Engineering Manager

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Full-Time Eden Prairie, MN, US

4 days ago Requisition

Salary Range: $ To $ Annually

Location: On site: 6455 City West Pkwy Suite 100, Eden Prairie, MN 55344

Office hours: 8am-5pm

• Oversees the overall performance of the engineering responsibilities and employees within; including project completion, quality/regulatory compliance, driving lean initiatives and achieving set metrics.
• Participates in lean daily management and supports relevant metrics and drivers for assigned areas
• Drives plant performance and predictability by establishing, maintaining, and cultivating relevant KPIs, goals, and expectations
• Oversees engineering activities required for the development, verification, and validation (process & development) of market-released product
• Coordinates with site leadership on new product development to ensure operational readiness for the implementation of new processes into production
• Coordinates with planning, production, quality and other support functions to ensure production goals can be met on-time
• Mentors and gives timely performance management feedback to direct staff and provides strong oversight for employees reporting under direct staff; provides clear, consistent, and measurable direction regarding timelines and deliverables
• Understands and makes recommendations for materials, processes, procedures, and equipment within assigned areas to drive cost efficiency and improvement
• Develops engineering process controls to achieve consistent and predictable outcomes
• Ensures a continuous improvement safety culture that drives the assigned areas to achieve the goal of zero incidents
• Supports problem-solving activities and effective corrective actions in assigned areas

• 4+ years of medical device industry/med tech engineering experience required.
• Design control/process validation experience required.
• Thorough understanding of Design for Six Sigma, Risk Management techniques, Statistical Analysis methods, and Design of Experiments required
• Experience with transcatheter heart valve manufacturing and/or biomaterials preferred.

• 5 + years of experience in a regulated engineering production environment
• 3 + years of leadership experience in a regulated engineering production environment

10%

• Microsoft Office Suite, advanced
• Excellent verbal and written communication
• Business Intelligence software
• Project Management
• Current Good Manufacturing Practices (CGMP)
• Lean Manufacturing Practices
• Computer Aided Drafting software
• Technical writing
  
  Statistical methods and analysis

• Ability to lift and/or carry 50 lbs.

Office environment with assigned workstation