CM
Mechanical Engineer I (Catheters)
Accepting applicationsCirtec Medical · Santa Clara, CA
Full-Time Mid
Posted
20h ago
Category
Verification
Experience
Mid
Country
United States
Description
Please note - Sponsorship is not available for this role
About Us
For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.
Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!
Position Summary
The Mechanical Engineer I is primarily responsible for defining, designing, and developing medical devices (catheters) and related accessories. This person will own efforts in developing solutions to product design, and design for manufacturability, translating requirements from the customer into realized products. Able to multitask and run multiple projects while meeting customer commitments.
Key Responsibilities
Owns the design and development of medical devices through:
Transformation of internal and external inputs into outputs
Developing design requirements and specifications with mechanical and electrical components and assemblies
Creating test methods and corresponding test method validations
Leading dFMEA creation
Coordinating design verification activities
Generating 3D models and engineering drawings utilizing Solidworks
Performing tolerance analyses to ensure component interactions are understood
Understanding the functional performance of the products as they are developed
Communicating technical risks as they arise
Host design reviews with internal and external stakeholders
Manage workload to support various projects, in small to medium scale and complexity
Mentorship of other engineers in various functions
Maintain compliance to procedures and regulatory requirements
Good understanding of the product development process within the medical device industry
Provides regular status updates to management and or customer
Writes/updates work instructions, part specifications, verification protocols, and various technical documents
Reliable, consistent, and punctual attendance is an essential function of the job
This is not a remote position.
An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
Must Have
A Bachelor’s degree (STEM engineering discipline) required
FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485)
Proficiency with Solidworks required
Knowledge of dimensioning and tolerances, GD&T
Computer skills associated with Microsoft software
Must be able to read, write and speak fluent English
Excellent reading, writing, communication, and organizational skills
Maintains performance with changing priorities under supervision
Possess team collaboration skills
Strong mechanical aptitude
The pay range for this role is $80,000 - $93,000 a year. The successful candidate’s starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions.
Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.
We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec’s goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.
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Please note - Sponsorship is not available for this role
About Us
For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.
Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!
Position Summary
The Mechanical Engineer I is primarily responsible for defining, designing, and developing medical devices (catheters) and related accessories. This person will own efforts in developing solutions to product design, and design for manufacturability, translating requirements from the customer into realized products. Able to multitask and run multiple projects while meeting customer commitments.
Key Responsibilities
Owns the design and development of medical devices through:
Transformation of internal and external inputs into outputs
Developing design requirements and specifications with mechanical and electrical components and assemblies
Creating test methods and corresponding test method validations
Leading dFMEA creation
Coordinating design verification activities
Generating 3D models and engineering drawings utilizing Solidworks
Performing tolerance analyses to ensure component interactions are understood
Understanding the functional performance of the products as they are developed
Communicating technical risks as they arise
Host design reviews with internal and external stakeholders
Manage workload to support various projects, in small to medium scale and complexity
Mentorship of other engineers in various functions
Maintain compliance to procedures and regulatory requirements
Good understanding of the product development process within the medical device industry
Provides regular status updates to management and or customer
Writes/updates work instructions, part specifications, verification protocols, and various technical documents
Reliable, consistent, and punctual attendance is an essential function of the job
This is not a remote position.
An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
Must Have
A Bachelor’s degree (STEM engineering discipline) required
FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485)
Proficiency with Solidworks required
Knowledge of dimensioning and tolerances, GD&T
Computer skills associated with Microsoft software
Must be able to read, write and speak fluent English
Excellent reading, writing, communication, and organizational skills
Maintains performance with changing priorities under supervision
Possess team collaboration skills
Strong mechanical aptitude
The pay range for this role is $80,000 - $93,000 a year. The successful candidate’s starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions.
Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.
We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec’s goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.
Show more Show less