This position will be responsible for coordinating and executing new product development according to customer specifications, developing hands-on product solutions and supporting the business development cycle for Nextern.
The R&D Engineer aids in managing a complete device project from the early concept, through Nextern's detailed phase gate development, and through product manufacturing/commercialization.
This includes responsibility for release of specifications, determination of best manufacturing methods, ensuring that the product meets specifications, and executing the documentation associated with these activities.
The R&D Engineer will work closely with supplier management, quality, and operations to execute these responsibilities.
DUTIES AND RESPONSIBILITIES:
- Coordinates new product development with customers and internal project teams
- Review high level design requirements to evaluate whether they are within Nextern core competency and vision
- Review design and determine required Bill of Materials
- Take high-level product requirements and translate into a design(s) that is manufacturable and meets or exceeds the requirements.
- Work with CAD designers to complete drawings of components and assemblies.
- Work with supply chain to obtain BOM pricing (from internal and external vendors)
- Assist with development of proposals and costs models for review by management
- Generate required documentation in support of the development and manufacturing products and processes, including timelines, responsibilities, engineering protocols, bill of materials, assembling instructions, manufacturing instructions and procedures.
- Assist in component and device testing protocols, execution of the testing, and writing of test reports.
- Assist in development of plans to evaluate process repeatability and stability through equipment qualification and process validation.
- Work with quality, supply chain and PD to ensure compliance with QSR and internal protocols.
- Provides support in the resolution of product complaints and/or safety issues.
- Works with various departments to facilitate pilot production of new products.
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA/QSR regulations.
- Transfer as required engineering project from engineering into manufacturing.
- Performs other related duties as assigned by management.
**Requirements**:
- Bachelor's degree in engineering and three to five years of related experience, or equivalent combination of education and experience.
- Commitment to excellence and high standards
- Excellent written and oral communication skills in both English and Spanish
- Strong organizational, problem-solving, and analytical skills
- Ability to manage priorities and workflow
- Demonstrated ability to plan and organize projects
- Good judgement with the ability to make timely and sound decisions
- Creative, flexible, and innovative team player
- Working knowledge of data collection, data analysis, evaluation, and scientific method.
- Working knowledge and understanding of the basic principles, theories, concepts, and practices in the applicable area of engineering/technical specialization.
**Benefits**
Competitive compensation package and very attractive working conditions.