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 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: This position will be responsible for completion of preventive maintenance work orders, ensuring equipment is kept clean and in good repair, troubleshooting and resolving equipment problems, implementing new equipment, assisting Engineers with validation protocol writing/execution/report writing, implementing cost improvement ideas, implementing process improvement ideas, performing test runs, documenting test run results, training operators on production processes and other activities associated with the manufacturing of medical devices.

Roles and Responsibilities Include:

• Minimize downtime by troubleshooting and resolving/repairing equipment, tooling, and fixtures problems in a timely manner.
• Perform planned preventative maintenance.
• Train operators on production processes.
• Install equipment (IQ).
• Assist with the development and implementation of Quality Procedures, Standard Operating Procedures (SOPs), Work Instructions, and other manufacturing-related documentation.
• Place orders for tooling, equipment, and fixturing needed to maintain production.
• Proficiency in personal computer software (Microsoft Office).
• CAD modeling and drafting using Solid Works (preferred).
• Ability to work in a team environment.
• Setup fixtures/machines to support production
• Good communication skills (written/verbal).
• Basic math/statistics skills.
• Ability to collect, record and report data accurately.
• Design tooling and fixtures for existing and new manufacturing lines.
• Run studies per the protocol and gather test results for reporting purposes.
• Partner with engineers to implement process and cost-improvement initiatives.
• Creating product labels and troubleshooting printers
• Perform all work within ISO 13485 and 9001:2000 regulated work environment.
• Additional tasks as assigned. Requirements

Job Qualifications:

• It is preferred to have an Associate's degree or two (2) year degree in a technical field or three (3) years of maintenance or engineering technician experience, preferably in medical device manufacturing and assembly, however in lieu of degree experience will be taken into consideration. 
• Complete hands-on tasks, up to and including building fixtures and production runs.
• Ability to execute simple projects without supervision.
• Proven ability to function in a fast-paced, dynamic environment. 
• Familiarity with ISO 13485 and 9001:2000 requirements
• Excellent verbal and written communication skills
• Meticulous record-keeping capability
• Excellent prioritization and organizational skills to manage multiple responsibilities with little to no supervision
• High level of initiative and flexibility in adapting to changing needs of a dynamic work environment
• Proficiency with Outlook, Word, PowerPoint, and Excel

Non-required but Preferred Qualifications:

• Experience in a cleanroom manufacturing environment.
• Proficient with SolidWorks. 

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

Please, No Recruitment Agency calls or emails (we are not using recruitment services for this, or any other role posted)