Manager of R&D

Renata Medical•Newport Beach, CA

1d•$140,000

About The Position

Renata Medical is seeking a Manager of Research & Development to lead and develop a novel pediatric implant program from concept selection through design transfer. This is a working leadership role: the successful candidate will remain deeply hands-on in device design, prototyping, and test method development while simultaneously building the project plan, holding cross-functional owners to schedule, and reporting program status to executive leadership. The candidate will be the single point of accountability for the program's technical direction, timeline, and design history file. The role partners directly with interventional cardiologists and congenital heart specialists to translate a complex clinical need into an implantable solution, and coordinates the Quality, Regulatory, Manufacturing, and Clinical functions required to move the design forward. The Manager / Sr. Manager will provide technical mentorship on catheter and implant programs and will require direct reports. Renata is a fast-paced startup; this role suits a leader who is comfortable making design decisions with incomplete information, driving vendors and internal partners to commitments, and communicating progress and risk clearly and often. This role is atypical of a true management position and requires direct execution of engineering activities. This position reports to the Director of Research & Development.

Requirements

Bachelor’s degree in mechanical, biomedical, materials, or a related engineering discipline.
8+ years of medical device product development experience
Prior implant design experience is required. Candidates must have owned or been a primary designer on a permanently or long-term implanted device that progressed at minimum to design freeze and verification testing. This is a hard requirement and will not be waived.
Demonstrated experience leading a development program as the technical owner – building and holding a schedule, driving deliverables across functions, and reporting status to leadership.
Class III device development under an established quality system, including hands-on execution of Design Controls and risk management
Hands-on design competency: CAD modeling (CREO or equivalent), materials selection, physical prototyping, and test method development.
Experience selecting and managing suppliers and contract manufacturers through component development and build schedules.
Experience working directly with physicians and KOLs, including translating clinical feedback into design requirements.
Knowledge of relevant anatomy and procedural technique, with demonstrated ability to anticipate in vivo device behavior and failure modes and apply that judgment to guide design decisions.
Excellent written and verbal communication skills, including presenting technical status and risk to executive audiences.

Nice To Haves

Pediatric, congenital, or structural heart device experience.
Experience with transcatheter-delivered implants and their delivery systems.
Nitinol or shape-memory alloy design, processing, and fatigue characterization.
Direct people-management experience, including hiring and performance management.
Contribution to IDE, PMA, or 510(k) submissions.
Experience through design transfer, pilot production, and process validation.
Prior experience in an early-stage or startup medical device environment.

Responsibilities

Own the program schedule: build and maintain the project plan, define deliverables and owners across functions, and drive the team to committed dates.
Lead the technical design of the implant and delivery system – concept selection, design inputs, materials decisions, prototyping, and design freeze – staying personally hands-on in the day-to-day work.
Run the design control process for the program: design inputs/outputs, risk management, verification and validation planning, design reviews, and design history file ownership.
Drive team-level risk identification through to closure – anticipate failure modes and in vivo device behavior, ensure mitigations are implemented and verified, and keep risk actively managed.
Define the testing and validation strategy – what must be tested, why it matters clinically, and what evidence is required – then develop test methods and coordinate bench, biocompatibility, and preclinical execution across the team, Quality, and external labs.
Coordinate cross-functional execution across Quality, Regulatory, Manufacturing/Operations, and Clinical, escalating risks early and removing roadblocks.
Manage supplier and contract manufacturer relationships – component development, build schedules, and quality expectations.
Serve as the primary technical interface with physician partners and KOLs; convert clinical feedback into design requirements.
Support regulatory strategy and submission content (pre-submissions, IDE and PMA submissions) with the Regulatory function.
Mentor and develop engineers on the program; hire, direct, and guide engineering staff as the team grows.
Prepare and deliver program updates, timelines, and risk assessments to executive leadership and the board of directors.