Intellectt Inc
This range is provided by Intellectt Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base Pay Range $30.00/hr - $45.00/hr
Direct Message Direct message the job poster from Intellectt Inc
Job Title Manufacturing Engineer – Pharma / Medical Device
Job Location [Across US]
Contract [6-12 Months]
On‑site / Hybrid as applicable
Job Summary The Manufacturing Engineer will ensure that production of medical devices / pharmaceutical products is efficient, cost‑effective, and compliant with relevant regulatory requirements. This role bridges R&D / Process Development, Quality Assurance, Supplier Management, and Production. The ME is responsible for implementing and optimizing manufacturing processes, validation of equipment and processes, driving continuous improvement, and supporting new product introduction (NPI).
Key Responsibilities
Develop, implement, optimize, and validate manufacturing processes for medical devices / pharma, ensuring repeatability, robustness, and compliance.
Support process scale‑up from pilot / prototype to full scale production lines.
Lead equipment qualification / validation (IQ, OQ, PQ) and ensure validation compliance.
Conduct risk assessments (e.g. FMEA / pFMEA), perform process capability studies (SPC, MSA), and implement corrective actions (CAPA, root cause analysis).
Generate, maintain, and update process documentation – SOPs, batch records, work instructions, flow charts, DFM / design reviews, technical reports etc.
Collaborate with cross‑functional teams: R&D, Quality, Regulatory, Manufacturing, Supply Chain, Suppliers / Contract Manufacturers. Ensure that product and process design is manufacturable, cost‑optimized, and meets regulatory requirements.
Maintain compliance with quality systems and regulatory standards relevant to the industry: e.g., ISO 13485, FDA CFR Part 820, EU MDR for medical devices, cGMP for pharma.
Monitor process performance: yield, scrap, downtime, defect rates; drive continuous improvement and cost reduction initiatives (Lean, Six Sigma, design for manufacture / assembly (DFM/DFMA)).
Supplier / vendor management: work with suppliers to ensure they meet quality and process requirements; evaluate supplier capability; manage PPAP or equivalent process in med device industry.
Troubleshoot technical issues on the production floor; support maintenance, calibration, tool / fixture design, machine / process troubleshooting.
Support / lead New Product Introduction (NPI): pilot builds, process qualification, transition to full‑scale production.
Required Qualifications & Skills
Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, Chemical, Manufacturing or equivalent).
2‑6+ years of experience in manufacturing / process engineering, preferably in medical device or pharmaceutical regulated environment. (Adjust depending on seniority.)
Experience with validation (IQ / OQ / PQ) of equipment and processes.
Knowledge of regulatory standards and quality systems: ISO 13485, FDA 21 CFR Part 820, EU MDR, cGMP etc.
Strong statistical and analytical skills: SPC, DOE, process capability, measurement systems analysis (MSA), Gage R&R etc.
Experience in documentation: SOPs, batch / lot records, work instructions, change control, CAPA, non‑conformance etc.
Good knowledge or hands‑on with fixtures, tooling, automation, equipment installation & maintenance. CAD knowledge is a plus.
Seniority level Associate
Employment type Contract
Job function
Manufacturing and Quality Assurance
Industries Pharmaceutical Manufacturing and Biotechnology Research
Sign in to set job alerts for “Manufacturing Engineer” roles. Referrals increase your chances of interviewing at Intellectt Inc by 2x
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Base Pay Range $30.00/hr - $45.00/hr
Direct Message Direct message the job poster from Intellectt Inc
Job Title Manufacturing Engineer – Pharma / Medical Device
Job Location [Across US]
Contract [6-12 Months]
On‑site / Hybrid as applicable
Job Summary The Manufacturing Engineer will ensure that production of medical devices / pharmaceutical products is efficient, cost‑effective, and compliant with relevant regulatory requirements. This role bridges R&D / Process Development, Quality Assurance, Supplier Management, and Production. The ME is responsible for implementing and optimizing manufacturing processes, validation of equipment and processes, driving continuous improvement, and supporting new product introduction (NPI).
Key Responsibilities
Develop, implement, optimize, and validate manufacturing processes for medical devices / pharma, ensuring repeatability, robustness, and compliance.
Support process scale‑up from pilot / prototype to full scale production lines.
Lead equipment qualification / validation (IQ, OQ, PQ) and ensure validation compliance.
Conduct risk assessments (e.g. FMEA / pFMEA), perform process capability studies (SPC, MSA), and implement corrective actions (CAPA, root cause analysis).
Generate, maintain, and update process documentation – SOPs, batch records, work instructions, flow charts, DFM / design reviews, technical reports etc.
Collaborate with cross‑functional teams: R&D, Quality, Regulatory, Manufacturing, Supply Chain, Suppliers / Contract Manufacturers. Ensure that product and process design is manufacturable, cost‑optimized, and meets regulatory requirements.
Maintain compliance with quality systems and regulatory standards relevant to the industry: e.g., ISO 13485, FDA CFR Part 820, EU MDR for medical devices, cGMP for pharma.
Monitor process performance: yield, scrap, downtime, defect rates; drive continuous improvement and cost reduction initiatives (Lean, Six Sigma, design for manufacture / assembly (DFM/DFMA)).
Supplier / vendor management: work with suppliers to ensure they meet quality and process requirements; evaluate supplier capability; manage PPAP or equivalent process in med device industry.
Troubleshoot technical issues on the production floor; support maintenance, calibration, tool / fixture design, machine / process troubleshooting.
Support / lead New Product Introduction (NPI): pilot builds, process qualification, transition to full‑scale production.
Required Qualifications & Skills
Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, Chemical, Manufacturing or equivalent).
2‑6+ years of experience in manufacturing / process engineering, preferably in medical device or pharmaceutical regulated environment. (Adjust depending on seniority.)
Experience with validation (IQ / OQ / PQ) of equipment and processes.
Knowledge of regulatory standards and quality systems: ISO 13485, FDA 21 CFR Part 820, EU MDR, cGMP etc.
Strong statistical and analytical skills: SPC, DOE, process capability, measurement systems analysis (MSA), Gage R&R etc.
Experience in documentation: SOPs, batch / lot records, work instructions, change control, CAPA, non‑conformance etc.
Good knowledge or hands‑on with fixtures, tooling, automation, equipment installation & maintenance. CAD knowledge is a plus.
Seniority level Associate
Employment type Contract
Job function
Manufacturing and Quality Assurance
Industries Pharmaceutical Manufacturing and Biotechnology Research
Sign in to set job alerts for “Manufacturing Engineer” roles. Referrals increase your chances of interviewing at Intellectt Inc by 2x
#J-18808-Ljbffr