Pediatric Implant R&D Lead (Hands-On)

Renata Medical; Newport Beach (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Full benefits package

Bonus potential

Equity

Job summary

Renata Medical is seeking a Manager of Research & Development to lead a novel pediatric implant program from concept to design transfer. This working leadership role requires hands-on device design, prototyping, and test-method development while also building the program plan and coordinating cross-functional teams.

You will partner with interventional cardiologists and congenital heart specialists to translate clinical needs into an implantable solution, mentor engineers, and report progress

Qualifications

• Bachelor's degree in mechanical, biomedical, materials, or a related engineering discipline.
• 8+ years of medical device product development experience.
• Must have owned or been the primary designer on a permanently implanted device with design freeze and verification testing.
• Experience leading a development program as technical owner with cross-functional delivery.
• Class III device development under an established quality system with hands-on design controls.
• Hands-on design competency: CAD modeling, materials selection, prototyping, test method development.
• Experience selecting and managing suppliers and contract manufacturers.
• Experience collaborating with physicians and KOLs to translate clinical feedback into design requirements.

Responsibilities

• Own the program schedule: build the project plan, define deliverables and owners across functions, drive committed dates.
• Lead the technical design of the implant and delivery system from concept through design freeze while remaining hands-on.
• Run the design control process: design inputs/outputs, risk management, verification/validation, design history file.
• Drive team-level risk identification and closure; manage in vivo device behavior and mitigations.
• Define testing/validation strategy and coordinate bench, biocompatibility, and preclinical execution.
• Coordinate cross-functional execution across Quality, Regulatory, Manufacturing/Operations, and Clinical.
• Manage supplier and contract manufacturer relationships and expectations.
• Mentor engineers, hire and guide staff as the team grows; report status to leadership and board.

Skills

Medical device development

Project leadership

Design controls

CAD modeling

Vendor management

Regulatory collaboration

KOL collaboration

Risk management

Education

Bachelor's degree in mechanical, biomedical, or related engineering

Tools

CREO CAD

Job description

Renata Medical is seeking a Manager of Research & Development to lead a novel pediatric implant program from concept to design transfer. This working leadership role requires hands-on device design, prototyping, and test-method development while also building the program plan and coordinating cross-functional teams.

You will partner with interventional cardiologists and congenital heart specialists to translate clinical needs into an implantable solution, mentor engineers, and report progress