Hobbsnews
Engineering Manager, Integrated Systems, Development
Hobbsnews, Louisville, Colorado, United States, 80028
Job Description Summary
BD’s Urology & Critical Care business seeks an Engineering Manager to lead the Integrated Systems Development team within R&D. The role focuses on verification testing, launch readiness, post‑launch support for complex electro‑mechanical medical devices. Successful candidates ensure product reliability, performance, and global regulatory compliance.
Key Responsibilities
Lead and Inspire : Player‑coach managing a team of engineers responsible for downstream lifecycle of medical device systems, from design freeze through commercialization and post‑launch sustenance.
Cross‑Functional Collaboration : Partner with R&D, Product Management, QA, Regulatory Affairs, & Manufacturing to deliver seamless product launches & lifecycle support.
Ensure Compliance & Quality : Establish robust engineering processes, best practices, & documentation aligned with medical device regulations (e.g., ISO 13485, FDA QSR).
Technical Leadership : Conduct design reviews, risk assessments, & verification/validation activities to guarantee system integrity & performance.
Team Development : Foster culture of innovation, continuous improvement, technical excellence through coaching & mentorship.
Project Ownership : Oversee schedules, budgets, & resources to ensure timely delivery of high‑quality products.
Lifecycle Management : Define & implement sustenance strategies for multiple platform products with Reliability, Service & Repair, & QA teams.
Innovation : Identify & integrate new technologies & methodologies to enhance testing efficiency & automation across sites.
Subject Matter Expertise : Act as technical authority for multiple UCC products.
Required Skills / Experience
Bachelor’s or Master’s degree in Electrical, Mechanical, Biomedical Engineering, or related discipline.
10+ years of engineering development experience, including 5+ years in leadership/management, preferably in medical device industry.
Proven expertise in designing & integrating complex embedded systems (hardware, software, firmware).
In‑depth knowledge of medical device regulatory requirements (FDA 21 CFR Part 820, ISO 13485) & design controls.
Experience with risk management tools (e.g., FMEA) & verification/validation processes.
Exceptional leadership, communication, & interpersonal skills; ability to inspire & motivate technical teams.
Strong analytical & problem‑solving skills with structured approach to complex challenges.
Ability to manage multiple projects & adapt to shifting priorities in fast‑paced environment.
Why Join Us? A career at BD values your opinions & contributions, encourages authentic self, and promotes learning & daily improvement. We seek people who see the big picture & drive to reinvent future of health.
Primary Work Location USA CO - Louisville
Salary Range Information $115,200.00 - $189,700.00 USD Annual
Becton, Dickinson, and Company is an Equal Opportunity Employer. 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.
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Key Responsibilities
Lead and Inspire : Player‑coach managing a team of engineers responsible for downstream lifecycle of medical device systems, from design freeze through commercialization and post‑launch sustenance.
Cross‑Functional Collaboration : Partner with R&D, Product Management, QA, Regulatory Affairs, & Manufacturing to deliver seamless product launches & lifecycle support.
Ensure Compliance & Quality : Establish robust engineering processes, best practices, & documentation aligned with medical device regulations (e.g., ISO 13485, FDA QSR).
Technical Leadership : Conduct design reviews, risk assessments, & verification/validation activities to guarantee system integrity & performance.
Team Development : Foster culture of innovation, continuous improvement, technical excellence through coaching & mentorship.
Project Ownership : Oversee schedules, budgets, & resources to ensure timely delivery of high‑quality products.
Lifecycle Management : Define & implement sustenance strategies for multiple platform products with Reliability, Service & Repair, & QA teams.
Innovation : Identify & integrate new technologies & methodologies to enhance testing efficiency & automation across sites.
Subject Matter Expertise : Act as technical authority for multiple UCC products.
Required Skills / Experience
Bachelor’s or Master’s degree in Electrical, Mechanical, Biomedical Engineering, or related discipline.
10+ years of engineering development experience, including 5+ years in leadership/management, preferably in medical device industry.
Proven expertise in designing & integrating complex embedded systems (hardware, software, firmware).
In‑depth knowledge of medical device regulatory requirements (FDA 21 CFR Part 820, ISO 13485) & design controls.
Experience with risk management tools (e.g., FMEA) & verification/validation processes.
Exceptional leadership, communication, & interpersonal skills; ability to inspire & motivate technical teams.
Strong analytical & problem‑solving skills with structured approach to complex challenges.
Ability to manage multiple projects & adapt to shifting priorities in fast‑paced environment.
Why Join Us? A career at BD values your opinions & contributions, encourages authentic self, and promotes learning & daily improvement. We seek people who see the big picture & drive to reinvent future of health.
Primary Work Location USA CO - Louisville
Salary Range Information $115,200.00 - $189,700.00 USD Annual
Becton, Dickinson, and Company is an Equal Opportunity Employer. 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.
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