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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

Process Validation & Equipment Qualification • Support process validation activities including: o IQ/OQ/PQ execution o Equipment qualification documentation o Validation protocol review and ...

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

As of Jun 13, 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.

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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 June 2026, with employment types broken down into 80% Full Time, and 20% Contract. Highlights an 100% In-person job distribution, with an average salary of $92,018 per year, or $44.2 per hour.

Manufacturing Process Engineer - Medical Device

Micro Manufacturing Solutions for Life

Somerset, NJ • On-site

Full-time

Posted 17 days ago

Job description

The Process Engineer ensures manufacturing processes are efficient, cost-effective, compliant with MICRO's quality standards, and capable of consistently producing products that meet customer specifications.
JOB OUTCOMES
The Process Engineer will:
• Lead projects that deliver measurable improvements in process efficiency, product quality, and cost reduction across assigned manufacturing areas.
• Act as a Subject Matter Expert (SME) to resolve complex technical challenges, optimize process performance, and support cross-functional teams.
• Drive sustainable process improvements through data-driven decision-making, root cause analysis, and the implementation of corrective and preventive actions.
• Ensure that manufacturing processes consistently meet internal quality standards and customer specifications while remaining scalable and cost-effective.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Process Improvement - 60%
  • Lead or actively contribute to cross-functional project teams focused on improving process efficiency, product quality, and cost performance.
  • Recommend and implement improvements to equipment, tooling, and work methods to increase throughput and optimize resource utilization.
  • Collaborate in the design and specification of new equipment and tooling to meet production and quality requirements.
  • Support the installation, testing, and optimization of new or modified equipment to ensure successful integration into manufacturing operations.
  • Assist in developing and refining manufacturing processes to improve repeatability, yield, and operational reliability.
  • Conduct root cause analyses of process issues and partner with Quality Engineers to implement sustainable corrective and preventive actions.

Process Analysis & Documentation - 40%
  • Collect and analyze production and process data to identify trends, deviations, and improvement opportunities.
  • Create clear, accurate process documentation including diagrams, workflows, and written instructions.
  • Draft and revise detailed work instructions and standard operating procedures (SOPs) with input from senior engineers.
  • Contribute to the development of validation documentation for new parts, design changes, and process updates.
  • Assist in managing nonconforming material by documenting issues, coordinating evaluations, and supporting disposition activities.
  • Interpret and apply tools such as Process Flow Diagrams (PFDs), Failure Mode and Effects Analyses (FMEAs), and Process Control Plans (PCPs) to ensure process control and risk mitigation.

TALENT MANAGEMENT
This position has no talent management responsibilities.
QUALIFICATIONS
EDUCATION AND EXPERIENCE
• Bachelor's degree in Engineering or a related field is required.
• At least 4-6 years of engineering experience is required.
LICENSE AND CERTIFICATION
• None
TECHNICAL SKILLS
• Blueprint reading
• Geometric Dimensioning and Tolerancing (GD&T)
• Statistical Process Control (SPC)
• Measurement Systems Analysis (MSA, GR&R)
• Design of Experiments (DOE)
• Statistical software systems
• ERP
• Minitab Statistical Software
• Metal fabrication
• Medical device manufacturing
• MS Office Suite
OTHER SKILLS
• Verbal communication
• Written communication
• Organizational skills
• Problem solving
While performing the duties of this Job, the employee is regularly required to sit; and talk and hear. The employee is frequently required to stand; walk; use hands to touch, handle, or feel and reach with hands and arms.
The employee must lift, push, pull, carry and/or move up to 10 pounds frequently, and between 10 and 25 pounds occasionally.
While performing this Job, the employee is regularly required to demonstrate manual and spatial dexterity sufficient to operate machinery for precision work.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
While performing the duties of this Job, the employee is regularly exposed to moving mechanical parts. The employee is frequently exposed to vibration. The employee is occasionally exposed to wet and/or humid conditions; risk of electrical shock; and odors, dusts, mists, fumes and/or airborne particles.
The noise level in the work environment varies from moderate to loud, based on the department/ work area.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.

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