BD (Tissuemed Ltd) · 5 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 within R&D, focusing on verification testing, launch readiness, and post-launch support for complex medical devices.
Health CareHospitalMedicalMedical Device
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 (Tissuemed Ltd)
Experts in bioadhesives: Tissuemed develops and markets adhesive films to prevent air, blood and fluid leaks encountered in surgery.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$0.05M2021-12-09Acquired
2015-06-01Grant· $0.05M
Recent News
2025-02-21
Company data provided by crunchbase