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Mechanical Design Engineer Medical Device Jobs (NOW HIRING)

You'll work on complex systems that require innovative engineering solutions and have the ... Experience: 10+ years of experience in mechanical design, specifically in the medical device ...

Senior Mechanical Design Engineer

San Mateo, CA · On-site

$102K - $141K/yr

As Senior Mechanical Design Engineer, you will be a key driver in the design, development, and ... Has taken a Class II medical device all the way from initial design through FDA 510k approval and ...

Lead and execute mechanical design and development activities for medical device components, assemblies, and systems using SolidWorks and established engineering methodologies, including plastic ...

$120 - $150/hr

Lead and execute mechanical design and development activities for medical device components, assemblies, and systems using SolidWorks and established engineering methodologies, including plastic ...

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Senior Mechanical Engineer - Medical Device San Diego, CA (Onsite) 130,000-180,000 DOE Join a ... What you'll do: · Design and improve precision mechanical components, assemblies, and test ...

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Mechanical Design Engineer Medical Device information

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$45.5K

$91.6K

$136.5K

How much do mechanical design engineer medical device jobs pay per year?

As of Sep 6, 2026, the average yearly pay for mechanical design engineer medical device in the United States is $91,578.00, according to ZipRecruiter salary data. Most workers in this role earn between $76,000.00 and $103,000.00 per year, depending on experience, location, and employer.

What does a mechanical design engineer do in the medical device industry?

A Mechanical Design Engineer in the medical device industry is responsible for designing, developing, and testing mechanical components and systems that are integral to medical devices. They collaborate with cross-functional teams to ensure that products meet regulatory standards, are safe for patient use, and perform as intended. Their work involves using CAD software, prototyping, and conducting various analyses to optimize device functionality and manufacturability. They also play a key role in documentation and supporting the regulatory approval process.

What are some unique challenges mechanical design engineers face when developing medical devices?

Mechanical Design Engineers in the medical device industry often work under strict regulatory and quality standards, such as ISO 13485 and FDA guidelines. A key challenge is balancing innovative design with patient safety and manufacturability, which requires close collaboration with cross-functional teams like quality assurance, regulatory affairs, and clinical specialists. Additionally, engineers must frequently iterate their designs based on rigorous testing and feedback, ensuring the final product meets both functional and compliance requirements. This environment demands strong attention to detail, adaptability, and excellent communication skills.

What are the key skills and qualifications needed to thrive as a mechanical design engineer in medical devices, and why are they important?

To excel as a Mechanical Design Engineer in Medical Devices, you need a solid background in mechanical engineering principles, proficiency in CAD software, and experience with medical device regulations, often supported by a bachelor's degree in mechanical engineering or a related field. Familiarity with tools like SolidWorks, FEA analysis software, and knowledge of standards such as ISO 13485 and FDA requirements is crucial. Strong problem-solving abilities, attention to detail, and effective teamwork and communication skills help distinguish top performers. These skills ensure the development of safe, reliable, and compliant medical devices that meet both user needs and regulatory standards.

What is the difference between Mechanical Design Engineer Medical Device vs Mechanical Engineer?

AspectMechanical Design Engineer Medical DeviceMechanical Engineer
CredentialsBachelor's or Master's in Mechanical Engineering, certifications in medical device designBachelor's or Master's in Mechanical Engineering, professional engineering license (PE) optional)
Work EnvironmentMedical device companies, regulated environments, cleanroomsManufacturing, automotive, aerospace, general engineering firms
Industry UsageFocused on designing and developing medical devices and equipmentDesigns mechanical systems across various industries

The main difference is that a Mechanical Design Engineer Medical Device specializes in creating medical devices within regulated environments, requiring knowledge of medical standards and compliance. In contrast, a Mechanical Engineer has a broader scope across multiple industries without specific focus on medical regulations.

More about Mechanical Design Engineer Medical Device jobs

What job categories do people searching Mechanical Design Engineer Medical Device jobs look for?

The top searched job categories for Mechanical Design Engineer Medical Device jobs are:

Infographic showing various Mechanical Design Engineer Medical Device job openings in the United States as of August 2026, with employment types broken down into 55% Full Time, and 45% Contract. Highlights an 91% In-person, and 9% Hybrid job distribution, with an average salary of $91,578 per year, or $44 per hour.

Mechanical Design Engineer - NPD (Medical Device)

Siri InfoSolutions Inc

Irvine, CA • On-site

$81K - $110K/yr

Contractor

Posted 16 days ago


Job description

Job Title: New Product Development (NPD) Engineer – Medical Devices

Location: Irvine, CA 92618
Experience: 5–8 years
Industry: Medical Devices

Job Summary

We are looking for an experienced NPD Engineer to support the development and design of electro-mechanical systems and components for medical device products. The ideal candidate will have strong experience in New Product Development, electro-mechanical design, automation, CAD, and medical device regulatory requirements.

Key Responsibilities

Design and develop electro-mechanical systems, assemblies, and components for new products.

Perform system integration of mechanical and electrical components.

Identify and apply stepper motors, motor drivers, sensors, and PLC programming in product designs.

Support mechanical, electromechanical, and developmental design activities with limited supervision.

Contribute to New Product Development (NPD) projects from concept through development.

Work with industrial automation, robotics, and precision instruments.

Create and modify designs using SolidWorks/CAD and apply GD&T principles.

Support design activities in compliance with Good Manufacturing Practices (GMP) and applicable medical device standards.

Apply knowledge of ISO 13485, Medical Device Regulatory Standards, MDD, and MDR.

Utilize statistical analysis and Design of Experiments (DOE) techniques where applicable.

Prepare and maintain engineering documentation and project-related records.

Collaborate with cross-functional teams including engineering, quality, manufacturing, and project management.

Must-Have Skills

Bachelor's degree in Engineering, Mechanical, Biomedical, Mechatronics, or Electromechanical Engineering.

5–8 years of technical/engineering experience, preferably in NPD and the medical device industry.

Strong experience in product development / New Product Development (NPD).

Hands-on experience with electro-mechanical system and component design.

Experience with SolidWorks/CAD and GD&T.

Knowledge of PLC programming, stepper motors, motor drivers, and sensors.

Experience with industrial automation, robotics, or precision instruments is a plus.

Knowledge of GMP and medical device regulatory requirements.

Working knowledge of ISO 13485, MDD, MDR, and related medical device standards.

Knowledge of DOE and statistical analysis is preferred.

Strong project planning, organizational, communication, and interpersonal skills.

Proficiency with Microsoft Office, Word, Excel, PowerPoint, email, and web-based tools.

Preferred Qualifications

Experience developing regulated medical device products.

Experience working with automated or robotic electro-mechanical systems.

Experience supporting products from concept/design through manufacturing and commercialization.

Strong understanding of engineering documentation and design processes.

Education

Bachelor’s degree in Engineering, Mechanical, Biomedical, Mechatronics, Electromechanical Engineering, or a related technical discipline.

 


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About Siri Infosolutions

Sourced by ZipRecruiter

Our team of experts first gather each and every requirement of yours. Our research and development team then sit around those requirements and come up with a plan. Our implementation team then executes that plan for optimal results. After that our support team remains in constant touch with you during and after the entire process.

Industry

It services

Company size

201 - 500 Employees

Headquarters location

Edison, NJ, US

Year founded

2005