Job Description
Position Title: Manufacturing Engineer
Position Description : Protingent Staffing has an exciting Direct Hire opportunity for a Manufacturing Engineer with our client that is in Plainview, NY.
Key areas of experience we’re looking for include:
- Mechanical assemblies and precision component handling
- Finishing operations for metal and plastic components (cleaning, passivation, electropolishing, etc.)
- Heat treating and surface finishing processes
- Medical device packaging and related quality requirements
- Strong familiarity with PPQP (Pre-Production Quality Planning) and other process validation activities (IQ, OQ, PQ)
- Lean Six Sigma Green Belt or Black Belt certification (preferred)
Job Description:
- 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 variation of manufacturing processes, including CNC machining, finishing, secondary operations, and small mechanical assemblies for complex medical device 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.
Job Responsibilities:
- Process Development & Optimization:
- Develop, validate, and optimize CNC machining, finishing, assembly, and other special processes to meet tight tolerances and medical device requirements.
- Lead value stream mapping initiatives to identify waste, streamline workflows, and improve throughput.
- Lead and facilitate process FMEAs (pFMEA) to proactively identify and mitigate process risks.
- Provide 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 customer 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 FDA, ISO, 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 a continuous improvement culture across all manufacturing processes.
- Technical Support & Cross-Functional 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.
Job Qualifications:
- Education: Bachelor’s degree in manufacturing engineering, Mechanical Engineering, Industrial Engineering, or related field.
- 3–7 years of experience in manufacturing engineering within a regulated environment (medical device 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).
- 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.
- 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.
Job Details:
- Job Type: Direct Hire
- Salary Rate Range: $110-130K
- Location: Plainview, New York.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.
Job Tags
Contract work,