Principal Hardware Engineer

Jobtailor; Colorado; On-site; USD 120,000 - 160,000; Full time

Job summary

Jobtailor is seeking an experienced Senior Hardware Engineer to own electrical requirements for medical devices and drive hardware performance and manufacturability across new and existing products.

You will lead schematic reviews, PCB layouts, component selection and testing strategies, collaborating with software, mechanical, systems and manufacturing teams to deliver integrated solutions while ensuring regulatory compliance and high-quality results.

Qualifications

• 10+ years' medical device experience in systems/digital/software.
• Experience in 5+ major product or portfolio releases.
• Regulated product industry experience is a plus.
• Strong ability to understand complex system behaviors and constraints.
• Design portfolio demonstrating past work.
• Excellent communication skills, both written and verbal.

Responsibilities

• Own electrical requirements for medical devices and drive hardware performance and manufacturability.
• Lead hardware testing deliverables for new and sustaining products.
• Provide technical direction for hardware platforms and ensure reliability.
• Drive root cause investigations for complex issues.
• Review schematics and PCB layouts; select components.
• Collaborate with software, mechanical, systems and manufacturing teams.
• Develop and review hardware verification activities and tests.
• Ensure compliance with stage gate processes and regulatory standards.
• Evaluate emerging technologies for hardware improvements.

Skills

Hardware development

Electrical testing

Root cause analysis

System integration

Cross-functional collaboration

CAD

Schematic review

PCB layout

Battery tech

Regulatory knowledge

Wireless technology

Tools

CAD tools

Job description

Responsibilities

• Responsible for owning hardware and electrical requirements for new and existing products
• Strong electrical engineering fundamentals with extensive hands‑on hardware development experience and passion for coaching and developing engineers
• Serve as a subject matter expert for electrical and hardware design challenges
• Responsible for owning electrical testing deliverables on new and sustaining products
• Provide technical direction for hardware platforms, ensuring performance, reliability, manufacturing and scalability
• Drives root cause investigations and resolution of complex technical issues
• Deep knowledge of international standards (IEC 60601-1, 60601-2, CC 47CF$, ANSI C63.27, etc.)
• Deep knowledge of various wireless technologies, batteries, and battery‑powered systems
• Deep knowledge of CAD and other similar tools
• Develop and review schematics, PCB layouts and component selection
• Perform hardware debugging, verification and system integration activities
• Collaborate closely with software, mechanical, systems and manufacturing teams to deliver integrated solutions
• Evaluate emerging technologies and recommend improvements to existing hardware architectures
• Experiencing working with patient contacting devices and understanding of regulations around it
• Ability to manage ambiguity, work autonomously and keep organized and multitask
• Understand stage gate processes for projects within the medical device project lifecycle
• Organizational collaborator on DH&AICO enabled initiatives to leverage cross‑disciplinary and globally distributed teams to craft high‑quality products and services that customers love and drive preference
• Collaborate with other leaders to ensure successful development, release and launch of world‑class product (portfolio/program)

Requirements

• 10+ years' experience in the medical device industry in systems, digital or software development with proven record of accomplishment
• Knowledge of Agile methodology is nice to have
• Experience in 5+ major product or portfolio releases
• Experience in a regulated product industry is nice to have
• Ability to quickly understand complex system behaviors, engineering problems, technical and architectural constraints
• A robust design portfolio articulating past design work
• Excellent verbal and written communication skills with an aptitude for convincing others, both internally and externally, of the value of their ideas