Process Engineer II

Biomerics; Utah; On-site; USD 70,000 - 90,000; Full time

Job summary

Biomerics is seeking a Process Engineer II in Salt Lake City to drive continuous improvement and develop robust manufacturing processes for medical devices. You will design fixtures, conduct time studies, and collaborate with design teams to ensure manufacturability, while upholding regulatory validation standards.

The role requires 2–4 years in manufacturing or medical devices and SolidWorks proficiency. You will mentor engineers and technicians, lead root cause analyses, and deliver

Qualifications

• Bachelor’s degree in Engineering is required.
• 2–4 years in manufacturing or medical device industry preferred.
• Experience with process validation and regulatory standards preferred.
• CAD skills with SolidWorks preferred.
• Strong statistical analysis and root cause analysis capabilities required.

Responsibilities

• Drive continuous improvement initiatives to optimize processes and reduce costs.
• Develop, implement and refine manufacturing processes for new and existing products.
• Design and build production fixtures using CAD tools to improve consistency and throughput.
• Conduct time studies and map processes to identify bottlenecks and improvements.
• Troubleshoot equipment, programs, and processes in production.
• Lead design improvements to machines, tooling, and fixtures for efficiency and quality.
• Execute IQ/OQ/PQ process validation in line with regulatory standards.
• Collaborate with product development teams for manufacturability (DFMA).
• Lead structured problem-solving using root cause analysis and statistical tools.
• Respond to customer complaints and implement corrective and preventive actions.
• Apply project management principles to deliver improvements on time.
• Mentor and lead engineers and technicians in manufacturing operations.

Skills

Statistical analysis

Root cause analysis

Project leadership

Manufacturing processes

Documentation

Education

Bachelor’s degree in Engineering

Tools

SolidWorks

Job description

Process Engineer II

Salt Lake City

Full-time

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. There is no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and patients who 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.

Responsibilities

• Drive continuous improvement initiatives to optimize processes, reduce costs, and meet customer requirements.
• Develop, implement, and refine manufacturing processes for new and existing products.
• Design and build production fixtures using CAD tools to enhance consistency, reduce quality issues, and improve operational efficiency.
• Conduct time studies and create process flow maps to identify bottlenecks and implement improvements that drive efficiency and throughput.
• Troubleshoot and resolve issues with equipment, programs, and processes in production.
• Design and improve machines, tooling, and fixtures to enhance efficiency and quality.
• Author and execute process validation activities (IQ, OQ, PQ) in compliance with regulatory standards.
• Collaborate with product development teams to ensure designs are optimized for manufacturability and assembly (DFMA).
• Lead structured problem‑solving efforts using root cause analysis and statistical tools to prevent recurrence of non‑conformities.
• Respond to customer complaints and implement corrective and preventive actions.
• Apply project management principles to deliver improvements on time and within scope.
• Mentor and lead engineers and technicians in supporting manufacturing operations and improvement projects.

Requirements

• Education: Bachelor’s degree in Engineering (required).
• Experience: 2--4 years in manufacturing or medical device industry (medical device experience preferred).
• Ability to work independently and influence teams toward achieving business objectives.
• Experience across the medical device lifecycle, including design verification, process validation, and technology transfer (preferred).
• Six Sigma Green/Black Belt certification (preferred).
• Proficiency in statistical analysis (e.g., k-factors, Ppk, DOE) and root cause analysis.
• Skilled in CAD software (SolidWorks preferred).
• Strong knowledge of process validation (IQ, OQ, PQ), test method validation, measurement systems analysis (MSA), and structured problem‑solving.
• Ability to write clear, operator-friendly manufacturing work instructions.
• Leadership experience in guiding engineers and technicians in manufacturing support.