Principal Mechanical Engineer
3 hours ago
Cirtec Medical Corporation is seeking a highly skilled Principal Mechanical Engineer to join our team. As a Principal Mechanical Engineer, you will be responsible for leading the design and development of complex medical devices, including state-of-the-art minimally invasive catheter-based devices and delivery systems for implants.
You will work closely with cross-functional teams to develop novel medical devices, define requirements, timelines, and deliverables, and ensure the successful launch of products to market. Your expertise in mechanical engineering, design control processes, and regulatory requirements will be essential in driving the development of innovative medical devices.
We are looking for a talented and experienced mechanical engineer who can bring their expertise in design and development to our team. If you are passionate about creating innovative medical devices and have a strong background in mechanical engineering, we encourage you to apply for this exciting opportunity.
Key Responsibilities- Owns the design and development of medical devices through transformation of internal and external inputs into outputs
- Develops design requirements and specifications with mechanical and electrical components and assemblies
- Generates 3D models and engineering drawings utilizing Solidworks
- Performs tolerance analyses to ensure component interactions are understood
- Understands the functional performance of the products as they are developed
- Creates test methods and corresponding test method validations
- Leads dFMEA creation
- Coordinates design verification activities
- Communicates technical risks as they arise
- Performs detailed design reviews and tolerance analyses to achieve product performance, cost, reliability, and manufacturability requirements
- Communicates directly with clients to understand needs and present results
- Effectively interfaces with and manages suppliers to fabricate prototype and final components
- Manages workload to support various projects, in larger scale and complexity
- Mentors other engineers in various functions
- Maintains compliance to procedures and regulatory requirements
- Provides regular status updates to management and/or customer
- Writes/updates work instructions, part specifications, verification protocols, and various technical documents
- Bachelor's degree in Mechanical/Biomedical Engineering or equivalent engineering discipline
- 10+ years of experience within the Medical Device industry; or a combination of education and relevant work experience
- Experience in development of medical devices (i.e. delivery tools, catheters, consoles, surgical tools, etc.) is highly preferred
- Experience in developing test protocols, test methods, executing engineering-level tests, analyzing test data, and developing reports
- Experience in developing test fixtures
- Proficiency with Solidworks required
- Excellent communication skills both written and oral
- Experience and working knowledge of medical device design control processes highly preferred
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