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Medical Device Product Engineer Jobs (NOW HIRING)

Alexion Pharmaceuticals

$97K - $146K/yr

Understanding of medical device product development risk management methodologies. Possesses ... Master's, or PhD Degree in Engineering(Mechanical, Biomedical, Chemical or Materials Science and ...

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All JobsMedical Device Product Engineer Jobs

Medical Device Product Engineer information

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$53K

$144.1K

$205K

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

As of Jun 14, 2026, the average yearly pay for medical device product engineer in the United States is $144,072.00, according to ZipRecruiter salary data. Most workers in this role earn between $88,000.00 and $205,000.00 per year, depending on experience, location, and employer.

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

AspectMedical Device Product EngineerMechanical Engineer
Required CredentialsBachelor's in engineering, certifications like RAPS or regulatory trainingBachelor's in mechanical engineering, professional engineer (PE) license often preferred
Work EnvironmentMedical device companies, regulated environments, cross-functional teamsManufacturing, design firms, various industries including automotive and aerospace
Industry UsageHealthcare, medical device manufacturing, FDA complianceMultiple industries, focus on mechanical systems and design

Medical Device Product Engineers focus on designing, developing, and ensuring compliance of medical devices, often working within regulated healthcare environments. Mechanical Engineers have a broader scope, working on mechanical systems across various industries. While both roles require engineering degrees, Medical Device Product Engineers often need knowledge of FDA regulations and medical standards, making their roles more specialized within healthcare.

What are the key skills and qualifications needed to thrive as a Medical Device Product Engineer, and why are they important?

To thrive as a Medical Device Product Engineer, you need a solid background in engineering (typically biomedical, mechanical, or electrical), knowledge of medical device regulations, and a relevant degree. Familiarity with CAD software, prototyping tools, and regulatory standards like ISO 13485 or FDA requirements is essential. Strong problem-solving skills, teamwork, and attention to detail help you excel in cross-functional environments and ensure product safety. These competencies ensure the development of innovative, compliant, and reliable medical devices that improve patient outcomes and meet industry standards.

What are typical cross-functional collaborations for a Medical Device Product Engineer, and how do they impact project success?

Medical Device Product Engineers regularly collaborate with teams such as Regulatory Affairs, Quality Assurance, Manufacturing, and Clinical Affairs. These collaborations are essential for ensuring that products meet regulatory standards, are manufacturable at scale, and address end-user needs. Effective teamwork helps streamline product development, minimize costly redesigns, and accelerate time-to-market. Building strong communication skills and understanding the priorities of other departments can significantly enhance both project outcomes and your personal growth in the role.

What does a Medical Device Product Engineer do?

A Medical Device Product Engineer is responsible for designing, developing, and improving medical devices used in healthcare settings. They work closely with cross-functional teams to ensure products meet regulatory standards, safety requirements, and user needs. Their duties include creating prototypes, conducting tests, analyzing data, and supporting the manufacturing process. Additionally, they often participate in quality assurance and risk assessment to ensure the final product is safe and effective for patients.
More about Medical Device Product Engineer jobs
What cities are hiring for Medical Device Product Engineer jobs? Cities with the most Medical Device Product Engineer job openings:
What states have the most Medical Device Product Engineer jobs? States with the most job openings for Medical Device Product Engineer jobs include:
What job categories do people searching Medical Device Product Engineer jobs look for? The top searched job categories for Medical Device Product Engineer jobs are:
Medical Device Product Engineer jobs near you
Infographic showing various Medical Device Product Engineer job openings in the United States as of June 2026, with employment types broken down into 1% Locum Tenens, 95% Full Time, 2% Part Time, 1% Temporary, and 1% Contract. Highlights an 87% Physical, 5% Hybrid, and 8% Remote job distribution, with an average salary of $144,072 per year, or $69.3 per hour.
Sr. Design Assurance Engineer - Medical Device

Sr. Design Assurance Engineer - Medical Device

Resolution Medical

Fridley, MN • On-site

$120K - $150K/yr

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 9 days ago

Job description

Job Type
Full-time
Description
Job Summary:
The Senior Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization working with cross-functional development teams to establish and maintain the design control deliverables, risk management activities, and DHF compliance to ensure delivery of the highest quality product to the customer.
Essential Functions:
  • Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects and leading on-time completion of protocols, reports and assigned project deliverables
  • Accountable for Design Verification and Validation planning and /or, including active cross-functional root-cause analysis investigation & resolution activities
  • Lead Risk Management activities from product Concept through Commercialization
  • Support design test and inspection method development, and lead method validation activities
  • Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps
  • Support and ensure internal & external audit responses and on-time product re-certifications
  • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, and product requirements
  • Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Provide support for biocompatibility and sterilization qualifications
  • Develop and lead other team members and provide work direction as required
  • May have 2-3 technicians assigned for inspection, testing and project support
  • Performs other functions as required

Requirements
Education, Experience, and Required Skills:
  • BS Industrial Engineering, Engineering or Business Degree
  • 8-15 years of medical device experience in Quality Operations, or equivalent experience
  • 1-3 years of direct or indirect supervisory experience preferred
  • Comprehensive understanding of FDA regulations, ISO 13485, ISO 14971

Preferred Skills:
  • Statistical and data analysis
  • Supervisory, Solid Management and Strong Leadership experience

Physical Requirements:
  • Prolonged periods sitting at a desk and working on a computer
  • Must be able to lift 25 pounds at times
  • Must have manual dexterity
  • Must have excellent hand-eye coordination
  • Must wear gown, gloves, and ear protection if applicable

Summary of Benefits
  • Group health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan), and Flexible Spending Accounts.
  • Company-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Kavira (requires participation in medical plan).
  • Voluntary, employee-paid benefits: Employee Supplemental Life & AD&D, Spouse and Dependent Life & AD&D, Short Term Disability (STD), Accident, Critical Illness, and Hospital Indemnity, Employee Assistance Program.
  • Flexible Time Off Program
  • Paid Parental Leave
  • Paid Holidays
  • Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.

Compensation
  • The typical base pay range for this role is between $120,000-150,000/year. Compensation will vary based on individual job-related knowledge, skills, expertise, and experience. This position is eligible for a discretionary annual incentive program driven by organization and individual performance.
  • 401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.

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