Senior Process 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 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' and patients' lives 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 and our team members.

Job Description

The Senior Process Engineer will be responsible for supporting and improving the manufacturing of class II medical and surgical devices in a dynamic, customer-focused organization. You will be expected to work with customers to understand product and process specifications, develop manufacturing processes, and build and test devices to those specifications. All activities must be documented according to design control requirements in a design history file (DHF).

The Senior Process Engineer may be an individual contributor in a small cross-functional team comprising engineering, operations, and quality members to provide process and manufacturability input to designs throughout the product development process. You will support verification, validation, and regulatory submissions of these devices, then lead the transfer of the products to production and ensure a smooth transition to the production engineering team.

Responsibilities

Develop and improve manufacturing processes for new and existing products.

• Support and troubleshoot equipment, programs, and processes already in production.
• Design machines, tooling, and fixtures for new and existing products.
• Author and execute process validation activities.
• Develop the manufacturing processes and flow to meet product cost targets.
• Provide manufacturability input to product development engineers during the product development process.
• Respond to customer complaints and initiate action to prevent the reoccurrence of non-conformities related to the product, service, processes, or quality system.
• Demonstrating knowledge of project management principles.
• Implement continuous improvement actions in conjunction with the Production Engineering team to ramp up the production of new products to meet customer demand curves and cost targets.
• Lead a team of engineers and/or techs focused on supporting manufacturing.