Contract - Manufacturing Engineer

Redline Group Ltd; Massachusetts; Hybrid; USD 83,000 - 124,000; Full time

Job summary

Redline Group Ltd. is seeking an experienced Manufacturing Engineer to support investment casting, mold-flow analysis and process qualification for orthopedic medical device components in Massachusetts. You will drive tooling optimization, DOE-based improvements, and validation activities in a regulated manufacturing setting.

The role requires hands-on casting experience, proficiency with ProCAST or MAGMASOFT, and a strong quality mindset to ensure regulatory compliance and product quality.

Qualifications

• Bachelor’s Degree in Mechanical Engineering, Manufacturing Engineering, Materials Engineering or a related discipline.
• Proven experience in Manufacturing/Process Engineering or Foundry Operations.
• Strong investment casting, casting process development or foundry experience.
• Experience with casting simulation and mold-flow analysis software such as ProCAST or MAGMASOFT.
• Knowledge of process qualification, validation and IQ/OQ/PQ methodologies.
• Proficiency in DOE, SPC, Cp/Cpk, statistical analysis and Minitab.
• Experience with CMM, GD&T, dimensional inspection and CTQ analysis.
• Knowledge of PFMEA, CAPA, process controls and root cause analysis.
• Experience working within a regulated manufacturing environment.
• Strong technical writing, problem-solving and stakeholder management skills.

Responsibilities

• Support investment casting operations, including wax pattern creation, shell building, casting, finishing and inspection activities.
• Develop, optimise and qualify casting processes, operating parameters and manufacturing work instructions.
• Troubleshoot casting defects, including porosity, shrinkage, inclusions, dimensional variation and yield loss.
• Perform dimensional analysis, process capability studies and statistical analysis using tools such as Minitab.
• Drive process improvements through DOE, SPC, Lean Manufacturing and Six Sigma methodologies.
• Conduct casting simulation and mold-flow analysis using ProCAST, MAGMASOFT or similar software.
• Correlate simulation data with production results to optimise tooling, gating, risers and manufacturing processes.
• Support IQ, OQ and PQ activities, including validation protocols, process characterisation and final reports.
• Work with suppliers on tooling development, process improvement and technical assessments.
• Support NPI, design transfer, manufacturing scale-up and engineering change activities.
• Participate in PFMEA, control plans, risk assessments, CAPA investigations and root cause analysis.
• Ensure compliance with FDA, ISO 13485, GMP and medical device quality requirements.

Skills

DOE

Six Sigma

Statistical analysis

Minitab

Education

Bachelor’s Degree in Mechanical Engineering

Tools

ProCAST

MAGMASOFT

Job description

Our client is an established engineering consultancy supporting Medical Device, Life Sciences, Pharmaceutical and Biopharmaceutical organisations across the United States.Their teams provide specialist expertise across Quality Engineering, Manufacturing Engineering, Supply Chain, Project Management, Validation and Regulatory Affairs, supporting both site-based and enterprise-wide programmes.

Typical project activity includes new product introduction (NPI), product development, quality remediation, CAPA, manufacturing improvement, operational readiness, process validation, regulatory compliance and business transformation initiatives.

As a result of increased project demand, they are seeking experienced contractors to support a range of ongoing and newly awarded programmes.

Manufacturing Engineer - Casting & Mold Flow Qualification

Location: Massachusetts

Duration: 12 months (W2 or C2C considered)

Hybrid - circa 2 days per month (dependent on project need - may increase when required)

Work Authorisation for US - no sponsorship offered

About the Role

We are seeking an experienced Manufacturing Engineer to support investment casting, process qualification and manufacturing validation activities for orthopedic medical device components.The successful candidate will play a key role in casting process development, mold flow analysis, tooling optimisation, process validation and continuous improvement initiatives within a regulated manufacturing environment.

Key Responsibilities

• Support investment casting operations, including wax pattern creation, shell building, casting, finishing and inspection activities.
• Develop, optimise and qualify casting processes, operating parameters and manufacturing work instructions.
• Troubleshoot casting defects, including porosity, shrinkage, inclusions, dimensional variation and yield loss.
• Perform dimensional analysis, process capability studies and statistical analysis using tools such as Minitab.
• Drive process improvements through DOE, SPC, Lean Manufacturing and Six Sigma methodologies.
• Conduct casting simulation and mold-flow analysis using ProCAST, MAGMASOFT or similar software.
• Correlate simulation data with production results to optimise tooling, gating, risers and manufacturing processes.
• Support IQ, OQ and PQ activities, including validation protocols, process characterisation and final reports.
• Work with suppliers on tooling development, process improvement and technical assessments.
• Support NPI, design transfer, manufacturing scale-up and engineering change activities.
• Participate in PFMEA, control plans, risk assessments, CAPA investigations and root cause analysis.
• Ensure compliance with FDA, ISO 13485, GMP and medical device quality requirements.

Required Experience

• Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Materials Engineering or a related discipline.
• Proven experience within Manufacturing Engineering, Process Engineering or Foundry Operations.
• Strong investment casting, casting process development or foundry experience.
• Experience with casting simulation and mold-flow analysis software such as ProCAST or MAGMASOFT.
• Knowledge of process qualification, validation and IQ/OQ/PQ methodologies.
• Proficiency in DOE, SPC, Cp/Cpk, statistical analysis and Minitab.
• Experience with CMM, GD&T, dimensional inspection and CTQ analysis.
• Knowledge of PFMEA, CAPA, process controls and root cause analysis.
• Experience working within a regulated manufacturing environment.
• Strong technical writing, problem-solving and stakeholder management skills.

We look forward to hearing from you.