Medical Device Product Engineer
6 - 10 years
Burleson, TX
$110k - $135k/year
Full-time
Hybrid
1 month ago
About the role
Position: Medical Device Product Engineer
Status: Full-Time (hybrid) (This position is not eligible for visa sponsorship now or in the future)
Shift: Days
Location: Burleson, TX
Reports to: COO
Company Overview
Precision Monitoring is a leading innovator in healthcare diagnostics, offering remote monitoring and enterprise management solutions that drive better outcomes across the healthcare continuum. We specialize in Holter, Event, and Telemetry monitoring systems that simplify complex workflows for providers operating in a highly regulated environment.
Our culture promotes analytical thinking, innovation, and a commitment to excellence. As we continue to expand, we’re seeking passionate professionals who bring energy, integrity, and a results-driven mindset to join our growing team. We offer competitive compensation, comprehensive medical benefits, and a collaborative work environment.
Position Summary
The Medical Device Product Engineer will play a critical role in supporting product design, development, testing, and lifecycle management across Precision Monitoring’s hardware, software-integrated systems, and related accessories. This role will help ensure our products meet performance, usability, quality, and regulatory expectations while partnering cross-functionally to support innovation, commercialization, and sustaining engineering activities.
Key Responsibilities
Quality & Regulatory Compliance
Cross-Functional Collaboration
Qualifications
Key Competencies
Equal Opportunity Statement
Precision Monitoring is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace and do not discriminate based on race, color, religion, gender, national origin, age, disability, genetics, veteran status, sexual orientation, or any other protected characteristic under applicable law. This policy applies to all employment practices including hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Status: Full-Time (hybrid) (This position is not eligible for visa sponsorship now or in the future)
Shift: Days
Location: Burleson, TX
Reports to: COO
Company Overview
Precision Monitoring is a leading innovator in healthcare diagnostics, offering remote monitoring and enterprise management solutions that drive better outcomes across the healthcare continuum. We specialize in Holter, Event, and Telemetry monitoring systems that simplify complex workflows for providers operating in a highly regulated environment.
Our culture promotes analytical thinking, innovation, and a commitment to excellence. As we continue to expand, we’re seeking passionate professionals who bring energy, integrity, and a results-driven mindset to join our growing team. We offer competitive compensation, comprehensive medical benefits, and a collaborative work environment.
Position Summary
The Medical Device Product Engineer will play a critical role in supporting product design, development, testing, and lifecycle management across Precision Monitoring’s hardware, software-integrated systems, and related accessories. This role will help ensure our products meet performance, usability, quality, and regulatory expectations while partnering cross-functionally to support innovation, commercialization, and sustaining engineering activities.
Key Responsibilities
- Support the design, development, testing, and continuous improvement of medical device products and related accessories.
- Participate in the full product lifecycle, including concept development, design inputs/outputs, verification, validation, launch, and post-market support.
- Collaborate with cross-functional teams to translate business, technical, and clinical needs into product requirements and engineering deliverables.
- Evaluate and improve existing product performance, reliability, manufacturability, and usability.
- Assist in root cause analysis and troubleshooting of product issues, nonconformances, field complaints, and technical escalations.
- Develop and review engineering specifications, drawings, bills of materials (BOMs), test protocols, and supporting technical documentation.
- Support design changes, engineering change orders (ECOs), and product updates in a controlled environment.
- Create and execute verification and validation plans, protocols, and reports for new and existing products.
- Support bench testing, environmental testing, usability testing, and product performance evaluations.
- Analyze test data and document results to support engineering decisions, quality objectives, and regulatory submissions.
Quality & Regulatory Compliance
- Ensure product development activities align with FDA, ISO 13485, and applicable medical device design control requirements.
- Support risk management activities including FMEA, hazard analysis, and mitigation planning.
- Maintain engineering documentation in compliance with internal quality systems and external regulatory requirements.
- Partner with Quality and Regulatory teams to support audits, CAPAs, complaints, and Design History File (DHF) documentation.
Cross-Functional Collaboration
- Work closely with Product, Software, Operations, Manufacturing, Clinical, and Customer Support teams to support product success.
- Support manufacturing and supply chain teams with product transfers, component evaluations, and production-related technical issues.
- Participate in design reviews and contribute to product roadmap discussions, enhancements, and technical decision-making.
- Serve as a technical resource for internal stakeholders and, when needed, customer-facing support teams.
Qualifications
- Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Systems Engineering, or related technical field required.
- 3+ years of experience in product engineering, R&D, or design engineering within the medical device industry.
- Experience working in a regulated medical device environment with knowledge of design controls.
- Experience with Hardware/Firmware (C#, React, Azure DevOps, .Net, Typescript, Java, Angular)
- Familiarity with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and general medical device compliance requirements.
- Experience supporting product verification and validation testing and technical documentation.
- Strong analytical, troubleshooting, and problem-solving skills.
- Ability to work cross-functionally in a fast-paced, evolving environment.
- Strong written and verbal communication skills.
- Experience with cardiac monitoring, diagnostic devices, wearable devices, or patient monitoring systems preferred.
- Experience with hardware/software integrated products preferred.
- Knowledge of risk management tools such as FMEA and root cause analysis methodologies preferred.
- Experience in software development or product improvement initiatives is a plus.
- Familiarity with manufacturing processes, supplier quality, design transfer, CAPA support, and post-market product improvements preferred.
- Strong vendor management
Key Competencies
- Product Development
- Medical Device Design Controls
- Verification & Validation
- Risk Management
- Cross-Functional Collaboration
- Technical Documentation
- Problem Solving & Root Cause Analysis
- Regulatory & Quality Compliance
- Continuous Improvement
- Engineering Change Management
- Vendor Management
Equal Opportunity Statement
Precision Monitoring is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace and do not discriminate based on race, color, religion, gender, national origin, age, disability, genetics, veteran status, sexual orientation, or any other protected characteristic under applicable law. This policy applies to all employment practices including hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.