Senior Manufacturing Engineer

JOB DESCRIPTION

JOB TITLE: Senior Manufacturing Engineer

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' and patients' lives 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 and our team members.

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

JOB REQUIREMENTS:

1. 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.
2. Provide production line support, including but not limited to implementing process improvements, troubleshooting equipment, and addressing operator inquiries.
3. Generate and modify manufacturing process documentation. Assure that manufacturing processes and related documentation follow established policies and procedures.
4. Utilize LEAN, Six Sigma, and other best practice tools and principles for day-to-day problem-solving and continuous improvement.
5. Assist in identifying equipment needs on the production floor and evaluate internal and external sourcing options.
6. Generate and modify component and assembly drawings using Solid Works.
7. Develop and release new products using customer or internal specifications.
8. Write and execute process and equipment validations (IQ/OQ/PQ).
9. Work with Research and Development, Marketing, Quality, and Manufacturing Departments during the concept, prototyping, and release of new products.
10. Work with the Internal Audit team to perform an annual schedule of quality system audits.
11. Work with external vendors as needed.
12. Perform equipment maintenance by following the manufacturer’s instructions and established procedures.
13. Other assignments as requested.

Requirements:

1. Bachelor’s or Technical Degree in a related engineering field (Mechanical or Industrial) preferred or minimum 5+ years’ experience in a medical device manufacturing environment.
2. Possess a broad, in-depth knowledge of manufacturing processes and systems and can apply them appropriately.
3. Work independently and develop manufacturing systems, including processes, tooling, automation, and controls.
4. Ability to effectively execute high-level engineering tasks, including planning, scheduling, and leading major cross-functional technical projects in a complex manner.
5. Intuitively identifies technical risks and proactively reduces the negative impact on products and projects.
6. Effectively guide junior Engineers and technical personnel.
7. LEAN manufacturing experience.
8. Experience/knowledge with process and equipment validation, PFMEA, IQ/OQ/PQ.
9. CAD experience/knowledge.
10. Must possess good project management skills and initiative in taking on and completing projects.
11. Must possess good verbal and written communication skills.

Benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401k, On-site fitness facility