Engineering Manager, Integrated Systems, Development

Engineering Manager, Integrated Systems, Development

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Job Description Summary

BD’s Urology and Critical Care (UCC) business is seeking a dynamic and experienced Engineering Manager to lead our Integrated Systems Development team within R&D. This role is pivotal in driving verification testing, launch readiness, and post‑launch support for complex electro‑mechanical medical devices. The successful candidate will ensure product reliability, performance, and compliance with global regulatory standards.

Company Overview

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Summary

BD’s Urology and Critical Care (UCC) business is seeking a dynamic and experienced engineering leader to lead our Integrated Systems Development team within R&D. This role is pivotal in driving verification testing, launch readiness, and post‑launch support for complex electro‑mechanical medical devices. The successful candidate will ensure product reliability, performance, and compliance with global regulatory standards.

Key Responsibilities

• Lead and Inspire:
  Serve as a player‑coach, managing and mentoring a growing team of engineers responsible for the downstream lifecycle of medical device systems, from design freeze through commercialization and post‑launch sustenance.
• Cross‑Functional
  
  Collaboration:
  
  Partner with R&D, Product Management, Quality Assurance, Regulatory Affairs, and Manufacturing to deliver seamless product launches and lifecycle support.
• Ensure Compliance and Quality:
  Establish and maintain robust engineering processes, best practices, and documentation aligned with medical device regulations (e.g., ISO 13485, FDA QSR).
• Technical Leadership:
  Conduct design reviews, risk assessments, and verification/validation activities to guarantee system integrity and performance.
• Team Development:
  Foster a culture of innovation, continuous improvement, and technical excellence through coaching and mentorship.
• Project Ownership:
  Oversee schedules, budgets, and resources to ensure timely delivery of high‑quality products.
• Lifecycle Management:
  Define and implement sustenance strategies for multiple platform products in collaboration with Reliability, Service & Repair, and Quality Assurance teams.
• Innovation:
  Identify and integrate new technologies and methodologies to enhance testing efficiency and automation across multiple sites.
• Subject Matter Expertise:
  Act as a technical authority for multiple UCC products.

Required Skills / Experience

• Bachelor’s or Master’s degree in Electrical, Mechanical, Biomedical Engineering, or a related technical discipline.
• 10+ years of engineering development experience, including 5+ years in leadership or management, preferably in the medical device industry.
• Proven expertise in designing and integrating complex embedded systems (hardware, software, firmware).
• In‑depth knowledge of medical device regulatory requirements (FDA 21 CFR Part 820, ISO 13485) and design controls.
• Experience with risk management tools (e.g., FMEA) and verification/validation processes.
• Exceptional leadership, communication, and interpersonal skills with the ability to inspire and motivate technical teams.
• Strong analytical and problem‑solving skills with a structured approach to complex challenges.
• Ability to manage multiple projects and adapt to shifting priorities in a fast‑paced environment.

Salary Range Information

$ - $ USD Annual

Location:

USA CO – Louisville

We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally‑protected characteristics.