, PFMEAs, control plans, and validation protocols/reports. Support internal and external audits, including regulatory and customer audits. Validation & Qualification Develop and execute equipment qualifications (IQ/OQ/PQ) and process validation protocols in compliance with regulatory standards. Collaborate with Quality Engineering to establish process controls, SPC, and robust monitoring systems. Continuous Improvement & Problem Solving Drive Lean Six Sigma projects to reduce variation, improve yield, and lower manufacturing costs. Lead structured root cause investigations and implement corrective and preventive actions (CAPA). Champion continuous improvement culture across all manufacturing processes. Technical Support & Collaboration Provide hands-on support to production teams for troubleshooting process and equipment issues. Train operators and technicians on new processes, equipment, and standards. Collaborate with suppliers, toolmakers, and equipment vendors to qualify and integrate new technologies. Qualifications Education: Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or related field. Experience: 5-7 years of experience in manufacturing engineering within a regulated environment (medical device or aerospace preferred) Experience across a wide range of manufacturing processes including CNC machining (multi-axis milling/turning), finishing, deburring, cleaning, passivation, and small assembly. Strong background in process validation (IQ/OQ/PQ) and regulatory compliance (FDA QSR & ISO 13485) or at least ISO 9001. Technical Skills: Proficient in CAD/CAM and GD&T. Knowledge of value stream mapping, FMEA, Lean Manufacturing, Six Sigma, and SPC. Ability to support quotation processes with accurate cycle time and cost analysis. Other Skills: Excellent documentation, communication, and cross-functional teamwork skills. Ability to manage multiple projects in a fast-paced, contract manufacturing environment. Strong problem-solving, analytical, and leadership skills. Pay Details: $115,000.00 to $130,000.00 per year Search managed by: Cara Kelly Equal Opportunity Employer/Veterans/Disabled Military connected talent encouraged to apply To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to uat.lhh.com/us/en/candidate -privacy The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for Employers San Francisco Fair Chance Ordinance Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.6b250ea6-cee3-481d-915c-f7283f1b2f1b
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