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Medical Device Manufacturing Engineer Jobs (NOW HIRING)

Manufacturing Engineer

New Brunswick, NJ · On-site

$75K - $97K/yr

Manufacturing Engineer | Onsite | New Brunswick, NJ We''''re hiring a Manufacturing Engineer to join a leading pharmaceutical/medical device manufacturing team in New Brunswick. This is an excellent ...

Manufacturing Engineer

Madison, WI · On-site

$73K - $94K/yr

Manufacturing Engineer Location: Onsite - Madison, WI Pay Rate: 48-54/hr. (W2) Job Summary The ... Prior experience in a medical device manufacturing or technical support role is highly desirable.

Manufacturing Engineer I

Trumbull, CT · On-site

$71K - $92K/yr

The Manufacturing Engineer I will primarily contribute to sustaining activities, as well as ... Introductory knowledge of medical device manufacturing processes. * Strong computer skills with the ...

Manufacturing Engineer I

Trumbull, CT · On-site

$71K - $92K/yr

The Manufacturing Engineer I will primarily contribute to sustaining activities, as well as ... Design and development of efficient manufacturing processes for medical device products, with a ...

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Medical Device Manufacturing Engineer information

See salary details

$47.5K

$85.6K

$120K

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

As of Aug 13, 2026, the average yearly pay for medical device manufacturing engineer in the United States is $85,613.00, according to ZipRecruiter salary data. Most workers in this role earn between $73,000.00 and $94,000.00 per year, depending on experience, location, and employer.

What is the difference between Medical Device Manufacturing Engineer vs Quality Assurance Engineer?

AspectMedical Device Manufacturing EngineerQuality Assurance Engineer
CredentialsBachelor's in engineering or related field; certifications like ASQ CQE beneficialBachelor's in engineering, quality assurance, or related; certifications like ASQ CQE or CQA common
Work EnvironmentManufacturing plants, production lines, R&D labsQuality labs, manufacturing sites, regulatory agencies
Industry UsageDesign, develop, and optimize manufacturing processesEnsure product quality, compliance, and process improvements

While both roles work within the medical device industry and require similar credentials, the Medical Device Manufacturing Engineer focuses on manufacturing processes and product development, whereas the Quality Assurance Engineer emphasizes maintaining quality standards and regulatory compliance.

What are the key skills and qualifications needed to thrive as a medical device manufacturing engineer?

To excel as a Medical Device Manufacturing Engineer, you need a solid background in engineering principles, manufacturing processes, and regulatory compliance, typically supported by a degree in biomedical, mechanical, or industrial engineering. Familiarity with CAD software, Six Sigma/Lean methodologies, and knowledge of FDA or ISO 13485 standards is essential. Strong problem-solving, teamwork, and communication skills help manage cross-functional projects and ensure product quality. These competencies are crucial for developing safe, effective devices in a highly regulated industry where precision and compliance are paramount.

What are some common challenges faced by medical device manufacturing engineers during product development?

Medical Device Manufacturing Engineers often encounter challenges in balancing strict regulatory compliance with efficient production processes. Adapting to frequent design changes, ensuring high product quality, and validating manufacturing processes are crucial tasks. Additionally, they collaborate closely with cross-functional teams—including quality assurance, R&D, and supply chain—to troubleshoot production issues and implement improvements. Addressing these challenges requires strong problem-solving skills and a keen attention to detail.

What does a medical device manufacturing engineer do?

A Medical Device Manufacturing Engineer is responsible for designing, developing, and optimizing manufacturing processes for medical devices. They ensure that products are produced efficiently, safely, and in compliance with regulatory standards such as FDA or ISO guidelines. Their work involves collaborating with design teams, troubleshooting production issues, implementing quality control procedures, and continuously improving manufacturing methods to enhance product quality. Ultimately, they play a key role in bringing safe and effective medical devices to market.
More about Medical Device Manufacturing Engineer jobs

What cities are hiring for Medical Device Manufacturing Engineer jobs?

Cities with the most Medical Device Manufacturing Engineer job openings:

What states have the most Medical Device Manufacturing Engineer jobs?

States with the most job openings for Medical Device Manufacturing Engineer jobs include:

Infographic showing various Medical Device Manufacturing Engineer job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $85,613 per year, or $41.2 per hour.

Engineer II - Med Device / Manufacturing Engineer

FLEX Vascular

Plymouth, MN • On-site

$77K - $99K/yr

Full-time

Posted yesterday

New


Job description

ENGINEER II - Medical Device Product Development & Manufacturing Engineering (Vascular Access Devices)

Position Summary

The Engineer II role supports the design, development, validation, and sustaining engineering of vascular access devices and their associated manufacturing processes. Working within established procedures and under general supervision, the Engineer role II independently executes defined engineering projects including test method development, process and equipment qualification, fixture design, and technical investigations and documents the results in compliance with the Quality Management System and applicable regulatory requirements. The role escalates novel or ambiguous technical problems to senior engineering staff and contributes to cross-functional design and process review activities.

Essential Duties and Responsibilities

Design and Development Support

Provide project support including device and component testing, protocol authoring, documentation of test results, data analysis, and preparation of technical reports in accordance with design control procedures.

Contribute to Design History File (DHF) and Device Master Record (DMR) content for assigned projects.

Design, model, and fabricate test and manufacturing fixtures, including CAD modeling and additive manufacturing (3D printing) of prototypes.

Participate actively in design and process reviews.

Test Method and Process Validation

Design and execute test method validations (TMV), measurement systems analysis (MSA) including Gage R&R studies, and designs of experiments (DOE); analyze and report results.

Support line validation and qualification activities including IQ, OQ, and PQ authoring protocols and reports and executing testing.

Develop and document statistical rationale for sampling plans, sample sizes, acceptance criteria, and confidence/reliability targets.

Risk Management and Quality Systems

Participate in risk management activities including PFMEA, DFMEA, and use-related FMEA (uFMEA), and contribute to the risk management file in accordance with ISO 14971.

Perform process mapping and support process characterization and improvement initiatives.

Author and assess engineering change orders (ECOs) and change control records, including impact and validation assessments.

Provide technical investigation support for nonconformances, CAPAs, and complaint investigations. Complaint reportability and regulatory decisions remain the responsibility of Quality Assurance and Regulatory Affairs.

Manufacturing and Supplier Support

Interact with suppliers and vendors to facilitate new manufacturing processes or changes to existing processes, including technical support during process transfers.

Perform product and component inspections in compliance with company policies and procedures.

Support shipping and receiving of commercial product and components as required.

Qualifications

Required

Bachelor's degree in Mechanical, Biomedical, Manufacturing, or a related engineering discipline.

2-5 years of engineering experience, preferably in medical device or another FDA-regulated manufacturing environment.

Working knowledge of design controls and validation principles (IQ/OQ/PQ, TMV, MSA).

Demonstrated ability to author clear technical protocols and reports suitable for a regulated document system.

Proficiency with 3D CAD software (e.g., SolidWorks) and standard office productivity tools.

Preferred

Familiarity with medical device standards and guidance documents.

Experience with statistical software (e.g., Minitab, JMP) and applied statistical methods.

Experience with GD&T and inspection method development.

Experience with catheter, guidewire, or other vascular access device manufacturing processes.

Experience working in an ISO Class 7/8 controlled environment.