Description* Please note - Sponsorship is not available for this rolePosition 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.
