Director of Software Engineering (Medical Device) in Houston, TX

Are you a seasoned software engineering leader with a passion for developing cutting-edge medical device technology? We are seeking a Director of Software Engineering (Medical Device) in Houston, TX to drive innovation, oversee software development, and ensure compliance with regulatory standards in the healthcare industry. This executive role requires a hands-on leader with a deep understanding of embedded systems, software architecture, and medical device software development. If you have a track record of leading high-performing engineering teams and delivering FDA-compliant software solutions, this is the opportunity for you.

About This Role

The Director of Software Engineering (Medical Device) in Houston, TX will play a critical role in leading software development initiatives, ensuring that medical device products meet the highest standards of quality, safety, and innovation. This role involves spearheading the design and implementation of software solutions, collaborating with cross-functional teams, and ensuring compliance with regulatory bodies such as the FDA and ISO. The ideal candidate will have expertise in embedded software, cloud-based solutions, AI-driven applications, and cybersecurity within the medical device space. By leading a team of talented engineers and fostering a culture of excellence, the Director of Software Engineering (Medical Device) in Houston, TX will contribute to shaping the future of healthcare technology.

Key Responsibilities – Director of Software Engineering (Medical Device) in Houston, TX

1. Lead Software Development and Engineering Strategy

Define and execute the software engineering vision and roadmap for medical device products.
Oversee the entire software development lifecycle, from concept to deployment and maintenance.
Ensure that all software solutions align with business objectives, industry trends, and regulatory requirements.

2. Manage and Develop High-Performing Engineering Teams

Recruit, mentor, and lead a team of software engineers, ensuring continuous growth and development.
Foster a collaborative and innovative engineering culture that encourages best practices.
Implement agile development methodologies to enhance productivity and efficiency.

3. Ensure Regulatory Compliance and Quality Assurance

Oversee software development processes to comply with FDA, ISO 13485, IEC 62304, and HIPAA standards.
Work closely with regulatory affairs and quality assurance teams to maintain documentation and approvals.
Implement rigorous testing and validation procedures to ensure software reliability and safety.

4. Drive Innovation in Medical Device Software Solutions

Lead the development of AI-powered diagnostics, cloud-based platforms, and cybersecurity protocols.
Stay ahead of emerging technologies and assess their applicability to medical devices.
Partner with R&D teams to integrate new software features that enhance patient outcomes.

5. Oversee Software Architecture and System Integration

Define software architecture best practices for medical devices and healthcare applications.
Ensure seamless integration between hardware, firmware, and software components.
Collaborate with hardware engineers and data scientists to optimize system performance.

6. Collaborate with Cross-Functional Teams

Work closely with product managers, regulatory teams, and clinical experts to align software features with user needs.
Participate in strategic decision-making regarding software product roadmaps.
Communicate technical concepts to non-technical stakeholders, including executives and investors.

7. Manage Risk and Cybersecurity for Medical Software

Develop and implement cybersecurity frameworks to protect patient data and comply with regulations.
Conduct risk assessments to identify vulnerabilities in medical software systems.
Ensure that software updates and patches adhere to security best practices.

8. Oversee Software Testing and Validation Processes

Implement automated and manual testing to ensure software quality and reliability.
Monitor performance metrics and debug issues to enhance software efficiency.
Ensure seamless usability for healthcare professionals and patients using the medical device software.

What The Client is Looking For in You

To thrive as the Director of Software Engineering (Medical Device) in Houston, TX, you must be a visionary leader with a strong technical foundation and a passion for advancing medical device technology. The ideal candidate will possess:

Extensive Software Engineering Experience in the Medical Device Industry – A deep understanding of embedded systems, real-time software, AI-driven applications, and cloud-based healthcare solutions, with a proven track record of delivering FDA-compliant medical device software.
Regulatory and Compliance Expertise – In-depth knowledge of FDA regulations, ISO 13485, IEC 62304, HIPAA, and cybersecurity best practices for medical device software development.
Strategic Leadership and Team Management – Experience leading high-performing engineering teams, fostering a culture of innovation, and driving product development from ideation to launch.
Technical Excellence in Software Architecture – Proficiency in C++, Python, Java, or other relevant programming languages, with a strong grasp of cloud computing, machine learning, and IoT integration for medical devices.
Cross-Functional Collaboration Skills – Ability to work closely with R&D teams, product managers, regulatory affairs, and clinical experts to develop cutting-edge medical device solutions.
Problem-Solving and Innovation – A results-driven mindset with the ability to identify software challenges, develop creative solutions, and stay ahead of emerging healthcare technologies.
Strong Communication and Stakeholder Engagement – Ability to translate technical concepts into business value and effectively communicate with executives, investors, and cross-functional teams.
Commitment to Quality and Patient Safety – A deep passion for creating software solutions that enhance patient outcomes, improve healthcare workflows, and adhere to the highest quality standards.

Why This Opportunity Stands Out

The Director of Software Engineering (Medical Device) in Houston, TX position offers a unique chance to lead the development of groundbreaking medical technology while working with a company that prioritizes innovation, patient impact, and long-term growth. Here’s why this role is an exceptional opportunity:

Lead Next-Generation Medical Device Software Development – Spearhead AI-driven diagnostics, cloud-based healthcare solutions, and secure medical software applications that will shape the future of patient care.
Be Part of a High-Growth, Innovation-Driven Organization – Join a company that is expanding rapidly, offering exciting career advancement and leadership opportunities.
Competitive Compensation & Executive Benefits – Enjoy a highly competitive salary, performance-based bonuses, stock options, and executive-level perks that reflect the impact of this leadership role.
Make a Meaningful Impact on Healthcare – Your work will contribute directly to life-saving medical technologies, improved patient outcomes, and enhanced healthcare efficiency.
Collaborate with Industry Leaders & Experts – Work alongside top-tier engineers, regulatory professionals, and medical innovators in a dynamic and fast-paced environment.
Strong Investment in R&D and Cutting-Edge Technologies – Gain access to state-of-the-art resources, advanced research initiatives, and a culture that fosters continuous learning and growth.
Opportunity to Drive Digital Transformation in Healthcare – Take part in leveraging AI, IoT, and cloud computing to revolutionize the way medical devices interact with healthcare ecosystems.

FAQs About the Role

Q: What industries should I have experience in?
A: You should have a strong background in medical device software development, with experience in embedded systems, AI applications, and cloud-based healthcare solutions. Experience in regulated industries like pharmaceuticals, biotech, or healthcare technology is also valuable.

Q: Is relocation required for this position?
A: This role is based in Houston, TX. Candidates must be open to relocating or already reside in the area. Relocation assistance may be available for highly qualified candidates.

Q: What is the reporting structure for this role?
A: The Director of Software Engineering (Medical Device) in Houston, TX will report directly to the Chief Technology Officer (CTO) and collaborate closely with the executive leadership team.

Q: What kind of leadership style is expected?
A: We are looking for a strategic and hands-on leader who can mentor engineers, drive technical excellence, and foster a culture of innovation and collaboration.

Q: What is the expected travel requirement?
A: While the role is primarily based in Houston, TX, occasional domestic and international travel may be required for industry conferences, regulatory meetings, and partner collaborations.

Q: What qualifications and skills are required?
A: Candidates should have:

A bachelor’s or master’s degree in software engineering, computer science, or a related field.
At least 10+ years of experience in software development for medical devices.
Proficiency in regulatory standards like IEC 62304, ISO 13485, and FDA software validation.
Expertise in cloud platforms (AWS, Azure), AI applications, and cybersecurity protocols.

Q: How does this role contribute to the company’s overall success?
A: The Director of Software Engineering (Medical Device) in Houston, TX will play a critical role in driving software innovation, ensuring regulatory compliance, and leading high-impact medical device software development initiatives. This position directly impacts revenue growth, market expansion, and product success.

Q: What is the timeline for hiring and onboarding?
A: The company is actively recruiting for this position and aims to complete the hiring process within the next 60–90 days. Onboarding will include:

An in-depth introduction to the company’s technology stack and product roadmap.
Meetings with key stakeholders across engineering, product, and regulatory teams.
Alignment on software development goals and long-term strategic initiatives.

What Remuneration Can You Expect from This Job?

The Director of Software Engineering (Medical Device) in Houston, TX role offers a highly competitive compensation package that reflects the critical nature of this leadership position in the medical device industry. Candidates can expect a base salary in the range of $180,000 to $230,000 per year, depending on experience, qualifications, and expertise in regulatory-compliant software development.

In addition to a strong base salary, this position includes performance-based bonuses tied to project milestones, team success, and overall company growth. The bonus structure can add 15-25% of the base salary annually for top performers. Stock options or equity grants may also be available for candidates who bring exceptional leadership and innovation to the organization.

The benefits package includes comprehensive healthcare coverage (medical, dental, and vision), 401(k) with company match, paid time off (PTO), and flexible working arrangements. Additional executive-level perks such as relocation assistance, professional development programs, and company-sponsored training ensure long-term career growth.

This role provides an exciting opportunity to be financially rewarded while making a meaningful impact on medical technology advancements. The company values its leaders and invests in their success through competitive pay and long-term incentives.

How to Apply for This Director of Software Engineering (Medical Device) Position in Houston, TX

If you are a highly experienced software engineering leader with a strong background in medical device software development, regulatory compliance, and innovative technology solutions, we invite you to apply for the Director of Software Engineering (Medical Device) in Houston, TX. This is a strategic leadership role where you will drive software innovation, ensure compliance with FDA and ISO standards, and lead high-performing engineering teams.

To apply, please submit your resume and a cover letter detailing your experience in software architecture, regulatory-compliant development, cybersecurity, and leadership within the medical device industry.

This position offers a high-impact opportunity to shape the future of medical device software, enhance patient outcomes, and lead groundbreaking innovations in healthcare technology. Apply today to take the next step in your executive software engineering career as a Director of Software Engineering (Medical Device) in Houston, TX!

For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.

Tags:

Job Category: Director of Software Engineering

Job Type: Full Time

Job Location: Houston