Software Engineer

Katalyst CRO
Dearborn, Michigan, United StatesFull-timePosted Sep 16, 2026

About the role

Key Responsibilities

Lead end-to-end systems engineering activities across the product development lifecycle following the V-Model methodology.

Gather, analyze, and manage customer and stakeholder requirements using Polarion and ensure complete traceability.

Drive Automotive SPICE (ASPICE) process implementation and compliance across system development activities.

Develop and maintain system architectures, product definitions, and technical solutions for automotive programs.

Lead Digital Transformation initiatives utilizing Dassault Systèmes 3DEXPERIENCE (3DX) and PLM platforms.

Design and implement digital prototypes, process automation solutions, and engineering workflow improvements.

Apply Value Stream Mapping (VSM) techniques to identify process inefficiencies and drive continuous improvement initiatives.

Ensure compliance with Functional Safety (ISO 26262) and Automotive Cybersecurity (ISO/SAE 21434) standards.

Collaborate with cross-functional teams including engineering, product management, manufacturing, and executive leadership.

Develop executive-level presentations, strategic storyboards, and reports to support business and program decisions.

Present complex technical concepts and program recommendations to senior leadership and stakeholders.

Define and execute system-level and integration-level test strategies using CANoe, CAN, and LIN tools.

Support verification and validation activities to ensure product quality, performance, and regulatory compliance.

Lead technical workshops, design reviews, and stakeholder meetings to align business and engineering objectives.

Utilize Python, MATLAB, VBA, and other engineering tools to improve efficiency, reporting, and analysis capabilities.

Support project planning, risk management, resource coordination, and program governance activities.

Conduct benchmarking, Value Analysis/Value Engineering (VAVE), and product optimization studies for automotive systems.

Act as a trusted technical consultant and advisor, aligning engineering solutions with organizational and customer objectives.

Qualification

Required:

Bachelor's degree in mechanical engineering, Electrical Engineering, Systems Engineering, Automotive Engineering, or a related engineering discipline.

Preferred

Master's degree in electrical engineering, Systems Engineering, Automotive Engineering, or related field.

Responsibilities

  • Lead end-to-end systems engineering activities across the product development lifecycle following the V-Model methodology.
  • Gather, analyze, and manage customer and stakeholder requirements using Polarion and ensure complete traceability.
  • Drive Automotive SPICE (ASPICE) process implementation and compliance across system development activities.
  • Develop and maintain system architectures, product definitions, and technical solutions for automotive programs.
  • Lead Digital Transformation initiatives utilizing Dassault Systèmes 3DEXPERIENCE (3DX) and PLM platforms.
  • Design and implement digital prototypes, process automation solutions, and engineering workflow improvements.
  • Apply Value Stream Mapping (VSM) techniques to identify process inefficiencies and drive continuous improvement initiatives.
  • Ensure compliance with Functional Safety (ISO 26262) and Automotive Cybersecurity (ISO/SAE 21434) standards.

Qualifications

  • Bachelor's degree in mechanical engineering, Electrical Engineering, Systems Engineering, Automotive Engineering, or a related engineering discipline.
  • Master's degree in electrical engineering, Systems Engineering, Automotive Engineering, or related field.

Skills mentioned

Systems EngineeringSystem DesignPythonMATLABAutomationWorkflow AutomationSoftware TestingIntegration TestingCybersecurityEmbedded Systems

About Katalyst CRO

Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. With a strong foundation in cGxP & ICH-GCP-compliant clinical research, we offer fully customizable, end-to-end solutions, covering everything from pre-clinical studies to Phase I–IV clinical trials, regulatory affairs, and validation services—ensuring seamless drug and device development. Our Expertise Across the Product Lifecycle: 🔹 Pre-Clinical Research & Development – In-Vitro (Lab-Based) & In-Vivo (Animal) Studies 🔹 Clinical Research & Development – Trial Management, Data Management, Biostatistics, Medical Writing, Pharmacovigilance 🔹 Regulatory & Quality Compliance – cGxP (GMP, GLP, GCP) Validations, Regulatory Affairs, Process & System Validations 🔹 Strategic Human Resourcing – Connecting top-tier talent to life sciences and healthcare organizations With deep industry expertise and a flexible, client-centric approach, Katalyst CRO leverages an advise-build-operate model to de-risk and accelerate research programs. We help organizations achieve regulatory success, optimize quality systems, and bring life-changing therapies to market faster—ultimately improving global patient health and safety. 💡 Partner with Katalyst CRO to bring breakthrough therapies to market with confidence. 📩 Let’s connect and shape the future of healthcare together!

Business Consulting and Services51-200 employeesSouth Plainfield, NJ

H-1B sponsorship history

Historical employer filing data was found for Katalyst CRO. The employer record includes 71 historical certified applications. This is employer-level history, not a guarantee that this role currently offers sponsorship.