Principal Controls Engineer at Engtal in Indianapolis, IN

Job Overview

As a Principal Controls Engineer, you’ll lead controls and design engineering work for medical device product development, connecting research, engineering, and manufacturing. You’ll guide project management and scheduling, translate product needs into clear design controls, and help teams meet applicable regulatory and legal compliance standards. Your impact: By strengthening engineering validation and medical device testing, you help teams deliver safer, more reliable products for patients and clinicians.

Responsibilities

• Lead mechanical design and product development, including computer-aided design (CAD), three-dimensional (3D) modeling, and geometric dimensioning and tolerancing (GD&T).
• Plan and execute design of experiments, experimental design, data analysis, and statistical analysis for research and product testing.
• Coordinate cross-functional collaboration among engineering, manufacturing, laboratory, and clinical teams.
• Support testing and validation in biotechnology and biomedical engineering for medical devices, including work involving assays, cell culture, biochemistry, and molecular biology.
• Apply design controls and relevant Food and Drug Administration (FDA) regulations, International Organization for Standardization (ISO) 13485, and good manufacturing, laboratory, and clinical practice (GMP, GLP, and GCP) requirements.

Skills

• Strong project management, project scheduling, technical proficiency, and communication skills; able to use Python for analysis.
• Experience with mechanical engineering, medical device design, engineering product development, and manufacturing.
• Proficiency with SolidWorks or comparable CAD software; knowledge of mechanical design and 3D modeling for product design.
• Understanding of biomedical regulatory compliance, engineering validation, medical device testing, and clinical trials.
• Research or laboratory experience is preferred, including statistical analysis for research; familiarity with math, biochemistry, biotechnology, assays, cell culture, and molecular biology is an asset.

Pay: $140,000.00 - $180,000.00 per year

Work Location: In person