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Project Engineer Medical Device Jobs (NOW HIRING)

Intertek

Project Engineer, Medical Safety

Duluth, GA · On-site

Project Engineer-Medical Safety - Duluth, Georgia Intertek, a leading provider of quality and ... This is a fantastic opportunity to grow a versatile career in Medical device testing and ...

Mizuho OSI

Systems Engineer, Medical Device

Union City, CA · On-site

$82K - $150K/yr

... Systems Engineer you will be part of a small, agile team; responsible for medical device ... Grit to drive challenging projects to completion in a fast-pace environment. * Enjoy working in a ...

Actalent

Project Engineer (Contract)

Noblesville, IN

$48.08 - $55.29/hr

Project Engineer We are seeking a highly motivated Project Engineer to support a large-scale ... Ensure project activities meet applicable medical device regulations, quality standards, and ...

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All JobsProject Engineer Medical Device Jobs

Project Engineer Medical Device information

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$45K

$90.6K

$136K

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

As of Jul 22, 2026, the average yearly pay for project engineer medical device in the United States is $90,644.00, according to ZipRecruiter salary data. Most workers in this role earn between $74,000.00 and $103,500.00 per year, depending on experience, location, and employer.

What does a Project Engineer do in the medical device industry?

A Project Engineer in the medical device industry is responsible for planning, coordinating, and managing projects related to the development and manufacturing of medical devices. They oversee project timelines, budgets, and resources, ensuring that all technical and regulatory requirements are met. Their work involves collaborating with cross-functional teams, such as design, quality assurance, and regulatory affairs, to bring safe and effective medical devices to market. Project Engineers also help resolve technical challenges and ensure products comply with industry standards and government regulations.

How does a Project Engineer in the medical device industry typically collaborate with cross-functional teams during product development?

As a Project Engineer in the medical device field, you’ll work closely with cross-functional teams such as R&D, quality assurance, regulatory affairs, and manufacturing. Collaboration involves coordinating project timelines, ensuring design requirements are met, and facilitating communication between departments to address technical challenges and regulatory compliance. Regular meetings and clear documentation are essential to keep all stakeholders aligned, and you may often serve as a bridge between engineering and non-engineering teams. This collaborative environment fosters innovation and helps ensure the successful and timely launch of safe, effective medical devices.

What is the difference between Project Engineer Medical Device vs Quality Engineer Medical Device?

AspectProject Engineer Medical DeviceQuality Engineer Medical Device
Required CredentialsBachelor's in Engineering, certifications like PMP beneficialBachelor's in Engineering or Science, certifications like CQE preferred
Work EnvironmentDesign, development, and project management teams in manufacturing or R&DQuality assurance, compliance, and inspection teams in manufacturing
Employer & Industry UsageMedical device companies focusing on product development and project executionMedical device companies ensuring product quality and regulatory compliance
Common Search & Comparison IntentUnderstanding project management roles in medical device industryUnderstanding quality assurance roles in medical device industry

The Project Engineer Medical Device focuses on managing product development projects, coordinating teams, and ensuring timely delivery. In contrast, the Quality Engineer Medical Device concentrates on maintaining product quality, compliance with regulations, and conducting inspections. Both roles are essential in medical device companies but serve different functions within the product lifecycle.

What are the key skills and qualifications needed to thrive as a Project Engineer in the medical device industry, and why are they important?

To excel as a Project Engineer in medical devices, you need a solid background in engineering (typically a degree in biomedical, mechanical, or electrical engineering), experience with product development, and knowledge of regulatory standards like FDA and ISO 13485. Familiarity with CAD software, project management tools, and validation protocols is highly valuable, along with certifications such as PMP or Six Sigma. Strong problem-solving abilities, collaboration, and effective communication are essential soft skills for leading cross-functional teams and resolving technical challenges. These skills and qualifications ensure safe, compliant, and innovative device development that meets patient and market needs.
More about Project Engineer Medical Device jobs
What cities are hiring for Project Engineer Medical Device jobs? Cities with the most Project Engineer Medical Device job openings:
What states have the most Project Engineer Medical Device jobs? States with the most job openings for Project Engineer Medical Device jobs include:
What job categories do people searching Project Engineer Medical Device jobs look for? The top searched job categories for Project Engineer Medical Device jobs are:
Project Engineer Medical Device jobs near you
Infographic showing various Project Engineer Medical Device job openings in the United States as of July 2026, with employment types broken down into 77% Full Time, 14% Part Time, and 9% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $90,644 per year, or $43.6 per hour.
Validation Engineer (Medical Device)

Validation Engineer (Medical Device)

Scalable Systems

San Diego, CA • On-site

Other

Posted 26 days ago

Job description

Scalable Systems is a USA based Big Data, Analytics and Digital Transformation company focused on vertical specific innovative solutions. By providing next generation technology solutions and services, we help organizations to identify risks & opportunities, achieve operational excellence and to gain an innovative edge.

Job Role – Validation Engineer (Medical Device)
Location – San Diego, CA (Day 1 Onsite)
Role Descriptions: Must Have Technical/Functional Skills

Must-Have Skills

· Strong expertise in V&V for medical devices

· Hands-on experience in:

o Protocol writing (IQ, OQ, PQ, CSV, system validation)

o Validation execution and reporting

· Deep understanding of:

o FDA regulations (21 CFR Part 820)

o ISO 13485 standards

o Risk management (ISO 14971)

· Experience in regulated environments with minimal supervision

· Ability to independently manage multiple protocols simultaneously

Preferred Skills

· Experience with complex medical systems (e.g., imaging systems, surgical systems, or similar platforms like Elita)

· Exposure to software validation / computerized system validation (CSV)

· Prior experience in large-scale validation programs (100+ protocols) · Strong documentation and audit readiness experience · Familiarity with tools like: o TrackWise / Veeva / ETQ (or similar QMS systems) Experience Requirement · 8–12+ years in V&V within the medical device industry · Proven experience working as a Subject Matter Expert (SME) · Prior experience working in onsite client environments in the US is a strong plus · Expat profiles are acceptable Candidate Profile · Self-driven and capable of working independently with minimal guidance · Strong ownership mindset with execution focus · Excellent communication and stakeholder management skills · Comfortable working under tight timelines and immediate onboarding expectations

Roles & Responsibilities

Role Overview:

We are looking for experienced Validation & Verification (V&V) experts to support protocol development and execution for the Elita system. The role requires independent ownership of end-to-end V&V activities with minimal onboarding or training.

The candidate will contribute toward executing approximately 150–170 validation protocols within a defined timeline

Key Responsibilities:

· Independently author, review, and execute V&V protocols (IQ/OQ/PQ, system validation, software validation, etc.)

· Ensure all validation activities comply with regulatory standards (FDA, ISO 13485, 21 CFR Part 820)

· Drive end-to-end protocol lifecycle, including:

o Protocol authoring

o Test execution

o Documentation and reporting

o Defect tracking and resolution

· Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Regulatory)

· Provide SME-level inputs for validation strategy and risk-based validation approaches

· Support audit readiness and documentation for regulatory inspections

· Work in a high-paced environment with immediate delivery expectations

Generic Managerial Skills, If any

1. Leadership

2. Communication Skills

3. Stakeholder Management

4. Decision Making

5. Problem Solving

6. Mentoring & Coaching

7. Conflict Resolution

8. Strategic Thinking

9. Time & Priority Management

10. Adaptability & Flexibility

Desirable Skills:

Keyword:

Skills: ISO 13485~EIS : Medical Device & Regulations Experience Required: 10 & Above

Scalable Systems is an Equal Opportunity-Affirmative Action Employer - Minority / Female / Disability / Veteran / Gender Identity / Sexual Orientation

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