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Engineering Manager - Princeton, United States - Bongene Search
2 weeks ago
Description
Our long term biotech client in Princeton, NJ is seeking an experienced Engineering Manager to lead the Instrument Operations technical group.
Responsibilities:
Manage and resolve technical issues related to manufacturing processes, equipment, materials, and suppliers to ensure production line uptime.
Coordinate with Third-Party Manufacturers in Asia, involving regular evening conference calls.
Analyze manufacturing data to make informed decisions for process improvement, product performance enhancement, and quality assurance.
Provide technical input to Supply Chain for supplier selection and end-of-life BOM components qualification.
Lead the organization through technical challenges, process/equipment improvements, and continuous improvement initiatives.
Ensure timely execution of on-market product support tasks and adherence to project schedules.
Coordinate cross-functional activities and manage change planning integration with Manufacturing Software Engineering.
Review and approve technical documents such as standard operating procedures, technical specifications, and protocols/reports.
Recruit, manage, coach, and develop engineering talent, and monitor and adjust the annual engineering department budget.
Drive continuous improvement efforts, ensure compliance with regulations, and uphold safety standards.
Interface with external agencies during audits and negotiate quality issue resolutions.
Required Qualifications:
Bachelor's degree in Mechanical, Electrical, Biomedical, Biochemistry, or other applicable STEM fields.
9+ years of relevant work experience, with at least 5 years managing technical teams.
5+ years' experience in the medical device industry or similar regulated industries.
2+ years' experience in design control and product documentation systems.
1+ year working with Project Management concepts and tools.
Strong analytical and technical skills, with the ability to lead process improvement initiatives and address technical challenges.
Effective communication skills and experience collaborating with cross-functional teams.
Ability to mentor others on technical tools such as root cause analysis, LEAN, and six sigma.
Experience in FDA-regulated product manufacturing.
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