The Director, Engineering candidate will be a crucial CONMED leader for manufacturing engineering. This role will have high impact and high visibility! You’ll be supported by a leadership team that promotes engagement through professional development, new challenges and growth opportunities over the course of your career. Come inspire us through your dedication, creativity, and exceptional performance - we’ll do the same for you! If you are an engineering leader looking to make a difference at a growing medical technology company, apply now and join a team that is driving exceptional results!

MINIMUM QUALIFICATIONS

• Bachelor’s Degree Engineering
• 10 years experience in regulatory setting
• Up to 20% travel

PREFERRED QUALIFICATIONS

• 10 years manufacturing medical device
• Green Belt, Black Belt and Lean knowledge preferable
• Proven ability to build, lead and develop a highly motivated and world-class team to achieve the goals of the company’s manufacturing initiatives
• Strong leadership and interpersonal skills
• Ability to effectively network and interface with all levels of the organization
• Experience with cGMP, manufacturing, and equipment support
• Working knowledge of safety regulations, federal regulations, and other regulations, e.g. QSR’s, ISO, ISO 13485, etc. in a manufacturing environment
• Experience with automated and semi-automated equipment and processes
• Demonstrated ability to communicate upward, outward and to large groups of direct labor
• Proven ability to follow detailed directions in a manufacturing and engineering cGMP environment
• Solid understanding of manufacturing systems, processes, and equipment (documentation, compliance, safety, change control, etc.)
  Please note: This position is not eligible for employer based sponsorship.

• Develop a continuous improvement pipeline of initiatives to align with the business needs to drive efficiencies and cost improvements to the products on scope
• Manage and provide leadership for all sustaining manufacturing engineers, working first and second shifts in 24/7 operation
• Management of projects, timelines, and requirements to support manufacturing engineering and manufacturing
• Supports process transfers from engineering to manufacturing including processes and equipment training
• Provides and manages technical engineering and mechanical support for maintaining, repairing, troubleshooting, and modifying equipment
• Manages, creates and/or modifies equipment maintenance procedures, SOP’s, and requirements
• Support writing and reviewing operating procedures, documents, and reports
• Performs investigations for non-conformance product equipment events and ensures thorough and effective resolution
• Collaborates on equipment performance testing to support new product testing and equipment qualifications
• Provides QS validation input and support for new equipment validations
• Champion a culture of organizational safety with respect to behaviors, processes, and environment
• Reviews and approves calibration datasheets, work orders, and change controls
• Ensures and models compliance with established business policies and ensures all applicable safety, quality and regulatory regulations are followed by manufacturing personnel
• Ensures completion of all employee training required engineering and maintenance methods including cGMP guidelines, and SOP’s
• Drafts, reviews, revises, and executes SOPs, technical reports, nonconformance’s, investigations etc
• Analyzes data, results, and provides conclusions and performance metrics