NPI Engineer
Flexan is a global strategic contract manufacturer of custom high-quality silicone and thermoplastic components, sub-assemblies and devices designed to meet the critical requirements of Class I, Class II and Class III medical devices, as well as custom compounding and molding for precision parts.
As an NPI Engineer, you will apply your engineering and measurement knowledge to a variety of focused hands-on projects. You will be part of an instrumental product development team that designs, develops, and tests products and equipment.
KEY ROLE AND RESPONSIBILITIES:
Coordinates with R&D New Products Development groups to develop strategies for new products.
Provides engineering support for all activities in the product development process.
Prepares project timelines and identifies all resources requirement and evaluates financials for manufacturing processes.
Monitors the status of all new products and ensures effective execution of projects according to required policies, procedures, and government regulations.
Prepares plans for all NPI projects and coordinates with all stakeholders and ensures good quality products.
Coordinates with engineering and product management departments and develops and implements Manufacturing plans for products.
Assists Manufacturing departments and manages communication across all departments.
Develops product test plans and perform production tests according to manufacturing process instructions.
Administers efficient first-release products for D&D for submission to regulatory.
Assists New Product Introduction Manager and manages the integration of all products according to product lifecycle.
Monitors operations of product and evaluates designs and ensures adherence to all design and manufacture principles.
Ensures compliance with all ECO procedures and work instructions.
Works with design engineering and assists in the transition of design prototypes into cost-efficient and high-volume products.
Provides technical support to the Materials Management team for all RFP initiatives and administers effective use of outsourcing products.
Develops prototype design according to required techniques and manufacturing processes.
Maintains an inventory and ensures the availability of required equipment, tools, test equipment, and prototype parts.
Analyze and recommends improvements to all production processes and methods to facilitate cost reduction and quality improvements.
Design new manufacturing process requirements and associate guidelines.
Develop and implement efficient material handling, and flow strategies, and always maintain safe manufacturing processes.
Analyze and recommend corrective action in case of any design failure.
Coordinates with senior management and maintains knowledge of product status and prepares appropriate reports
Perform miscellaneous related duties and other duties as assigned
Minimum Qualifications:
3 to 5 years of engineering experience
Bachelor’s degree in Engineering
Injection molding experience
Medical device experience preferred
It is the policy of Flexan, LLC to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Flexan will provide reasonable accommodations for qualified individuals with disabilities.