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Medical Device Design Jobs (NOW HIRING)

Medical Device Product Development * Lead projects and evaluate design changes related to existing products to maintain business continuity. * Develop and evaluate medical device designs which meet ...

Execute medical device design history file activities to be compliant with applicable regulations * Conduct the development and evaluation of medical device designs which meet defined product ...

Medical Device Product Development * Lead projects and evaluate design changes related to existing products to maintain business continuity. * Develop and evaluate medical device designs which meet ...

Medical Device Engineer

Aurora, CO ยท Hybrid

$57.69/hr

Design, evaluate, and support electrical systems used in medical devices. * Plan, execute, and ... Support compliance efforts related to EU Medical Device Regulation (EU MDR 2017/745). * Develop ...

Execute medical device design history file activities to be compliant with applicable regulations * Conduct the development and evaluation of medical device designs which meet defined product ...

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Medical Device Design information

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How much do medical device design jobs pay per hour?

As of Aug 11, 2026, the average hourly pay for medical device design in the United States is $49.84, according to ZipRecruiter salary data. Most workers in this role earn between $35.10 and $59.62 per hour, depending on experience, location, and employer.

What is a medical device design?

A Medical Device Design job involves creating, developing, and improving medical devices to ensure they are safe, effective, and user-friendly. Professionals in this field work with engineers, regulatory specialists, and healthcare professionals to meet industry standards and patient needs. They use computer-aided design (CAD) software, prototyping, and testing methodologies to refine devices before production. The role requires knowledge of biomechanics, materials science, and regulatory guidelines such as FDA and ISO standards.

What are some typical challenges faced in a medical device design role?

Medical Device Design professionals often encounter challenges such as balancing innovative design with stringent regulatory requirements and ensuring devices are both effective and safe for patient use. Navigating complex approval processes, collaborating with clinicians for feedback, and keeping up with rapidly evolving technologies can also be demanding. However, these challenges make the role dynamic and rewarding, as designers play a direct role in improving patient outcomes. Team-based problem solving and ongoing learning are key parts of the job, and successfully overcoming challenges can lead to career growth and leadership opportunities within the medical device industry.

What are the key skills and qualifications needed to thrive in medical device design, and why are they important?

Success in Medical Device Design requires a solid understanding of biomedical engineering, materials science, and human anatomy, often supported by a relevant engineering degree and experience in product development. Familiarity with CAD software, rapid prototyping tools, and regulatory standards such as FDA or ISO 13485 certification is common in the field. Strong problem-solving abilities, teamwork, and effective communication help professionals excel in multidisciplinary design teams. These competencies are crucial for creating safe, innovative medical devices that meet strict quality and regulatory requirements.

More about Medical Device Design jobs
What cities are hiring for Medical Device Design jobs? Cities with the most Medical Device Design job openings:
What are the most commonly searched types of Medical Device Design jobs? The most popular types of Medical Device Design jobs are:
What states have the most Medical Device Design jobs? States with the most job openings for Medical Device Design jobs include:
What job categories do people searching Medical Device Design jobs look for? The top searched job categories for Medical Device Design jobs are:
Infographic showing various Medical Device Design 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 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $103,662 per year, or $49.8 per hour.

Medical Device Design Control Engineer

Prophecy Technologies

Indianapolis, IN โ€ข On-site

$123K - $148K/yr

Full-time

Posted 15 days ago


Job description

Role Overview:
This role involves supporting Design History File (DHF) activities and comprehensive risk management for medical device development projects. The engineer will be responsible for reviewing, updating, and maintaining critical documentation such as FMEAs, PHAs, Product Characterization, and Product Specifications, ensuring compliance with regulatory and quality standards throughout the product lifecycle.
Key Responsibilities:
  • Support Design History File (DHF) activities for medical device development projects.
  • Review, update, and maintain Global dFMEA documentation ensuring risks are adequately identified, analyzed, and mitigated.
  • Review, update, and maintain Global uFMEA documentation based on product use scenarios and user-related risks.
  • Develop and update Preliminary Hazard Analysis (PHA) documentation in accordance with risk management procedures.
  • Support creation and maintenance of product risk management files throughout the development lifecycle.
  • Prepare, review, and update Product Characterization documents to define product performance and design intent.
  • Create and maintain Product Specification Documents (PSD) ensuring alignment with design requirements and customer needs.
  • Develop and update Critical-to-Quality (CTQ) documents and establish measurable quality requirements.
  • Support development and maintenance of Design Input, Design Output, Verification, and Validation documentation.
  • Ensure traceability between user needs, design inputs, risk controls, verification activities, and design outputs.
  • Collaborate with Design, Quality, Regulatory, Manufacturing, and Project Management teams to support product development deliverables.
  • Participate in design reviews and provide technical input on risk management and DHF compliance.
  • Support engineering change assessments and associated documentation updates.
  • Review engineering documents for completeness, accuracy, and compliance with quality system requirements.
  • Identify gaps in documentation and recommend corrective actions.
  • Support audits, inspections, and compliance activities related to design control and risk management documentation.
  • Contribute to continuous improvement initiatives for product development and design control processes.
  • Ensure all deliverables comply with applicable regulatory, quality, and Zimmer Biomet procedures and standards.
  • Communicate (written and verbal) direction and project plans with appropriate personnel from other departments.

Required Skills:
  • Ability to establish document traceability between User Needs, Design Inputs, Design Outputs, Risk Management, Verification, and Validation records within Cockpit Cognition.
  • Experience supporting DHF gap assessments, document linking, metadata management, and compliance reviews.
  • Familiarity with digital DHF structure, document hierarchy, and traceability matrix development.
  • Knowledge of DHF remediation projects and legacy design documentation migration into Cockpit Cognition.

Qualifications:
  • Experience: N/A