Senior R&D Engineer - Sustaining Engineer

EBR Systems, Inc.; Sunnyvale (CA); On-site; USD 126,000 - 221,000; Full time

Job summary

An innovative company in Silicon Valley is seeking a dedicated R&D professional to resolve development and manufacturing issues for medical products. This role involves supporting new product introductions, managing design changes, and ensuring compliance with regulatory standards. You will collaborate with cross-functional teams to enhance product quality and efficiency. If you're passionate about advancing healthcare technology and thrive in a fast-paced environment, this opportunity offers a chance to make a significant impact on patient care through groundbreaking solutions.

Benefits

Medical, dental, and vision insurance

401K Matching Plan

PTO – starting at 3 weeks per year

Competitive salary with opportunities for career growth

Employee stock options

401(k) Bonus Program

Life and AD&D Insurance

Weekly company lunches

Occasional happy hour events

Meaningful work!

Qualifications

• 5-8+ years in FDA regulated medical product development environments.
• Experience managing multiple time-sensitive projects.

Responsibilities

• Develop project plans and timelines for product design changes.
• Perform verification and validation of design changes.

Skills

Project Management

Risk Management

Root Cause Analysis

Statistical Methods

Interpersonal Skills

Communication Skills

Organizational Skills

Education

Bachelor's degree in Electrical Engineering

Equivalent combination of relevant coursework and job-related experience

Tools

ISO 14971

ISO 14385

Job description

Description

This role provides a dedicated R&D resource to resolve development and manufacturing issues on pre-market and post-market products. This role also supports new product introduction, manufacturing transfer, and R&D product design and design history file (DHF) knowledge transfer. This role supports changes that arise from manufacturing changes (e.g., material, process, etc.), quality issues (e.g., CAPAs, complaints, NCRs, bugs, etc.), regulations update (e.g., standards update, MDR, etc.), and product DHF maintenance (e.g., DHF documents updates due to various sources).

Essential Duties and Responsibilities

• Develop project plans, timelines, milestones for product design changes originating from Operations.
• Perform verification and validation of design changes. Perform risk management in accordance with ISO 14971.
• Document design changes and design transfer within the design history file and execute product development according to pertinent regulatory requirements (e.g., QSR, ISO 14385).
• As needed, serve as the primary investigator of device failures or unexpected behaviors observed on returned product.
• Serve as the planner and subject matter expert for new product introduction, manufacturing transfer, and sustaining product(s) through product lifecycle(s).
• Collaborate closely with production, supply chain, and manufacturing functions to establish priorities for increased quality, throughput, and scalability.
• Develop clinical rationales for specification revisions required for any transferred products.
• Collaborate with Quality and Operations teams to close NCR and CAPA investigations related to transferred products.

Other Duties and Responsibilities

• Other duties as assigned.

Education and Required Experience

• Bachelor’s degree in electrical, software engineering or equivalent combination of relevant coursework and job-related experience.
• Experience with managing multiple time-sensitive projects simultaneously and managing project priorities (important/urgent).
• 5 - 8+ years of experience in FDA regulated medical product development environments.

Knowledge, Skills, and Abilities

• Strong foundation in education, skills in electrical and software engineering and tools for a thorough technical analysis of product failures.
• Expert in tools and processes for root cause analysis.
• Application of statistical methods in manufacturing and product development.
• Understand medical implantable, equipment, and disposable standards and manage standards testing. Requires managing external suppliers to perform a variety of standards testing.
• Create project list dashboards that shares status to all stakeholders.
• Proven knowledge of development, manufacturing, and quality system requirements for medical devices.
• Strong interpersonal, communication (verbal and written), organizational and project management, time management skills.

Physical Requirements:

• Required to stand, walk and sit; talk or hear; use hands to finger, handle or feel objects or controls; reach with hands and arms. Required to stoop, kneel, bend, crouch and lift up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, color vision and the ability to adjust focus.
• Subject to extended periods of sitting and/or standing, vision to monitor, and moderate noise levels.

Disclaimer: EBR Systems Inc. will never ask for personal identifying information (such as Social Security Number, bank account details, or credit card information) during the application process. All communication from EBR Systems Inc. regarding job opportunities will be conducted through official company channels.

EBR Systems, Inc. is an Equal Opportunity Employer committed to a diverse, inclusive, and equitable workplace.

Salary Range

$126,000 - $220,200*

*Base pay is one part of your total compensation. The salary offered will depend on several factors, including, but not limited to your experience, knowledge, skills, location, internal equity, and market alignment. Additional compensation may include bonuses and equity, along with a comprehensive benefits package.

The final starting salary offer to the successful candidate will be determined by evaluating several factors, but not limited to experience, knowledge, skills, internal equity, and alignment with market data.

EBR Systems, Inc. does not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services. Please refrain from solicitations at this time.

Company Overview

Silicon Valley-based EBR Systems is dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing. The company’s patented proprietary Wireless Stimulation Endocardially (WiSE) technology was developed to eliminate the need for cardiac pacing leads, historically the major source of complications and reliability issues in cardiac rhythm disease management.

We are a team of dedicated individuals, driven to deliver superior treatment of millions of patients suffering from cardiac rhythm diseases by developing safe, clinically superior, cost-effective, and reliable therapies using wireless cardiac stimulation. As a fast-paced company, every team member at EBR makes a big contribution towards our mission. We seek candidates who are passionate about improving #healthcare and motivated to do the hard and exciting work required to bring ground-breaking technology to market.

EBR Systems offers a great place to work as well as generous benefits and growth opportunities:

• Medical, dental, and vision insurance
• 401K Matching Plan
• PTO – starting at 3 weeks per year
• Competitive salary with opportunities for career growth
• Employee stock options
• 401(k) Bonus Program
• Life and AD&D Insurance
• Weekly company lunches and occasional happy hour events
• Meaningful work!