BD · 4 days 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. They are seeking an experienced Engineering Manager to lead the Integrated Systems Development team, focusing on verification testing, launch readiness, and post-launch support for complex electro-mechanical medical devices.
Health CareMedical DeviceTechnical Support
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
Competitive package of compensation and benefits programs
Rewards and recognition opportunities that promote a performance-based culture
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Maureen Mazurek
Chief Sustainability and EHS Officer
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