Technical Program Manager, Medical Device Hardware

Technical Program Manager, Medical Device Hardware

Location:

Newark, NJ

Employment Type:

Full time
Location Type:
Hybrid (3 days in lab)

The Technical Program Manager at Lura Health will play a key role in pushing the boundaries of innovation while working out of the vibrant HAX coworking space.

Lura Health is a fast‑growing, VC and NSF‑backed early‑stage medical device company developing a non-invasive remote patient monitoring device. The primary technology is a highly miniaturized sensor that is worn in the mouth, continually records analytes in saliva related to chronic disease, and automatically transmits data to a patient’s smartphone via Bluetooth Low Energy. The data is then shared to the cloud for storage, analysis, and review by doctors and medical professionals.

The approach has the potential for less invasive and more user-friendly health management.

The company is in the clinical study phase and approaching an FDA design freeze. We are welcoming a Technical Program Manager to drive key projects related to hardware production currently in the Engineering Validation phase, and soon in the Design Validation and Production Validation phases.

• Technical Program Management
  • Build and maintain digital project management systems (e.g. Notion, Asana) for building, refining, executing, and reporting on hardware, software, and embedded firmware projects.
  • Scope and build new SMART projects with input from engineers, business operations managers, quality managers, and product leads.
  • Communicate project statuses across teams. Continuously update projects on an ongoing basis with project managers to reflect actual versus forecasted timelines and budgets.
  • Identify and eliminate timeline blockers to ensure reliable delivery schedules.
  • Maintain and communicate accountability metrics across the team.
  • Build full confidence and trust with the engineering and executive team to take on key work streams.
• Supply Chain and Vendor Management
  • Assume overall responsibility for the proper sourcing and procurement of materials.
  • Build and maintain close business relationships with key R&D vendors.
  • Directly manage all communications and logistics of all hardware builds (electronics, mechanics) from after the engineer submits production files, to when the parts arrive on the engineer’s desk.
  • Direct all communications between external vendors and internal team members (e.g. Engineering).
  • Control and measure inventory level of materials.
  • Communicates and negotiates vendor quotes and Scope of Work agreements with external vendors, engineers, and executives.
  • Quote and engage secondary suppliers to build supply‑chain resilience.
• Design Control
  • Assume responsibility that engineering builds and testing comply with proper medical device documentation and design inputs, as directed by the Quality Manager.
  • Assist Quality Manager in maintaining and growing the design control system per ISO 13485.

• At least 1 product development cycle driving a medical device through design freeze and FDA clearance
• Bachelor of Science in Engineering (Mechanical, Electrical, Electro‑Mechanical, or Biomedical); advanced degrees are a plus.
• Direct experience developing and producing high‑density Printed Circuit Boards
• Supply chain management experience
• Working knowledge of FDA regulations related to the medical device industry, including design controls for FDA Class II
• Proven experience in Program Management in the medical device industry
• Advanced experience with program management software (e.g. project management, vendor management, inventory management)
• Experience operating under Quality Management System (ISO 13485)
• Role is based in Newark, NJ; 3 days per week in lab

Nice‑to‑Have: PMP certification, CAD knowledge, exposure to embedded/mobile/cloud software, aptitude for leveraging AI and automation tools (Make, Zapier, ChatGPT) for systems development.

• High Urgency
• Strong follow-through
• Ability to build trust quickly. Strong teamwork skills.
• Systems‑based scalable thinking
• Passionate about achieving under hard deadlines
• Strong teamwork
• Problem‑solving, facilitating discussions, managing and…