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Medical Device Software Jobs (NOW HIRING)

Diality

Director, Software Engineering

Irvine, CA · Hybrid

$223K - $260K/yr

Description Company & Job Overview Diality is a medical device company focused on developing ... The Director of Software Engineering reports to Director of Product Development and leads Diality ...

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Diality Inc

Director, Software Engineering

Irvine, CA · On-site

$223K - $260K/yr

Company & Job Overview Diality is a medical device company focused on developing solutions to ... The Director of Software Engineering reports to Director of Product Development and leads Diality ...

New

Abbott

Software Quality Engineer

Alameda, CA · On-site

$80 - $85/hr

Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software. Coordinate activities with other engineering ...

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How much do medical device software jobs pay per hour?

As of Jul 21, 2026, the average hourly pay for medical device software 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 are the key skills and qualifications needed to thrive as a Medical Device Software Engineer, and why are they important?

To thrive as a Medical Device Software Engineer, you need strong programming abilities (often in C/C++ or Python), a solid understanding of software development life cycles, and familiarity with medical device regulations, typically backed by a degree in computer science, engineering, or a related field. Experience with development tools, embedded systems, and compliance standards like IEC 62304 or FDA requirements is highly valued. Attention to detail, problem-solving, and effective teamwork are essential soft skills in this role. These competencies ensure the creation of reliable, safe, and regulatory-compliant software critical for patient health and device performance.

What is the difference between Medical Device Software vs Medical Device Quality Assurance Specialist?

AspectMedical Device SoftwareMedical Device Quality Assurance Specialist
Required CredentialsSoftware development certifications, engineering degrees, FDA regulations knowledgeQuality assurance certifications (e.g., CQE), regulatory compliance training
Work EnvironmentSoftware development teams, R&D labs, regulatory agenciesManufacturing facilities, quality assurance labs, regulatory bodies
Employer & Industry UsageMedical device manufacturers, software firms in healthcareMedical device manufacturers, healthcare companies, regulatory agencies
Common Search & ComparisonFocuses on software development and complianceFocuses on quality processes and regulatory adherence

Medical Device Software professionals develop and maintain software used in medical devices, ensuring functionality and compliance. Medical Device Quality Assurance Specialists focus on testing, validation, and ensuring products meet quality standards. Both roles are essential in the medical device industry but differ in their core responsibilities and skill sets.

What are some common challenges faced by professionals working in Medical Device Software development?

Professionals in Medical Device Software development often navigate complex regulatory requirements, such as FDA or ISO standards, which can impact project timelines and processes. Collaborating closely with cross-functional teams—including hardware engineers, clinicians, and quality assurance specialists—is essential to ensure safety and compliance. Additionally, balancing innovation with rigorous documentation and validation can be challenging, as even minor software changes may require extensive testing and approval. Staying updated with evolving cybersecurity standards is also a key part of the role.

What is medical device software?

Medical device software is specialized software designed to be used for medical purposes, such as diagnosing, preventing, monitoring, or treating health conditions. It can be embedded within a medical device (like a pacemaker) or function as standalone software (such as mobile health apps). This software must comply with strict regulatory standards to ensure safety and effectiveness, as it directly impacts patient health and safety. Developers of medical device software must follow guidelines from authorities like the FDA or EU MDR, depending on the market. Regular updates, risk management, and comprehensive testing are also essential parts of its development process.
More about Medical Device Software jobs
What cities are hiring for Medical Device Software jobs? Cities with the most Medical Device Software job openings:
What states have the most Medical Device Software jobs? States with the most job openings for Medical Device Software jobs include:
What job categories do people searching Medical Device Software jobs look for? The top searched job categories for Medical Device Software jobs are:
Medical Device Software jobs near you
Infographic showing various Medical Device Software 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 $103,662 per year, or $49.8 per hour.
Senior Software Quality Engineer - Global Device Software Steward Support

Senior Software Quality Engineer - Global Device Software Steward Support

Boston Scientific

Maple Grove, MN • On-site

Full-time

This job post has expired today. Applications are no longer accepted.

Boston Scientific rating

8.5

Company rating: 8.5 out of 10

Based on 119 frontline employees who took The Breakroom Quiz

33rd of 528 rated manufacturers

Job description

Recruiter: Spencer Gregory Hale
Senior Software Quality Engineer - Global Device Software Steward Support
Travel amount: Up to 10%
Remote Eligible: Hybrid
Onsite Location(s): Hybrid in MN
About the role:
This Device Software Sub-Process Steward Support role teams with the Device Software Sub-Process Steward to help with leadership and oversight to the Device Software sub-process. The Device Software sub-process controls device software considered a finished medical device or used as a component, part, or accessory of a medical device developed, subcontracted, modified, or purchased. Quality System Stewards use the Best4 (Culture, Agility, Performance, Compliance) Strategy to enable our Quality Policy. Global Quality System Device Software sub-process maintain oversight of all processes in their assigned Sub-Process. Sub-Process Stewards work together to maintain their assigned Process(es) and ensure all responsibilities are fulfilled.
Your responsibilities will include:
  • Best Culture:

  • Sustain Device Software Community of Practice (CoP).

  • Provide subject matter expertise for the organization and collaborate with site/divisional experts.

  • Write applicable annual quality goals and objectives with input from sites, divisions, regions, and leadership to align with Best4 and organizational strategies. Support and update goals and objectives throughout the year.

  • Best Agility:

  • Monitor Device Software Sub-Process and implement process improvements based on performance feedback.

  • Drive value improvement projects (VIP) to support organizational goals.

  • Support acquisition integration as needed.

  • Increase Quality System simplicity, efficiency and predictability with standardization and lean practices.

  • Maintain and enhances internal and external relationships in support of the Global Quality System Process/Sub-Process.

  • Best Performance

  • Monitor and mitigate Quality System Process compliance risk where appropriate.

  • Lead or oversee quality projects of major magnitude and scope. Provide input to overall quality project portfolio and project priorities.

  • Determine if changes are reportable to notified bodies.

  • Initiative corporate preventive CAPAs and own or participate in corporate preventive CAPA teams.

  • Create, implement, and sustain measures and metrics to monitor Device Software Sub-Process health.

  • Provide metrics, data and analysis for management review.

  • Best Compliance:

  • Establish and maintain Global Quality System Device Software Sub-Process to ensure compliance with applicable quality and regulatory requirements.

  • Review of new Laws Regulations Standards and Guidance's (LRGS) and the implementation of new requirements into the BSC Quality System.

  • Communicate new and updated requirements.

  • Provide subject matter expertise and support for corporate and site internal and external audits. -

  • Review quarterly data per Quality System Process Compliance Assessment.

  • Support the audit non-conformance response strategies.

  • Identify Global Quality System Device Software Sub-Process training requirements.

  • Support corporate NCEP & CAPA Processes.

  • Assess reportability of substantial Quality System Changes.

  • Ensuring quality records are created, maintained and dispositioned.

Required Qualifications:
  • Bachelor's level degree in Science/Engineering/Computer Science/Software Engineering discipline and/or Minimum of 4 years of related experience in the Medical Device regulated industry.

  • Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, IEC 62304; ISO 14971; FDA Guidance - General Principles of Software Validation and Computer Software Assurance for Production and Quality System Software.

  • Must have good understanding of quality system requirements and how each quality system element connects.

  • Comfortable speaking and presenting to leadership

  • Strong written and verbal communication skills in English

  • Experience managing projects and project deliverables to completion

  • Comfortable working independently and as part of a cross-functional team

  • Ability to manage multiple priorities

  • Proficient in Microsoft Office

  • Works willingly and effectively with others in and across the organization to accomplish team goals with excellent interpersonal and networking skills.

  • Values people's opinions and encourages knowledge sharing. High level of energy, drive and enthusiasm

  • Knowledge of Software Engineering Principles and Software Development Life Cycle (SDLC)

  • Ability to work independently and collaborate with cross-functional teams to complete projects

  • Strong critical thinking and analytical skills: process and results-oriented

  • Detail oriented with strong organizational skills; ability to multi-task and prioritize competing responsibilities effectively

Preferred Qualifications:
  • Device Software Engineering Experience, including:

  • Device Software Development

  • Device Software Testing / Verification

  • Risk Management

  • Cybersecurity

  • Artificial Intelligence / Machine Learning

  • Agile Practices

  • Experience in supporting and enhancing the QMS processes including:

  • Device Software Development

  • Design Controls

  • Risk Management

  • Post Market and Premarket Cybersecurity

  • Experience working with Medical Device Software Advocacy, Standards and Professional Organizations (i.e. AAMI; MDIC; IEC; FDA; AdvaMed; NIST; IMDRF)

  • Formal Project Management Experience

  • CAPA, Vendor Controls, Complaint Handling and Internal/External Audits Experience

  • Software Development Tools Experience (i.e. Jira; Cockpit; Github; Codenvy; Bitbucket)

Requisition ID: 630662
Minimum Salary: $ 85000
Maximum Salary: $ 161500
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

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