Plastics Process Engineer

Job Title: Senior Injection Molding Engineer

Company Name: Biomerics

Location: Mebane, NC

Duration: 6+ Months C2H

This is a contract to hire role we need US Citizen / Green Card Holder Only

Company Description:

Biomerics is a rapidly growing, world class contract manufacturer for the medical device and biotech industries. As a vertically integrated company, we specialize in the design, development, and production

of medical devices for diagnostic and interventional procedures. We are committed to the growth and development of our employees. Please explore our website for more information about our offerings and capabilities.

Job Description:

As an Injection Molding Process Engineer you will provide technical expertise in support of existing operations as well as new product development and introduction projects. You will be responsible for

Establish and maintain manufacturing processes and procedures including capacity planning, tooling acquisition and replacement plans, process development using scientific injection molding

techniques, routings, cost reductions, and quality improvements within the organization. A special focus is placed on Injection Molding; new tool specification, acquisition, debugging, decoupled process

development and validation, as well as new or replacement equipment specification and activities. Key metrics for this position include project on time delivery, scrap, machine efficiency, cost reductions

and customer satisfaction.

Roles and Responsibilities Include:

- Establishing project timelines and driving for the successful completion of projects.

- Direct interface with customers, suppliers, and internal resources in a professional manner.

- Defining and managing scope, time, budget, and resources of projects.

- Coordinating DFM (Design for Manufacturability/Moldability) with other engineers, external vendors, customers, and internal project teams.

- Leading the validation activities to launch new products and molds into production including all documentation in accordance with company, FDA, ISO and customer standards.

- Managing all molding validation activities, including developing validation plans, writing protocols and reports, coordinating metrology and inspections, and communicating with customers.

- Submit, review and/or approve change orders to implement new or revise existing processes.

- Train production personnel on new and revised processes.

- Technical writing of protocols, reports, work instructions, etc.

- Any other duties or projects as required.

Requirements:

- A minimum of five (5) years of related work experience (preferably in the medical device field).

- B.S. degree in an engineering or related field or equivalent experience (Plastics, mechanical, manufacturing, or materials preferred).

- Experience developing injection molding processes using Scientific Injection Molding principles.

- Experience specifying and procuring Injection Molding Tooling, Molding Machines and Auxiliary Equipment.

- Strong verbal and written communication skills.

- Proficiency in project management software (eg. MS Project, Smartsheet, Excel, or similar)

- Beginning experience level in SolidWorks.

- Proficiency in Microsoft Office (e.g. Word, Excel, PowerPoint, etc.).

- Must be able to work in a fast-paced environment with little to no supervision.

- Experience with medical process validation, including validation definition and execution (IQ, OQ, PQ), test method definition, root cause analysis, and measurement systems analysis (MSA), pFMEA, dFMEA.

- The ability to perform statistical analysis (DOE, capability, GR&R, etc.) using Minitab software.

- Experience and understanding of the development and design of plastic parts and assemblies preferred.