Production Support Engineer

Description

Hey there, production wizards! Ready to jump into the exciting world of medical devices?  Read about us below.

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 the design, development, and production of medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for the 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, 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.

Biomerics is a leading provider of laser processing services and contract manufacturing of medical components and assemblies to a wide range of customers throughout the United States and internationally. The company develops and implements leading-edge part-specific manufacturing processes utilizing such high-tech manufacturing tools as rapid prototyping, automation, PLCs, robotics, and vision systems.

The company offers a uniquely friendly and supportive environment and strongly encourages its employees to learn and grow in their careers. The company offers its eligible employees a range of benefits which include, medical and dental benefits, 401K, and paid time off.

Production Support Engineer: Your Role and Adventure Awaits 

As a Production Support Engineer in the medical devices industry, you’ll be the hero ensuring our manufacturing processes run seamlessly and that our products are top-notch. Here’s a peek into your mission: 

Responsibilities: 

1. Technical Support: Be the on-the-ground problem-solver for production lines.      
2. Process Improvement: Analyze and tweak production processes to boost efficiency and quality. 
3. Quality Assurance: Ensure all products meet regulatory standards and internal quality guidelines. Get involved in audits and inspections. 
4. Documentation: Keep meticulous records of production processes, incidents, and resolutions to stay compliant with regulations. 
5. Collaboration: Work closely with engineering, quality assurance, and manufacturing teams to tackle and resolve challenges. 
6. Training: Help train staff on new processes, equipment, or quality standards.      
7. Root Cause Analysis: Investigate production failures or quality issues, determine root causes, and implement corrective actions. 
8. Equipment Maintenance: Monitor and maintain production equipment, coordinating repairs and preventive maintenance as needed. 

Skills: 

• Technical Proficiency: Know your stuff about manufacturing processes and medical device regulations (e.g., ISO 13485, FDA guidelines). 
• Problem-Solving: Have excellent analytical skills for troubleshooting. 
• Attention to Detail: Document meticulously to ensure compliance and traceability. 
• Communication: Strong verbal and written skills for effective collaboration and documentation. 
• Project Management: Juggle multiple projects and prioritize tasks in a fast-paced environment. 

Requirements

Qualifications: 

• Education: Bachelor’s degree in engineering (mechanical, biomedical, or industrial) or related field. 
• Experience: Prior experience in production support or a related role in the medical device industry is highly beneficial. 
• Certifications