Are you an experienced leader with a passion for driving innovation in medical device systems engineering? We are seeking a Director of Systems Engineering (Med Device) in Dallas, TX, to lead the development, integration, and optimization of cutting-edge medical technologies. This role demands a visionary professional with expertise in systems architecture, regulatory compliance, risk management, and cross-functional collaboration within the medical device sector.
As the Director of Systems Engineering (Med Device) in Dallas, TX, you will play a critical role in defining system requirements, enhancing design processes, and ensuring compliance with FDA, ISO, and IEC standards. If you excel at leading multidisciplinary teams, driving product innovation, and optimizing system performance, this executive opportunity is tailored for you.
About This Role
The Director of Systems Engineering (Med Device) in Dallas, TX will oversee the end-to-end systems engineering process, ensuring the successful development of highly regulated medical devices. This role requires expertise in product lifecycle management, risk assessment, design verification & validation, and regulatory compliance. You will collaborate with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to drive technical excellence and system integration.
As a key leader, the Director of Systems Engineering (Med Device) in Dallas, TX will develop strategies for optimizing system architecture, improving risk management processes, and enhancing product reliability. This role presents an exciting opportunity to work on innovative medical device technologies while ensuring compliance with stringent industry regulations and delivering best-in-class healthcare solutions.
Key Responsibilities – Director of Systems Engineering (Med Device) in Dallas, TX
1. Lead Systems Engineering Strategy & Development
- Define and implement systems engineering best practices for medical device development.
- Develop long-term engineering roadmaps that align with company objectives and regulatory requirements.
- Ensure the integration of cutting-edge technologies to enhance device functionality and performance.
2. Oversee System Architecture & Design
- Establish scalable and modular system architectures for medical devices.
- Collaborate with cross-functional teams to ensure seamless integration of hardware, software, and firmware.
- Optimize system designs for performance, reliability, and manufacturability.
3. Drive Risk Management & Compliance
- Implement risk management processes (ISO 14971) to mitigate potential hazards.
- Ensure compliance with FDA, IEC 60601, ISO 13485, and other relevant medical device regulations.
- Conduct design failure mode and effects analysis (DFMEA) and risk assessments.
4. Manage Design Verification & Validation (V&V)
- Oversee design verification and validation processes to ensure product efficacy and safety.
- Develop and execute test plans, protocols, and reports in alignment with regulatory requirements.
- Work closely with Quality and Regulatory teams to support product submissions and audits.
5. Drive Cross-Functional Collaboration
- Serve as the technical liaison between R&D, Quality Assurance, Regulatory, and Manufacturing teams.
- Align engineering efforts with market needs, business objectives, and customer requirements.
- Facilitate effective communication between internal stakeholders and external partners.
6. Optimize Product Lifecycle Management (PLM)
- Establish and oversee PLM processes to enhance product development efficiency.
- Ensure seamless transition from concept to commercialization while maintaining regulatory compliance.
- Monitor post-market performance and drive continuous product improvements.
7. Lead & Mentor Engineering Teams
- Build, mentor, and develop a high-performing systems engineering team.
- Foster a culture of innovation, collaboration, and technical excellence.
- Provide technical leadership, coaching, and professional growth opportunities.
8. Implement Emerging Technologies & Innovation
- Evaluate and integrate emerging technologies such as AI, IoT, and automation in medical device systems.
- Drive continuous improvement initiatives to enhance system efficiency and product differentiation.
- Partner with external research institutions and technology providers to stay ahead of industry trends.
What The Client is Looking For in You
To succeed as the Director of Systems Engineering (Med Device) in Dallas, TX, you must be a strategic thinker, an expert in systems engineering, and a strong leader who can drive medical device development from concept to commercialization. The ideal candidate will possess:
- Extensive Experience in Medical Device Systems Engineering – A minimum of 10+ years of experience in systems engineering, product development, and regulatory compliance within the medical device industry.
- Deep Technical Knowledge – Strong expertise in systems architecture, risk management (ISO 14971), design controls (21 CFR Part 820), and regulatory compliance (FDA, IEC 60601, ISO 13485, and EU MDR).
- Proven Leadership & Team Management – Experience leading multidisciplinary engineering teams while fostering collaboration, technical excellence, and innovation.
- Product Lifecycle & Regulatory Expertise – A track record of successfully bringing medical devices to market, from feasibility to FDA approval and post-market support.
- Risk & Compliance Management – Hands-on experience in implementing risk mitigation strategies, design verification & validation (V&V), and compliance with industry standards.
- Strong Communication & Cross-Functional Collaboration – Ability to work across engineering, R&D, regulatory, quality, and manufacturing teams to align product development with business objectives.
- Strategic & Analytical Mindset – A forward-thinking approach to systems engineering, problem-solving, and process optimization to enhance product efficiency and market success.
Why This Opportunity Stands Out
This role offers an exceptional career opportunity for a seasoned systems engineering leader in the medical device space. Here’s why this position is unique and highly rewarding:
- Lead Cutting-Edge Medical Device Innovation – Play a key role in developing life-changing healthcare technologies that improve patient outcomes.
- Work with a High-Growth, Industry-Leading Company – Join a rapidly expanding organization known for its innovation, quality, and leadership in the medical device sector.
- Drive Regulatory & Compliance Excellence – Be at the forefront of ensuring industry-leading regulatory and risk management processes that impact global healthcare.
- Executive-Level Impact & Visibility – Report directly to the VP of Engineering and collaborate closely with the executive leadership team to shape the company’s technology roadmap.
- Competitive Compensation & Executive Benefits – Enjoy a lucrative salary, performance-based incentives, and comprehensive benefits, including healthcare, 401(k), and professional development programs.
- Professional Growth & Leadership Development – This role provides an opportunity to mentor top-tier engineering teams, implement next-gen medical device technologies, and influence global market strategies.
- Dynamic & Collaborative Culture – Work in an environment that values technical expertise, teamwork, and a passion for advancing medical technology.
FAQs About the Role
Q: What industries should I have experience in?
A: You should have a strong background in medical devices, specifically in systems engineering, risk management, and regulatory compliance. Experience in highly regulated industries like biotechnology, pharmaceuticals, or healthcare technology is also valuable.
Q: Is relocation required for this position?
A: The role is based in Dallas, TX. Candidates must be open to relocation or already reside in the area.
Q: What is the reporting structure for this role?
A: The Director of Systems Engineering (Med Device) in Dallas, TX will report directly to the VP of Engineering and work closely with R&D, Quality, Regulatory, and Manufacturing teams.
Q: What kind of leadership style is expected?
A: We seek a collaborative, strategic, and results-driven leader who can mentor teams, drive process improvements, and align engineering initiatives with business objectives.
Q: What is the expected travel requirement?
A: This role may require occasional domestic and international travel for supplier collaboration, industry conferences, and regulatory compliance meetings.
Q: What qualifications and skills are required?
A: A bachelor’s or master’s degree in systems engineering, mechanical engineering, biomedical engineering, or a related field is required. Candidates should also have at least 10+ years of experience in medical device systems engineering and strong expertise in regulatory compliance and risk management.
Q: How does this role contribute to the company’s overall success?
A: The Director of Systems Engineering (Med Device) in Dallas, TX is critical in ensuring product integrity, optimizing system performance, and navigating regulatory challenges, which directly impacts company growth, market success, and product innovation.
Q: What is the timeline for hiring and onboarding?
A: The company is actively hiring and aims to complete the hiring process within 60–90 days. Onboarding will include strategy meetings, cross-functional team introductions, and deep dives into current product development pipelines.
What Remuneration Can You Expect from This Job?
As the Director of Systems Engineering (Med Device) in Dallas, TX, you can expect a highly competitive compensation package that reflects your leadership role and expertise in medical device systems engineering. The base salary for this position typically ranges from $180,000 – $220,000 per year, depending on experience, technical expertise, and past contributions to medical device development.
In addition to the base salary, this role includes performance-based bonuses and incentives tied to key engineering and business milestones, such as successful product launches, regulatory approvals, and process optimizations. Equity options or stock grants may also be available, offering long-term financial growth opportunities.
The benefits package includes comprehensive healthcare coverage (medical, dental, and vision), a 401(k) retirement plan with company matching, paid time off (PTO), and professional development opportunities such as leadership training, industry conferences, and certification support. Additional perks may include relocation assistance, travel allowances, and executive-level benefits.
This role offers not only a lucrative financial package but also the opportunity to drive innovation in the medical device industry, lead high-impact engineering teams, and contribute to life-changing healthcare solutions.
How to Apply for This Director of Systems Engineering (Med Device) Position in Dallas, TX
If you are an experienced systems engineering leader with a strong background in medical device development, regulatory compliance, and cross-functional leadership, we encourage you to apply for the Director of Systems Engineering (Med Device) in Dallas, TX. This is an exciting opportunity to lead cutting-edge product development and drive innovation in healthcare technology.
To apply, please submit your resume and a cover letter detailing your experience in systems engineering, risk management, product development, and regulatory compliance within the medical device industry.
This role offers a rewarding career opportunity to work with a market-leading medical device company, leading high-performing engineering teams and contributing to groundbreaking medical technologies. Apply today to take the next step in your career as the Director of Systems Engineering (Med Device) in Dallas, TX!
For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.
Tags:
Director of Systems Engineering | Medical Device Engineering | Systems Engineering Leadership | Product Development | Risk Management
