Manufacturing Engineer at Stark Pharma Solutions Inc Pennsylvania

Comunidade Metodista; Pennsylvania; On-site; USD 80,000 - 110,000; Full time

Job summary

Stark Pharma Solutions Inc. in Bristol, PA seeks an experienced Manufacturing Engineer to own and optimize processes for high-precision medical/aerospace components.

You will drive efficiency, quality, and continuous improvement through Lean and Six Sigma, working across machining, molding, assembly, finishing, and packaging. The role demands hands-on process development, PFMEA/control plans, capital equipment involvement, and mentorship of production teams to ensure on-time delivery and

Qualifications

• Bachelor's degree in Manufacturing, Industrial, or Mechanical Engineering or related field.

Responsibilities

• Develop, implement, and maintain optimized manufacturing processes and inspection methods aligned with specs and quality standards.
• Lead continuous improvement projects using Lean Manufacturing and Six Sigma to enhance productivity and reduce waste.
• Partner with Quality Engineering to design tooling, fixtures, and gauges supporting zero-defect manufacturing.
• Support creation and maintenance of PFMEAs and control plans for consistent process quality.
• Estimate resources, production times, and costs to support strategic planning and decisions.
• Document and qualify manufacturing procedures per regulatory and internal standards.
• Assist in capital equipment justifications for process improvements.
• Provide training and mentorship on new processes to production teams.
• Troubleshoot production issues to maintain on-time delivery and efficiency.
• Lead root cause analysis and CAPA for process nonconformances.
• Plan IQ/OQ/PQ and other validation activities for new/modified processes.
• Manage Lean projects focusing on workflow, waste reduction, and standardization.
• Perform other duties to support production goals.

Skills

Manufacturing processes

Lean Six Sigma

CNC programming

GD&T

Blueprint reading

CAD/CAM software

Education

Bachelor's degree in Manufacturing/Industrial/Mechanical Engineering

Tools

Mastercam

SolidWorks

CREO/ProE

Job description

Manufacturing Engineer job at Stark Pharma Solutions Inc. Pennsylvania.

Job Title: Manufacturing Engineer
Location: Bristol, PA
Experience Required: 3+ years
Employment Type: 12+ months contract

Job Summary

This role is ideal for an experienced Manufacturing Engineer who can take ownership of developing, optimizing, and maintaining manufacturing processes for high-precision components used in medical and aerospace applications. The position focuses on improving production efficiency, ensuring product quality, and supporting continuous improvement through Lean and Six Sigma principles. The engineer will work hands-on across machining, molding, assembly, finishing, and packaging operations to drive process excellence and manufacturing innovation.

Key Responsibilities

• Develop, implement, and maintain optimized and cost-effective manufacturing processes and inspection methods aligned with product specifications and quality standards.

• Lead continuous improvement projects using Lean Manufacturing and Six Sigma methodologies to enhance productivity and reduce waste.

• Partner with Quality Engineering to design robust tooling, fixtures, and gauges supporting zero-defect manufacturing.

• Support creation and maintenance of PFMEAs and control plans to ensure consistent process quality.

• Estimate resources, production times, and costs to support strategic planning and operational decisions.

• Document and qualify manufacturing and inspection procedures per regulatory and internal standards.

• Participate in and help justify capital equipment purchases for process improvement initiatives.

• Provide technical training and mentorship to production teams on new or improved manufacturing processes.

• Troubleshoot and resolve production issues to maintain on-time delivery and improve operational efficiency.

• Lead root cause analysis and CAPA (Corrective and Preventive Actions) for process-related nonconformances.

• Plan and execute IQ/OQ/PQ and other process validation activities for new or modified processes.

• Manage and execute Lean projects focused on workflow optimization, waste reduction, and process standardization.

• Perform other engineering duties as assigned by management to support production goals and business needs.

Required Qualifications

• Bachelor's degree in Manufacturing, Industrial, or Mechanical Engineering (or a related technical field).

• Minimum of 3 years of hands‑on experience in a manufacturing environment - preferably in machining, sheet metal fabrication, plastics, or assembly.

• Strong background in high‑precision machining or assembly operations.

• Proven ability to develop and optimize manufacturing processes using Lean and Six Sigma methodologies.

• Experience with Mastercam, SolidWorks, CREO/ProE, or similar CAD/CAM software.

• Proficiency in blueprint reading and Geometric Dimensioning and Tolerancing (GD&T).

• Working knowledge of CNC programming and machine setup preferred.

• Experience in secondary processes such as welding, polishing, passivation, or electro‑polishing is desirable.

• Skilled in fixture design, tooling selection, and process validation techniques.

• Familiarity with quality control systems, documentation, and regulatory requirements for medical or aerospace manufacturing.

• Strong analytical and statistical analysis skills; Six Sigma Green Belt certification is a plus.

• Excellent communication, organizational, and problem‑solving skills.

• Collaborative, self‑driven, and capable of managing multiple priorities in a fast‑paced environment.