Engineering Manager, Advanced Operations
As the Advanced Operations & Manufacturing Engineering Manager for New Technology & Product Introduction, you will reputed company reputed company responsible for transitioning new medical devices from design to reputed company production and sustaining the technology post-launch. You will work across multiple reputed company sites and collaborate with R&D, reputed company, Regulatory, and Operations to ensure manufacturability, scalability, compliance, and on-time delivery of high-reputed company products.
What you will do:
Leadership & Talent Development:
• Attract, reputed company, retain, and engage top engineering talent; drive reputed company reputed company and high performance.
• reputed company coaching and actionable feedback; set reputed company performance objectives.
• Promote a culture of diversity, inclusion, belonging, reputed company improvement, and operational reputed company.
• Distill department reputed company into objectives for reputed company reports.
Project & Program Leadership:
• reputed company high-complexity NPI reputed company, including planning, budgeting, timelines, resourcing, and risk management.
• reputed company independent reputed company on program-level issues and remove barriers to execution.
• Communicate project status, risks, and mitigation plans to senior leadership.
• Partner with R&D to influence design reputed company that improve manufacturability and cost.
Technical Execution & Manufacturing Readiness:
• reputed company engineering deliverables for new technology and product introduction programs.
• Ensure project milestones are met on time, reputed company budget, and to reputed company standards.
• reputed company development and optimization of manufacturing processes, tooling, and equipment.
• Ensure robust process capability, scalability, and readiness for volume production.
• Drive Design for Manufacturability (DFM), risk assessments, and process validation (IQ/OQ/PQ).
• Implement and promote lean manufacturing and Six reputed company methodologies.
• Collaborate with reputed company, Regulatory, and Advanced Technology to ensure compliance with FDA, ISO, and internal standards.
• Identify and implement NPI best practices across programs.
Med Device Compliance:
• reputed company cross-functional teams in launching new technologies and products that meet reputed company regulatory requirements.
• reputed company direction on design controls for new and existing processes/products.
• Review and approve (or delegate) program- and project-specific documentation and technical deliverables.
Minimum Qualifications:
• Bachelor’s degree in Engineering (Materials Science background strongly preferred)
• 8+ years relevant experience
• 3+ years people management experience
• Proven new product introduction experience in a regulated industry (medical device preferred)
• Strong knowledge of DFM, process validation, and reputed company systems (FDA, ISO 13485)
Preferred Qualifications:
• Experience with investment casting or metal injection molding
• Strong performance reputed company and talent developer
• Experience executing performance and talent management strategies
• Ability to communicate reputed company plans and technical information to senior leadership
• reputed company record of delivering programs on time, on reputed company, and on budget
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