Job Summary

We are seeking a skilled Manufacturing Engineer to lead and optimize our production processes for our medical device company. This role is responsible for driving manufacturing efficiency, product quality, cost reduction, and continuous improvement while ensuring full compliance with ISO 13485 and regulatory requirements. As part of a small team, the role demands flexibility and the ability to handle multiple responsibilities with low oversight.

Key Responsibilities

• Design, develop and improve manufacturing processes for new and existing products to maximize efficiency and yield while reducing scrap and downtime.
• Provide ongoing engineering support on the production floor to resolve technical issues, perform root cause analysis and implement corrective actions for manufacturing and field-related issues.
• Manage document change orders, update engineering drawings, work instructions, SOPs, and manufacturing documentation to maintain ISO 13485 compliance.
• Create and modify 3D models and 2D drawings using SolidWorks to support design improvements and manufacturability.
• Oversee equipment maintenance, calibration, and validation (IQ/OQ/PQ); conduct process capability studies and statistical process control.
• Track and analyze scrap data to identify trends and drive design/process improvements that reduce waste and cost.
• Proactively identify opportunities and drive projects with minimal supervision in a fast-paced, small-team environment.
• Collaborate cross-functionally with R&D, Quality, Marketing and Regulatory teams

Qualifications

• Education: Bachelor’s degree in Manufacturing, Mechanical, Biomedical Engineering, or a related field.
• 5-8+ years of experience in a manufacturing engineering role, preferably in the medical device or regulated manufacturing industry.
• Strong working knowledge of ISO 13485, Lean/Six Sigma, Statistical Process Controls and Process Validation
• Experience with document change control processes and Quality Management Systems (QMS)
• Proficient with 2D and 3D CAD modeling (Ie, SolidWorks)
• Ability to work independently with a high degree of initiative and flexibility.
• Excellent problem-solving, project management, communication and leadership skills

Preferred Skills:

• Knowledge of injection molding processes and design for manufacturability (DFM) is a strong bonus.
• Six Sigma Green/Black Belt certified
• Experience leading technical projects and mentoring team members

Pay: $100,000.00 - $130,000.00 per year

Benefits:

• Paid time off

Location:

• Orem, UT 84057 (Preferred)

Ability to Commute:

• Orem, UT 84057 (Required)

Ability to Relocate:

• Orem, UT 84057: Relocate before starting work (Preferred)

Work Location: In person