Job Title: Molding Validation Engineer

Company Name: Biomerics

Location: Salt Lake City, UT

Position Type: Full Time

Pay: DOE

Company Overview: Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team. There is no limit to the impact that can be achieved here at Biomerics. We improve and advance our employees' lives and the lives of the patients that depend on our products.

At Biomerics we believe in integrity, partnership, empowerment & accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-focused corporate culture places a premium on building strategic, mutually beneficial partnerships with customers as well as our team members.

Job Description:

As a Molding Validation Engineer, you will have the opportunity to make a significant impact on the growth, future, and culture of the molding department by acting as Project Manager for projects including mold development, validation, and transfer to production. You will coordinate with Molding Process Engineers in their work developing molding processes, then personally lead the validation activities to transfer a validated molding process to the production team. You will work with R&D engineers in a wide variety of projects from concept to market release. You will often be the primary point of contact with external and internal customers.

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 the scope, time, budget, and resources of projects.
• Coordinating DFM (Design for Manufacturability/Moldability) with other engineers, external vendors, customers, and internal project teams.
• Lead the validation activities to launch new products and molds into production
• Supporting molding Process Engineers by providing project management support through mold design, build, sampling, and validation.
• Managing all molding validation activities, including developing validation plans, writing protocols and reports, coordinating metrology and inspections, and communicating with customers.
• Technical writing of protocols, reports, work instructions, etc.

• A minimum of three (3) 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).
• Strong verbal and written communication skills.
• Proficiency in project management software (e.g., 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).
• 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 are preferred.

Biomerics offers the following benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, 9 Paid Holidays, 401k, Onsite Fitness Facility

The salary estimates are estimates from this job board and not a guarantee from Biomerics salary range.