Process 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.

The Process Engineer is primarily responsible for supporting existing business needs by developing new and improved processes, tooling, and manufacturing concepts, and identifying cost savings projects.  Process Engineers provide training to new operators and provide technical assistance and support to the manufacturing department as necessary.  

KEY ROLE AND RESPONSIBILITIES: 

• Improve manufacturing efficiency, production yields, product quality, and consistency through equipment and product design modifications and fabrication.   
• Modify and improve existing equipment.   
• Complete projects, report status, and document lessons learns efficiently.   
• Utilize project management tools in establishing timelines, building action item lists, assigning responsibility, completing dates, and achieving milestones.   
• Finalizes manufacturing methods for medical devices.   
• Responsible for process validation.   
• Assist with equipment design for producing medical devices and components.   
• Supports production and manufacturing.   
• Analyzes and documents test results for development and pilot production runs.   
• Engineering support which includes vendor contact and auditing specification.   
• Develops and tests components and assemblies of manufacturer’s products.   
• Responsible for manufacturing methods and their transfer into production.   
• Assists in special projects as needed.   
• Contributes to team effort by accomplishing related duties as requested.   
• Follow SOP on re-validation of existing equipment, tooling, and processes.   
• Develops/improved processes, sampling activities, and as well as tooling and manufacturing concepts that will meet customer expectations on cost, quality, and delivery.   
• Provide technical assistance and engineering support to the manufacturing floor in ensuring the production of quality products.  Work with other support departments to maintain on-time delivery goals.   
• Lead process improvement and waste elimination efforts through the application of lean principles and actively participate in continuous improvement events.   
• Works with Quality Control team to generate, update and implement all project-related documentation including control plans, work instructions, manufacturing procedures, sample requests, process guides, and troubleshooting guides.   
• Other duties as assigned by the Operations Manager  
• Demonstrates all the Flexan’ s corporate values   
  • We have an engaged culture   
  • We embrace the rigor to be safety and quality driven in all we do   
  • We embrace the choice to work here   
  • We operate with transparency, ethics, and integrity   
  • We consistently meet our expectations   

Minimum Qualifications: 

• BS in Engineering or a similar related field 
• 2 years of experience 
• Hands-on extrusion or molding experience 
• Strong understanding of dFMEA
• Understanding of the validation process
• Demonstrated analytical and problem-solving skills. 
• Experience in new product development, introduction processes, and procurement protocols.
• Must have advanced skills in Microsoft Word, Excel, PowerPoint, and Minitab (or other statistical analysis software).  SolidWorks or CAD modeling software is a plus 

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.