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Senior Mechanical Engineer, Medical Devices
$129k-156k (estimate)
Full Time | IT Outsourcing & Consulting
2 Months Ago
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AliveCor is Hiring a Senior Mechanical Engineer, Medical Devices Near Mountain View, CA
Senior Mechanical Engineer, Medical Devices
Why join AliveCor
At AliveCor, we imagine a healthier world powered by access to personalized intelligent information. We're on a mission to be the world’s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical ECG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, millions of users have taken more than 200 million heart health measurements and counting. Our vibrant team of people are attracted to AliveCor because they want to build something meaningful -- and AliveCor delivers: every day, customers tell us that we’ve saved lives. Join us in our mission!
The Opportunity:
We are seeking a highly skilled Senior Mechanical Engineer with expertise in plastic and metal design, materials science, extensive experience in the medical device industry, proficiency in process/manufacturing engineering and product test engineering, a well-rounded knowledge of basic electrical engineering principles, and a basic understanding of firmware concepts. The ideal candidate will possess a deep understanding of medical device 60601 standards and regulations, coupled with a well-rounded knowledge of electrical and firmware engineering concepts.
Note: The pay range listed for this posting may vary depending on experience and location.
Pay range: $125,000-$140,000
Location: Mountain View Office. This is an On-site position only, the employee will be expected to come to the office each day.
Responsibilities:
- Lead the design and development of mechanical components and systems for medical devices, including creation and maintenance of all BOMs, drawings, and documentation, ensuring compliance with industry standards and regulations, particularly IEC 60601 standards and manufacturing to ISO 13485.
- Collaborate with cross-functional teams including electrical engineers, firmware engineers, product and operations teams, quality and regulatory teams, and marketing to bring innovative medical devices from concept to market.
- Utilize advanced knowledge of materials science to select appropriate materials for product design, considering factors such as biocompatibility, durability, and manufacturability (DFM).
- Conduct feasibility studies, risk assessments, and design verification activities to ensure product performance and safety.
- Work closely with contract manufacturers to optimize manufacturing processes, improve yield, and ensure product quality and consistency.
- Apply strong knowledge of manufacturing processes including injection molding, 3D printing, progressive metal bending dies, heat staking, use of pressure sensitive adhesives (PSAs), adhesives, silicones, and ultrasonic welding to optimize product design for manufacturability (DFM).
- Conduct finite element analysis (FEA) or stress analysis using software tools to evaluate and optimize mechanical designs for performance and reliability.
- Develop and implement manufacturing strategies that align with product requirements, cost targets, and scalability objectives.
- Collaborate with systems, electrical, and firmware engineers to understand basic electrical and firmware requirements and interface mechanical systems with electronic components.
- Assist in the preparation of medical device paperwork for compliance with regulatory requirements, including FDA submissions and any other required internal or external documentation.
- Aid engineering teams wherever necessary, including design reviews, troubleshooting, sustaining engineering, and resolution of technical challenges.
Qualifications & Skills:
- Bachelor's degree in Mechanical Engineering. Master's degree preferred.
- Minimum of 5 years of experience in mechanical design and development within the medical device industry.
- Proficiency in SolidWorks for 3D modeling and simulation.
- Strong understanding of materials selection, properties, and manufacturing processes for both plastic and metal components.
- In-depth knowledge of regulatory standards and guidelines, particularly IEC 60601 series for medical electrical equipment.
- Basic understanding of electrical/firmware concepts and ability to collaborate effectively with systems, electrical, and firmware engineers and ability to read and understand datasheets for EE components or firmware register values.
- Experience in basic electrical engineering concepts, including basic circuit analysis, board rework/soldering, and basic debug using DMM/oscilloscope.
- Demonstrated expertise in process/manufacturing engineering and DFM, with experience working collaboratively with contract manufacturers.
- Excellent communication skills with the ability to effectively collaborate with multidisciplinary teams and communicate/articulate technical concepts to technical and non-technical stakeholders.
- Proven track record of successful product development projects from concept to commercialization - must understand the whole product design life cycle and be comfortable with each stage.
- Ability to work independently, prioritize tasks, and meet project deadlines in a fast-paced environment. Strong project management skills.
AliveCor is an equal opportunity employer and will not discriminate against any employee or applicant based on age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any other classification protected by federal, state, or local law.
Principals only. Recruiters, please don’t contact this job poster. Do not contact us with unsolicited services or offers.
Job Summary
JOB TYPE
Full Time
INDUSTRY
IT Outsourcing & Consulting
SALARY
$129k-156k (estimate)
POST DATE
02/29/2024
EXPIRATION DATE
03/27/2024
WEBSITE
alivecor.com
HEADQUARTERS
OKLAHOMA CITY, OK
SIZE
100 - 200
FOUNDED
2010
TYPE
Private
REVENUE
<$5M
INDUSTRY
IT Outsourcing & Consulting
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About AliveCor
AliveCor designs and develops AI-enabled ECG devices that offers heart rate monitoring and tracking solutions to patients.
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