Senior Process Engineer

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 focus on next-generation solutions for the vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets. Our team-oriented, customer-focused culture values integrity, partnership, empowerment, accountability, trust, agility, teamwork, excellence, and care.

About the role

The Senior Process Engineer will support and improve the manufacturing of class II medical and surgical devices in a dynamic, customer-focused organization. You will collaborate 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). You may serve as an individual contributor in a small cross-functional team comprising engineering, operations, and quality members to provide process and manufacturability input throughout the product development process. The role includes supporting verification, validation, and regulatory submissions, leading the transfer of products to production, and ensuring 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 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.
• Demonstrate knowledge of project management principles.
• Implement continuous improvement actions in conjunction with the Production Engineering team to ramp up production of new products to meet customer demand curves and cost targets.
• Lead a team of engineers and/or technicians focused on supporting manufacturing.
• Write manufacturing work instructions that operators can follow.

Requirements

• MS in Engineering or other relevant discipline + 3 years’ experience, or BS in Engineering or other relevant discipline + 5 years’ experience (preferably in the medical device field or manufacturing industry).
• Ability to influence a team toward business objectives.
• Ability to function with little or no supervision.
• Experience working through all aspects of medical device design & development, including design verification and validation, process validation, and technology transfer (preferred).
• Six Sigma Green/Black Belt (preferred).
• Ability to perform statistical analysis using k-factors, Ppk, DOEs, and root cause analysis (preferred).
• Proficiency in solid 3-D modeling (e.g., SolidWorks) (preferred).
• Design for manufacturability and assembly (DFMA) (preferred).
• Proficient with medical process validation, including IQ, OQ, PQ, test method definition, root cause analysis, test method validations, measurement systems analysis (MSA), and structured problem solving.

Benefits

• Medical, dental, and vision insurance
• Short-term and long-term disability
• Life insurance
• Paid vacation days and holidays
• 401k
• On-site fitness facility