Manufacturing Engineer II

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 Biomerics' values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and the patients who depend on our products.

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

Job Description

Provide manufacturing support for existing products and develop and introduce new products and equipment.

Responsibilities

• Design and develop manufacturing procedures, tooling, and fixtures that result in sufficient capacity to meet customer demand while promoting product quality, process efficiency, and operator safety.
• Provide production line support, including implementing process improvements, troubleshooting equipment, and addressing operator inquiries.
• Generate and modify manufacturing process documentation. Assure that manufacturing processes and related documentation follow established policies and procedures.
• Utilize LEAN, Six Sigma, and other best practice tools and principles for daily problem-solving and continuous improvement.
• Assist in identifying equipment needs on the production floor and evaluate internal and external options for sourcing such equipment.
• Generate and modify component and assembly drawings using Solid Works.
• Develop and release new products using customer or internal specifications.
• Write and execute process and equipment validations (IQ/OQ/PQ).
• Work with Research and Development, Marketing, Quality, and Manufacturing Departments during the concept, prototyping, and release of new products.
• Work with the Internal Audit team to perform an annual schedule of quality system audits.
• Work with external vendors as needed.
• Perform equipment maintenance by following the manufacturer’s instructions and established procedures.
• Other assignments, as requested.

• A bachelor’s or technical degree in a related engineering field (mechanical or industrial) is preferred, and a minimum of 5+ years’ experience in a medical device manufacturing environment is preferred.
• LEAN manufacturing experience.
• Experience/knowledge with process and equipment validation, PFMEA, IQ/OQ/PQ.
• CAD experience/knowledge.
• Must possess good project management skills and initiative in taking on and completing projects.
• Must possess good verbal and written communication skills.

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.

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

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

Biomerics does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Biomerics approved agency list. Unsolicited resumes or candidate information submitted to Biomerics by search/recruiting agencies not already on Biomerics approved agency list shall become the property of Biomerics. If Biomerics subsequently hires the candidate, Biomerics shall not owe any fee to the submitting agency.