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Medical Device Product Development Engineer Jobs in Arizona

Principal R&D Engineer

Tempe, AZ · On-site

$55 - $65/hr

Principal R&D Engineer Client: Medical Device Manufacturing Company Duration: 8.5 Months ... Collaborate with cross-functional teams to support product development, manufacturing readiness ...

Designs, validates and brings new products to market. Specifies precise new product functional ... Vascular device engineering preferred Technical ability to develop and optimize designs for medical ...

CPR is seeking a Product Development Engineer (PDE) to join our team. The PDE section is ... Hired applicants may be eligible for benefits, including but not limited to, medical, dental ...

Product Development Engineer

Tucson, AZ · On-site

$107.50 - $204.50/hr

CPR is seeking a Product Development Engineer (PDE) to join our team. The PDE section is ... Hired applicants may be eligible for benefits, including but not limited to: * medical * dental ...

CPR is seeking a Product Development Engineer (PDE) to join our team. The PDE section is ... Hired applicants may be eligible for benefits, including but not limited to, medical, dental ...

CPR is seeking a Product Development Engineer (PDE) to join our team. The PDE section is ... Hired applicants may be eligible for benefits, including but not limited to, medical, dental ...

The Product Development Engineer, is responsible for designing, developing, and improving stretch film products used in packaging and load stabilization applications. This role focuses on polymer ...

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BEPC is seeking a detail-oriented Medical Device Assembler to support the production and assembly ... technology, engineering, manufacturing, and project management. At BEPC, we are driven by ...

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Medical Device Product Development Engineer information

See Arizona salary details

$36.8K

$81.9K

$123.5K

How much do medical device product development engineer jobs pay per year?

As of Sep 7, 2026, the average yearly pay for medical device product development engineer in Arizona is $81,898.00, according to ZipRecruiter salary data. Most workers in this role earn between $67,100.00 and $93,200.00 per year, depending on experience, location, and employer.

What does a medical device product development engineer do?

A Medical Device Product Development Engineer is responsible for designing, developing, and testing medical devices to ensure they are safe, effective, and compliant with regulatory standards. They work closely with cross-functional teams, including quality assurance, regulatory affairs, and manufacturing, to take products from concept through to production. Their tasks often include prototyping, risk assessment, documentation, and troubleshooting any issues that arise during the development process. Additionally, they must stay updated on industry standards and regulations to ensure that products meet all necessary requirements for market approval.

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

To thrive as a Medical Device Product Development Engineer, you need a strong background in biomedical, mechanical, or electrical engineering, along with knowledge of FDA regulations and product development processes. Familiarity with CAD software, prototyping tools, risk management systems, and regulatory standards such as ISO 13485 is typically required. Creativity, problem-solving, and effective teamwork are essential soft skills that drive innovation and ensure project success. These skills and qualifications are crucial for developing safe, effective medical devices that meet strict regulatory requirements and address real-world healthcare needs.

What are some common challenges medical device product development engineers face when working on new product designs?

Medical Device Product Development Engineers often navigate strict regulatory requirements and rigorous testing protocols to ensure product safety and compliance. Balancing innovative design with manufacturability and cost constraints can be challenging, as can coordinating input from cross-functional teams such as clinical, regulatory, and manufacturing. Additionally, managing project timelines while accommodating iterative design changes based on feedback or testing results requires strong organizational and communication skills.

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

AspectMedical Device Product Development EngineerQuality Assurance Engineer
CredentialsEngineering degree, certifications like PMP or Six Sigma often preferredEngineering or science degree, certifications like CQE or ISO auditor training
Work EnvironmentDesign labs, R&D departments, cross-functional teamsManufacturing facilities, quality control labs, compliance departments
Industry UsageInvolved in designing and developing new medical devicesEnsures products meet quality standards and regulatory requirements

While both roles are essential in the medical device industry, the Medical Device Product Development Engineer focuses on creating and improving devices, whereas the Quality Assurance Engineer ensures these devices meet safety and quality standards. Understanding these differences helps in choosing the right career path or job search focus.

What are popular job titles related to Medical Device Product Development Engineer jobs in Arizona?

For Medical Device Product Development Engineer jobs in Arizona, the most frequently searched job titles are:

What job categories do people searching Medical Device Product Development Engineer jobs in Arizona look for?

The top searched job categories for Medical Device Product Development Engineer jobs in Arizona are:

What cities in Arizona are hiring for Medical Device Product Development Engineer jobs?

Cities in Arizona with the most Medical Device Product Development Engineer job openings:

Infographic showing various Medical Device Product Development Engineer job openings in Arizona as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 14% Part Time, 2% Temporary, and 6% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $81,898 per year, or $39.4 per hour.

Product Risk Management Engineer

W. L. Gore & Associates, Inc.

Flagstaff, AZ • On-site

Full-time

Posted 9 days ago


Key responsibilities

  • Own product line risk management files and maintain documentation in accordance with ISO 14971 and regulatory requirements.

  • Support technical investigations and problem-solving efforts to address product or process issues and improve product performance.

  • Partner with development teams to ensure quality management system documentation and assess risks from design and manufacturing changes.


W. L. Gore & Associates rating

8.9

Company rating: 8.9 out of 10

Based on 80 frontline employees who took The Breakroom Quiz

8th of 546 rated manufacturers


Job description

Product Risk Management Engineer
Req Id: 2110
State/Province: Arizona
Business: Gore Medical Products
Category: Engineering, Scientists & Technicians
Sub-Category: Engineering
Work Arrangement: Hybrid, On-site
Posting Start Date: 8/27/26
Posting End Date: 9/11/26
About the Role
We are looking for experienced Product Risk Management Engineer (PRME) to join our engineering team supporting commercial manufacturing and new product development. In this role, you will lead and facilitate risk assessments, guide risk-based product and manufacturing process development, and utilize quality system data to make risk-based decisions to ensure product safety.
The PRME contributes to the development and maintenance of compliant risk management systems, procedures and practices and is responsible for the Risk Management File portion of the product Design History File.
This position could be located at our facility in Flagstaff, Arizona or Phoenix, Arizona.
Responsibilities
  • Own product line risk management files; partner with product teams to create, manage, and maintain product risk management files and associated documentation in accordance with the requirements of ISO 14971 and global regulatory requirements
  • Support technical investigations and problem-solving efforts to address product or process issues, resolve technical uncertainties, and improve product performance
  • Partner with other engineers in a wide range of process projects throughout the development cycles: scale-up, validation, and improvement (improved safety, cost, quality, capability, and capacity)
  • Partner with new product development teams to ensure appropriateness and adequacy of quality management system documentation, facilitate design and development planning and execution
  • Utilize Risk Management File and Design History File documents to assess risk resulting from design and manufacturing process changes, manufacturing events and post-market surveillance
  • Perform periodic review of Risk Management File documents to ensure the files remain reflective of data/trending signals and ongoing activities
  • Partner with subject matter experts in the development, maintenance and promotion of risk management processes for medical devices, including management and maintenance of global policies and procedures
  • Help to execute divisional changes to Risk Management Files due to changes in standards, regulations, or industry best practices
  • Ensure consistency of Risk Management Files across product line
  • Practice equitable and inclusive behaviors with other Associates to achieve outstanding results

Required Qualifications
  • Bachelor's Degree in Engineering, Science or Technical Field
  • Minimum 5 years' experience with product risk management processes
  • Experience applying structured problem-solving approach (such as 8D, 8-Step, DMAIC or PDCA) that drives root cause analysis using 5-Why, Why Trees, and Fishbone analysis
  • Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Part 803 and 820, ISO13485, ISO14971, EN 62366-1, and European Medical Device Regulations
  • Knowledge of product risk management (risk identification, analysis, and mitigation methods), medical device product design and manufacturing processes
  • Ability to apply engineering fundamentals and statistical analysis to product quality support, optimization, and troubleshooting activities
  • Ability to work effectively in team situations, building an inclusive environment, mentoring others as well as the ability to independently prioritize, initiate and drive projects from development to completion within agreed upon timelines.
  • Ability to identify critical issues and failure modes, creating a framework of action to address these issues and assess root cause including effective risk-based decision making
  • Strong verbal, presentation, and written communication skills
  • Ability to travel up to 10%

Desired Qualifications
  • Product risk management process experience in the medical device/pharmaceutical industry
  • Experience with design controls, risk management, and requirements management within new product development (NPD) environments
  • Strong analytical and organizational skills, flexibility, and attention to detail

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