BD Nogales Norte · 1 week ago
Engineering Manager, Integrated Systems, Development
Louisville, CO
Full-time
Onsite
Senior Level, Lead/Staff
$115K/yr - $190K/yr
10+ years expBD is one of the largest global medical technology companies in the world, and they are seeking an experienced Engineering Manager to lead their Integrated Systems Development team within R&D. This role is crucial for driving verification testing, launch readiness, and post-launch support for complex medical devices, ensuring product reliability and compliance with global regulatory standards.
Consumer Goods
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
Qualification
Required
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
Benefits
A valuable, competitive package of compensation and benefits programs
Company
BD Nogales Norte
Somos una empresa multinacional dedicada a la manufactura de dispositivos de uso médico a través de los cuales seguimos impulsando el mundo de la salud.
1001-5000 employees
H1B Sponsorship
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2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Late StageCompany data provided by crunchbase