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Home Based Medical Device Software Engineer Jobs

The ideal candidate has experience validating software-based medical devices as well as strong ... Performs validation of non-medical-device software tools and supporting systems as required ...

Collaborate with product development, quality, clinical, and engineering teams to ensure regulatory ... Interpret FDA guidance related to medical device software and digital health technologies * Partner ...

Software Engineer III

Monroeville, PA · On-site

$57 - $76.50/hr

Analyzing and verifying medical device designs. * *Writing detailed automated and manual test ... Makes risk-based decisions, balancing business and compliance issues. Plans and manages assignments ...

Be involved in the medical device software design controls activities, in accordance with the FDA ... Lead risk-based approach to host / computer system validation (HSV/CSV), SDLC and design controls ...

Be involved in the medical device software design controls activities, in accordance with the FDA ... Lead risk-based approach to host / computer system validation (HSV/CSV), SDLC and design controls ...

Be involved in the medical device software design controls activities, in accordance with the FDA ... Lead risk-based approach to host / computer system validation (HSV/CSV), SDLC and design controls ...

Lead Software Engineer

Newark, DE · On-site +1

$128K - $200K/yr

... based solutions that power the next generation of AI-enabled medical devices. In this role, you ... Ensure development processes align with medical device regulations and quality standards, including ...

Develop and test medical device software as part of an embedded system, document and troubleshoot ... The offered rate complies with federal and local regulations and may vary based on factors such as ...

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Home Based Medical Device Software Engineer information

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$63.5K

$147.5K

$205.5K

How much do home based medical device software engineer jobs pay per year?

As of Jun 25, 2026, the average yearly pay for home based medical device software engineer in the United States is $147,524.00, according to ZipRecruiter salary data. Most workers in this role earn between $120,000.00 and $173,000.00 per year, depending on experience, location, and employer.

What engineers make $300,000 a year?

Senior home-based medical device software engineers with extensive experience, specialized skills in embedded systems, regulatory compliance, and often advanced certifications can earn $300,000 or more annually. High compensation typically reflects leadership roles, complex project responsibilities, and working in high-demand or innovative healthcare technology environments.

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

To excel as a Home Based Medical Device Software Engineer, you need strong programming skills (often in C/C++ or Python), a background in software engineering or computer science, and knowledge of medical device regulations such as IEC 62304. Familiarity with version control systems (like Git), embedded systems development tools, and experience with quality management systems are typically required, along with certifications in medical device software or related fields. Excellent problem-solving, attention to detail, and effective remote communication are standout soft skills for this role. These competencies are vital for developing safe, compliant, and reliable medical device software while collaborating efficiently from a remote environment.

What does a Home Based Medical Device Software Engineer do?

A Home Based Medical Device Software Engineer is responsible for designing, developing, testing, and maintaining software used in medical devices, all while working remotely. They ensure that the software complies with regulatory standards for safety and efficacy, often collaborating with cross-functional teams such as hardware engineers and regulatory specialists. Their work helps create software for devices like pacemakers, insulin pumps, or diagnostic equipment, ultimately improving patient care. Remote work enables flexibility, but also requires strong communication skills and a reliable home office setup.

What is L1, L2, L3, and L4 developer?

In the context of a Home Based Medical Device Software Engineer, L1, L2, L3, and L4 typically refer to different levels of developer experience and responsibility, with L1 being entry-level and L4 being senior or lead roles. These levels often indicate increasing expertise in software development, testing, and regulatory compliance within medical device environments, and may influence salary, project scope, and required certifications.

What engineers make $500,000?

Senior home-based medical device software engineers with extensive experience, specialized skills in embedded systems, and advanced certifications can reach or exceed a $500,000 annual salary, especially in high-demand markets. Compensation often includes base salary, bonuses, and stock options, reflecting their expertise and leadership roles in the industry.

Can I work from home as a software engineer?

Home-based medical device software engineers often have the option to work remotely, especially when their tasks involve coding, testing, and documentation that can be done independently. However, some roles may require on-site presence for device testing, collaboration, or regulatory compliance. The availability of remote work depends on the employer, project requirements, and necessary certifications or tools like secure VPNs and collaboration platforms.

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

AspectHome Based Medical Device Software EngineerMedical Device Quality Assurance Specialist
CredentialsBachelor's in Software Engineering, Biomedical Engineering, or related field; certifications like CSTE or ISTQB beneficialBachelor's in Life Sciences, Quality Assurance, or related; certifications like CQE or ISO auditor preferred
Work EnvironmentRemote or home-based, collaborating with development teamsOn-site or remote, focusing on compliance and quality processes
Industry UsageDesigning and testing software for medical devicesEnsuring medical device manufacturing and software meet quality standards

While both roles support medical device development, the Home Based Medical Device Software Engineer focuses on software design and testing remotely, whereas the Medical Device Quality Assurance Specialist emphasizes compliance and quality assurance processes, often on-site or in regulated environments.

How does a Home Based Medical Device Software Engineer typically collaborate with cross-functional teams while working remotely?

As a Home Based Medical Device Software Engineer, collaboration with cross-functional teams is primarily achieved through virtual meetings, project management tools, and regular status updates. You’ll often work closely with QA specialists, regulatory affairs, hardware engineers, and clinical teams to ensure that the software meets safety and compliance standards. Effective communication and proactive engagement are essential, especially when troubleshooting issues or implementing new features. Most companies provide robust collaboration platforms and clear communication protocols to help remote engineers stay integrated with the broader team.
What cities are hiring for Home Based Medical Device Software Engineer jobs? Cities with the most Home Based Medical Device Software Engineer job openings:
What are the most commonly searched types of Medical Device Software Engineer jobs? The most popular types of Medical Device Software Engineer jobs are:
What states have the most Home Based Medical Device Software Engineer jobs? States with the most job openings for Home Based Medical Device Software Engineer jobs include:
Director, Software Architecture & Engineering

Director, Software Architecture & Engineering

Olympus Corporation of the Americas

Center Valley, PA • On-site, Remote

$239K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted yesterday


Olympus Corporation Of The Americas rating

7.9

Company rating: 7.9 out of 10

Based on 18 frontline employees who took The Breakroom Quiz

161st of 419 rated machine equipment manufacturers


Job description

Working Location: Nationwide 

Workplace Flexibility: Hybrid

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​

Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose: 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

Learn more about Life at Olympus: https://www.olympusamerica.com/careers.

Job Description

The Director of Software Architecture and Engineering is a senior technology leader responsible for defining and executing the architecture and engineering strategy for medical devices, connected health platforms, and regulated healthcare technologies. This role ensures the development of secure, scalable, compliant, and high-quality software systems aligned with global regulatory standards.

This role involves overseeing the development of scalable, secure, and efficient systems, ensuring alignment with regulatory standards and industry best practices. It collaborates with cross-functional teams to drive technology initiatives, act as architecture subject matter expert for architectural design discussions and decisions, drive the decommissioning agenda, optimize infrastructure, and enhance the overall digital transformation strategy.

The ideal candidate brings deep expertise in regulated software development (FDA, ISO, IEC), embedded and cloud-connected systems, cybersecurity, and engineering leadership within medical device or digital health environments.

Job Duties

Technology Strategy & Architecture Vision

  • Define and lead the long-term architecture strategy for medical devices and connected health platforms.
  • Drive innovation in Software as a Medical Device (SaMD), embedded systems, IoT-enabled devices, and cloud integration.
  • Align engineering strategy with product roadmaps, regulatory requirements, and commercialization goals.
  • Evaluate emerging technologies in digital health, remote monitoring, AI/ML-enabled diagnostics, and edge computing.

Medical Device Software Architecture

  • Oversee architecture for:
    • Cloud-connected device platforms
    • Mobile and web applications supporting devices
  • Ensure system interoperability (HL7, FHIR, DICOM where applicable).
  • Establish secure device-to-cloud communication architectures.
  • Define cybersecurity-by-design frameworks aligned with FDA and global guidance.

Regulatory & Compliance Leadership

  • Ensure compliance with:
    • FDA 21 CFR Part 820 / Part 11
    • ISO 13485
    • IEC 62304 (Medical Device Software Lifecycle)
    • ISO 14971 (Risk Management)
    • GDPR / HIPAA (as applicable)
  • Oversee Design Controls, Verification & Validation (V&V), and documentation processes.
  • Lead software risk management and hazard analysis activities.
  • Support regulatory submissions (510(k), CE marking, etc.) from a software perspective.

Engineering Execution & Quality

  • Lead cross-functional engineering teams (software, firmware, systems, DevOps, QA).
  • Implement secure software development lifecycle (SSDLC) practices.
  • Establish CI/CD processes suitable for regulated environments.
  • Drive system reliability, performance, and traceability across the product lifecycle.
  • Oversee technical documentation and audit readiness.

Organizational Leadership & Talent Development

  • Build and scale high-performing engineering and architecture teams.
  • Mentor engineering leaders and principal architects.
  • Establish engineering KPIs aligned with product quality and compliance.
  • Foster a culture of accountability, innovation, and regulatory excellence.

Executive & Cross-Functional Collaboration

  • Partner with Regulatory Affairs, Quality, Clinical, Product, and Manufacturing teams.
  • Translate technical architecture into regulatory and business impact for executives.
  • Participate in customer, auditor, and regulatory agency engagements.
  • Support M&A technical due diligence when applicable.
Job Quaifications

Required:

  • Bachelor’s or Master’s degree in Computer Science, Software Engineering, Biomedical Engineering, Electrical Engineering, or related field.
  • Minimum of 12 to 15 years of progressive software engineering experience.
  • Minimum of 5 years in senior leadership roles in medical devices or regulated healthcare technology.
  • Deep expertise in IEC 62304-compliant software development.
  • Experience with connected medical devices.
  • Strong understanding of cloud architecture (AWS, Azure, or GCP).
  • Proven experience supporting regulatory audits and submissions.
  • Experience leading multidisciplinary engineering teams.

Preferred:

  • Experience with Software as a Medical Device (SaMD).
  • Familiarity with AI/ML in regulated healthcare products.
  • Experience with cybersecurity standards (e.g., FDA cybersecurity guidance, NIST).
  • Knowledge of interoperability standards (HL7, FHIR, DICOM).
  • Cloud and/or medical device quality certifications.
  • Experience in global regulatory environments (FDA, EU MDR, Health Canada, etc.).

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on:

  • Competitive salaries, annual bonus and 401(k)* with company match

  • Comprehensive medical, dental, vision coverage effective on start date

  • 24/7 Employee Assistance Program

  • Free live and on-demand Wellbeing Programs

  • Generous Paid Vacation and Sick Time

  • Paid Parental Leave and Adoption Assistance*

  • 12 Paid Holidays

  • On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

  • Work-life integrated culture that supports an employee centric mindset

  • Offers onsite, hybrid and field work environments

  • Paid volunteering and charitable donation/match programs

  • Employee Resource Groups

  • Dedicated Training Resources and Learning & Development Programs

  • Paid Educational Assistance

*US Only

**Center Valley, PA and Westborough, MA

Are you ready to be a part of our team?

Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.

The anticipated base pay range for this full-time position in this location is $144,541.00 - $216,812.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). 

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. 

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

 

Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Research and Development 


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