Staff Mechanical R&D Engineer

About This Role

iRhythm is seeking a Staff Mechanical R&D Engineer to join our Product Development team. The Product Development team is made up of a close-knit group of talented engineers representing a wide range of engineering disciplines. This position is a hybrid role that will require you to be on-site in our San Francisco, California office, with flexibility for days of remote work as appropriate.

In this role, you will contribute directly to the development of wearable medical products, spanning early-stage research through commercialization. Our work environment is highly collaborative, and engineers at iRhythm work passionately to deliver innovative solutions that improve the quality of healthcare and the patient experience. We are looking for like-minded individuals to join our team!

Responsibilities

• Drive mechanical team activities through the entire new product introduction (NPI) process
  • Support early-stage research by ideating, testing, and iterating on new concepts and processes to advance product innovation
  • Lead Verification & Validation (V&V) by defining test strategy, developing new test methods, and writing test protocols/reports
  • Understand requirements for regulatory submissions, and identify, analyze, and mitigate risks
  • Manage design transfer activities with Manufacturing team to support product launch
• Assess and prioritize technical activities for key development initiatives and early-stage feasibility work
• Translate clinical needs to engineering requirements and conversely, communicate technical concepts to non-technical people
• Identify and evaluate promising technologies for incorporation into wearable sensing solutions
• Analyze and interpret data through various techniques using Python or R
• Serve as subject matter expert in materials, biomechanics, and DOE (Design of Experim
• ents)
• Lead mechanical design of wearable medical devices and tools/fixtures
  • Develop highly user-focused designs that deliver high quality and reliable data insights (electro-mechanical sensor-based technologies)
  • Generate creative, scalable concepts that leverage thoughtfully chosen material choices that meet the needs of ambulatory, body-worn devices.
  • Utilize SolidWorks CAD to create engineering drawings (GD&T) and SolidWorks PDM to manage CAD models in compliance with ISO 13485 QMS.
  • Support product packaging through collaboration with internal/external packaging and labeling teams
• Influence business and product decisions using research and data
• Apply technical expertise to aid in failure analysis for discrepant production components, assemblies, and field complaints
• Manage supplier and contract manufacturer relationships including driving schedules, making design changes based on DFM input, approving first articles, and troubleshooting issues
• Support sustaining and second sourcing activities (e.g., supplier selection/qualification)
• Contribute to generation of intellectual property
  
  

About You:

You are interested in the intersection of technology and medicine and the evolving world of wearable sensors and digital health. As a versatile and well-rounded engineer, you can just as easily lead a cross-functional team to meet project milestones as roll up your sleeves for hands-on prototyping in the lab. You are a critical thinker who enjoys working on complex problems and feels comfortable exercising independent judgment. You must be able to juggle competing priorities and may supervise the activities of others.

Required Qualifications

• Degree in Mechanical Engineering, Biomedical Engineering, Materials Science Engineering, or similar discipline. PhD with 5+ years, MS with 8+ years, or BS with 10+ years of relevant experience in medical devices.
• Industry experience leading or contributing to product development through the design control process and rigorous V&V test cycles in a highly regulated industry like medical devices
• Strong grasp of complex, hypothesis-driven experimental design
• Expertise in materials (e.g., adhesives, plastics, metals) and/or the relevant biomechanics of ambulatory, body-worn devices and the skin
• Familiarity with physiological parameters and sensing (e.g. ECG, pulse oximetry, blood pressure)
• Self-motivated with an ability to work independently and to direct/manage the work of others as needed
• Demonstrated ability to communicate and collaborate effectively across engineering disciplines (e.g., Electrical, Quality, Manufacturing) and with cross-functional partners (e.g., Regulatory, Clinical Research)
• Values and prioritizes a supportive team environment that enables open-minded and respectful discussion
• Able to travel to Manufacturing facility (Cypress, CA) or vendors as required, up to 10%
  
  

What's In It For You

This is a regular full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurances (all of which start on your first day), health savings account employer contributions (when enrolled in high deductible medical plan), cafeteria plan pre-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts), travel reimbursement for medical care, noncontributory basic life insurance & short/ long term disability. Additionally, we offer:

• emotional health support for you and your loved ones
• legal / financial / identity theft/ pet and child referral assistance
• paid parental leave, paid holidays, travel assistance for personal trips and PTO!

iRhythm also provides additional benefits including 401(k) (with company match), an Employee Stock Purchase Plan, pet insurance discount, unlimited amount of Linked In Learning classes and so much more! 

FLSA Status: Exempt

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