Manufacturing Engineer II / III – Polymeric Heart Valves

Role details

Manufacturing Engineer II / III – Polymeric Heart Valves

Location: Salt Lake City, UT

Employment Type: Full-Time

Pay: $90,000.00 - $140,000.00 per year

Position Overview

The Manufacturing Engineer II/III plays a critical role in owning, sustaining, and improving manufacturing processes for next-generation polymeric heart valves. This position provides advanced technical leadership on the production floor and serves as a key liaison between Manufacturing, R&D, Quality, and Process Engineering.

At the senior level, this role is expected to independently drive process development, lead cross-functional projects, and champion continuous improvement initiatives in a highly regulated, fast-paced environment.

Key Responsibilities

• Process Ownership & Support

• Lead day-to-day technical support for manufacturing operations, ensuring process stability, repeatability, and product quality.
• Serve as the primary engineering owner for one or more manufacturing processes (e.g., polymer preparation, molding, assembly, or test).
• Process Development & Optimization

• Design, develop, and optimize manufacturing processes to improve yield, efficiency, and scalability.
• Analyze process capability, identify sources of variability, and implement robust solutions.
• Cross-Functional Collaboration

• Partner with R&D to transition new products and processes into manufacturing (NPI).
• Collaborate with Quality and Regulatory teams to ensure compliance with GMP, ISO 13485, and FDA requirements.
• Documentation & Validation

• Author and maintain manufacturing work instructions, test methods, and equipment specifications.
• Lead and execute process validations (IQ/OQ/PQ) and support design transfer activities.
• Testing & Data Analysis

• Plan and conduct testing of raw materials, in-process components, and finished devices.
• Perform statistical analysis to support process improvements and risk mitigation.
• Continuous Improvement

• Lead or participate in Lean/Kaizen initiatives, applying tools such as root cause analysis (RCA), 5 Whys, DOE, SPC, and value stream mapping.
• Drive efforts to reduce waste, improve throughput, and enhance product quality.
• Equipment & Tooling

• Specify, qualify, and support manufacturing equipment and tooling.
• Troubleshoot complex equipment and process issues with a structured, data-driven approach.

Qualifications • Education:

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Chemical, Materials Science, or related field).
• Experience:

• Engineer II: 3–5\+ years of experience in manufacturing or process engineering in a regulated industry.
• Engineer III: 5–8\+ years of experience with demonstrated ownership of processes and successful project leadership.
• Technical Skills:

• Proficiency with SolidWorks or similar 3D CAD software.
• Strong understanding of complex geometries, GD&T, and technical drawings.
• Experience with process validation, statistical analysis, and DOE.
• Working knowledge of Lean manufacturing and continuous improvement methodologies.
• Additional Skills:

• Strong analytical, troubleshooting, and problem-solving capabilities.
• Excellent communication and cross-functional collaboration skills.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint).

Additional Information

• The primary work location for this position is Salt Lake City, UT.
• This is a 100% on-site position.
• Less than 10% travel required.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Why Join Us

Make a direct impact on life-saving cardiovascular technology.

Work at the forefront of innovative polymeric medical device manufacturing.

Grow your career in a collaborative, fast-moving, and mission-driven environment.

Job Type: Full-time

Pay: $90,000.00 - $140,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person