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Process Engineer Medical Device Jobs (NOW HIRING)

IT MINDS L.L.C.

Quality Engineer - Medical Device

Newark, DE · On-site

$70K - $90K/yr

Quality Engineer - Medical Device Location: Delaware Largescale Medical Device client facing a ... Perform detailed reviews of production line documentation, including: o Process documentation o ...

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

As of Aug 16, 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 is a process engineer medical device?

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.

What does a process engineer medical device do?

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 skills and qualifications are needed to thrive as a process engineer medical device?

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.

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What states have the most Process Engineer Medical Device jobs?

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Process Engineer Medical Device jobs near you
Infographic showing various Process Engineer Medical Device job openings in the United States as of August 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 Engineer - Medical Device

Katalyst Healthcares and Lifesciences

Tonawanda, NY • On-site

Other

Posted 2 days ago

New

Job description

Summary :
Key Responsibilities :
  • Design, develop, and optimize manufacturing processes for medical devices.
  • Execute Design of Experiments (DOE) to improve process performance.
  • Perform process characterization and statistical analysis (e.g., using MINITAB).
  • Collaborate with cross-functional teams including Engineering, Quality, and Operations.
  • Support process documentation for regulatory compliance (FDA, ISO 13485).
  • Identify process improvements and implement corrective actions.
  • Strong knowledge of process engineering principles in a medical device environment.
  • DOE and statistical analysis experience (MINITAB or similar tools).
  • Familiarity with process validation and qualification.
  • Understanding of regulatory standards: FDA, ISO 13485, GMP.
  • Excellent problem-solving, communication, and collaboration skills.

Education & Experience :
  • Previous experience in process optimization and continuous improvement in a regulated environment.
  • Experience with manufacturing equipment selection, setup, and troubleshooting.
  • Knowledge of lean manufacturing and Six Sigma methods.

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