Sr Mechanical Engineer I

About This Role

iRhythm is seeking a Sr Mechanical Engineer I 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

• Tackle technical activities for key development initiatives, including new and sustaining hardware projects (device, packaging, fixtures, and process)
• Apply mechanical and/or materials 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
• 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
• Execute Verification & Validation (V&V) activities including developing new test methods, writing test protocols/reports, and performing failure analysis
• Complete deliverables for regulatory submissions
• Conduct design transfer activities with Manufacturing team to support product launch
• Lead mechanical design of wearable medical devices and tools/fixtures
• Write mechanical sub-system requirements and translate them into product designs and features that deliver high quality data insights
• Generate creative, scalable concepts that leverage thoughtfully chosen material choices to meet the needs of ambulatory, body-worn devices (electro-mechanical sensor-based technologies)
• Utilize SolidWorks CAD to create engineering drawings and SolidWorks PDM to manage CAD models in compliance with ISO 13485 QMS
• Identify, analyze, and mitigate design risks
• Support product packaging through collaboration with internal/external packaging and labeling teams
• Scale products through high-volume manufacturing processes, utilizing experience in injection molding, adhesives, die cutting, and electronics integration
• Support sustaining and second sourcing activities (e.g., supplier selection/qualification)
• Influence business and product decisions using research and data
• 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 collaborate with 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 are detail-oriented, able to juggle competing priorities, and interested in the challenges surrounding medical device production.

Required Qualifications

• Degree in Mechanical Engineering or equivalent technical discipline; BS with 5+ years or MS with 3+ years of relevant experience
• Industry experience in product development, working through the design control process and rigorous V&V test cycles in a highly regulated industry, like medical devices
• Proficient in SolidWorks CAD, SolidWorks PDM, and GD&T
• Experience with design analysis (through empirical methods and finite element analysis), high-volume manufacturing, and injection molding is a plus
• Self-motivated with an ability to work independently
• Demonstrated ability to communicate and collaborate effectively across engineering disciplines (e.g., Electrical, Quality, Manufacturing) and with cross-functional partners (e.g., Regulatory, Product)
• 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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