Engineering Manager, R&D

Caldera Medical•Westlake Village, CA

19h•Onsite

About The Position

Caldera Medical’s Mission - To Improve the Quality of Life for Women! Message from the Hiring Manager: Caldera Medical is scaling its R&D organization to accelerate new product development, sustain existing product lines, and strengthen engineering execution across the portfolio. This Engineering Manager will lead a team of design, development, and sustaining engineers to deliver on the product roadmap while ensuring compliance with FDA and international regulatory requirements. The role is critical to maintaining Caldera's competitive advantage in pelvic floor therapies and supporting expansion into adjacent women's health categories.

Requirements

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related discipline (Master's preferred)
8+ years of progressive engineering experience in the medical device industry, with at least 3 years in a people management role
Direct experience with Class II or Class III medical devices through full product development lifecycle (concept to market)
Working knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and EU MDR
Experience managing engineering budgets and vendor relationships
Strong proficiency in CAD (SolidWorks preferred), PLM systems, and engineering documentation practices
20% Travel expected

Nice To Haves

Leadership & People Development: Proven ability to build, motivate, and develop engineering teams in a fast paced, resource constrained environment
Technical Depth in Medical Devices: Strong working knowledge of design controls, risk management (ISO 14971), biocompatibility, and manufacturing process validation
Project & Portfolio Management: Demonstrated skill managing multiple concurrent development programs with competing priorities
Cross Functional Collaboration: Track record of effective partnership with Quality, Regulatory, Operations, and Commercial stakeholders
Problem Solving & Decision Making: Ability to diagnose root causes, make sound technical decisions under uncertainty, and drive issues to closure
Communication: Clear, concise communicator who can translate complex engineering topics for executive and non technical audiences

Responsibilities

Lead and manage a team of R&D engineers through all phases of product development from concept through commercialization
Own the engineering project portfolio: set priorities, allocate resources, manage timelines, and ensure deliverables meet quality and regulatory standards
Drive design control processes in accordance with FDA 21 CFR 820, ISO 13485, and EU MDR requirements
Partner cross functionally with Quality, Regulatory, Operations, and Commercial teams to ensure seamless product launches
Develop and mentor engineering talent; build a high performance team culture aligned with Caldera's mission and values
Manage engineering budgets, capital expenditures, and vendor/contractor relationships
Support sustaining engineering activities including CAPAs, design changes, and supplier qualifications
Present project status risks and resource needs to executive leadership on a regular cadence