Ambu A/S · 2 weeks ago
Senior Manager, Advanced Manufacturing Engineering
Noblesville, IN
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
10+ years expAmbu A/S is a company focused on advanced manufacturing solutions for medical devices. The Senior Manager, Advanced Manufacturing Engineering will lead a multidisciplinary team to develop and implement manufacturing technologies while ensuring compliance with FDA regulations and ISO standards.
Health CareHealth DiagnosticsMedical Device
Responsibilities
Lead a multidisciplinary team of engineers focused on automation and process development
Define and execute a strategic roadmap for advanced manufacturing technologies to support product pipeline growth and regulatory compliance
Serve as the manufacturing engineering lead for major projects, ensuring process transfer readiness
Lead the design and implementation of automated manufacturing and assembly systems (e.g., robotics, PLCs, vision systems, motion control) to support precision, repeatability, and compliance
Deploy smart factory solutions, including MES, SCADA, and IIoT platforms, to enable real-time monitoring, traceability, and predictive analytics
Partner with Quality to ensure automated systems are validated (IQ/OQ/PQ) and fully compliant with 21 CFR Part 820 and other applicable standards
Champion Lean, Six Sigma, and Design for Manufacturability (DFM/DFA) principles across internal and outsourced operations
Implement and monitor KPIs related to OEE, yield, cycle time, and process capability (Cp/Cpk)
Ensure all manufacturing processes comply with FDA QSR, ISO 13485, and relevant product-specific regulations (e.g., IEC 60601, ISO 14971)
Lead automation and equipment capital projects from concept to installation and validation
Manage vendors, timelines, and budgets to ensure efficient project delivery and regulatory alignment
Develop processes to promote cross functional teamwork and the best use of existing competencies
Responsible for developing talent in direct reports
Responsible for managing and resolving conflicts involving direct reports
Responsible for achieving the goals of Ambu as a whole
Facilitates regular communication and meetings with direct reports
Responsible for ensuring information is communicated to direct reports and the rest of the organization when necessary
Responsible for creating the yearly departmental budget and reviewing with the next level up of leadership
All other duties as assigned
Qualification
Required
Bachelor's degree in related field and 10 years of relevant work experience
Five years' experience in management
Five years' experience working in the medical device field
Must be able to speak, read, write and understand English
Experience in automation and data-centric manufacturing environments
Strong background in medical device process validation, and regulatory compliance
Ability to complete complex reports and correspondence
Preferred
Bilingual in Spanish
Company
Ambu A/S
Innovations that make a difference Ever since 1937, Ambu has been rethinking medical solutions to save lives and improve patient care.
5001-10000 employees
H1B Sponsorship
Ambu A/S 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
Represents job field similar to this job
Trends of Total Sponsorships
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknown2002-06-28IPO
Leadership Team
Britt Meelby Jensen
Chief Executive Officer
E
Elsebeth Aagaard
Vice President, Regulatory and Clinical Affairs, Biosafety and Sustainability. Global R&D
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