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Process Engineer Medical Device Jobs (NOW HIRING)

Intellectt INC

Process Engineer

Kansas City, KS · On-site

We are seeking a Process Engineer with 3-7 years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments. The role will support manufacturing ...

Tekhawks LLC

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Validation Engineer - (Medical Device, Pharma)

Jacksonville, FL · On-site

$35 - $40/hr

... level Validation Engineers to support a large capital expansion at a leading medical device ... process validation * Strong understanding of FDA regulations, 21 CFR Part 820, and GDP/GMP ...

Tekhawks LLC

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Validation Engineer - (Medical Device, Pharma)

Jacksonville, FL · On-site

$35 - $40/hr

... level Validation Engineers to support a large capital expansion at a leading medical device ... process validation * Strong understanding of FDA regulations, 21 CFR Part 820, and GDP/GMP ...

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How much do process engineer medical device jobs pay per year?

As of Jul 7, 2026, the average yearly pay for process engineer medical device in the United States is $92,018.00, according to ZipRecruiter salary data. Most workers in this role earn between $74,500.00 and $103,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in the Process Engineer Medical Device position, and why are they important?

A Process Engineer in Medical Devices typically requires a degree in engineering (such as chemical, biomedical, or mechanical engineering) and experience with manufacturing processes, quality systems, and regulatory compliance. Familiarity with tools like CAD software, statistical analysis programs, lean manufacturing techniques, and knowledge of standards such as ISO 13485 are common requirements. Strong problem-solving abilities, project management skills, and excellent communication facilitate successful interactions with cross-functional teams. These skills ensure efficient, high-quality, and compliant manufacturing processes critical to patient safety and company success.

What are some common projects or responsibilities I might take on as a Process Engineer in the medical device industry?

As a Process Engineer in the medical device industry, you'll commonly work on projects such as optimizing manufacturing processes, implementing new technologies, and ensuring compliance with strict quality and regulatory standards. Your daily tasks may include designing and validating production methods, troubleshooting process issues, and collaborating closely with quality assurance, R&D, and production teams. You may also be involved in documentation, process scale-up for new products, and continuous improvement initiatives. The role is highly collaborative, requiring you to coordinate with both technical and non-technical staff to meet quality, efficiency, and regulatory goals.

What is a Process Engineer Medical Device job?

A Process Engineer in the medical device industry is responsible for designing, implementing, and optimizing manufacturing processes to ensure efficiency, quality, and compliance with regulatory standards. They work to improve production procedures, troubleshoot issues, and develop new process technologies. Their role involves collaborating with cross-functional teams, such as design, quality, and regulatory, to ensure medical devices meet industry requirements. Additionally, they analyze data, validate processes, and support continuous improvement initiatives to enhance product reliability and manufacturing scalability.

More about Process Engineer Medical Device jobs
What cities are hiring for Process Engineer Medical Device jobs? Cities with the most Process Engineer Medical Device job openings:
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What job categories do people searching Process Engineer Medical Device jobs look for? The top searched job categories for Process Engineer Medical Device jobs are:
Process Engineer Medical Device jobs near you
Infographic showing various Process Engineer Medical Device job openings in the United States as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $92,018 per year, or $44.2 per hour.

Process Validation Engineer/Manufacturing Engineer - Medical Device

Stark Pharma Solutions Inc

Raynham, MA • On-site

Contractor

Posted 8 days ago

Job description

Job Title: Senior Process Validation Engineer

Location: Raynham, MA (Onsite – Local candidates preferred)

Type: Contract (1 year + long-term extensions)

Industry: Medical Device Manufacturing | Supply Chain Quality

Job Summary:

We are seeking a Senior Process Validation Engineer to support the startup and qualification of a new Class III medical device manufacturing facility. This role will be part of the Supply Chain Quality team and will lead critical validation and quality activities to ensure compliant and efficient manufacturing operations.

The ideal candidate will bring strong expertise in process validation, equipment qualification, and inspection readiness, working closely with cross-functional teams in a highly regulated environment.

Key Responsibilities

  • Lead process qualification and validation activities to ensure manufacturing processes are robust and compliant
  • Plan and execute IQ, OQ, PQ, and process validation activities
  • Develop validation strategies, protocols, reports, and documentation (including URS)
  • Support inspection readiness by ensuring Critical-to-Quality (CTQ) characteristics are verified using qualified methods
  • Perform test method validation and measurement system analysis (e.g., Gauge R&R)
  • Provide Quality oversight for validation documentation and approvals
  • Support deviation investigations, root cause analysis, and troubleshooting
  • Collaborate with Manufacturing, Engineering, Supply Chain, and R&D teams to meet project timelines

Required Qualifications

  • 5+ years of hands-on experience in process validation within regulated environments (GMP/ISO)
  • 4+ years of experience in Quality, Supply Chain, or R&D within medical devices or similar industries
  • Strong expertise in IQ/OQ/PQ, process verification, and validation documentation
  • Experience with CNC machining processes and Coordinate Measuring Machines (CMM)
  • Experience in risk management (FMEA)
  • Strong communication, collaboration, and project management skills