Director of Engineering NPI

Overview

About Cretex Medical

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry.  Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly.  Learn more at www.cretexmedical.com.

 

Position summary

The Director of Engineering serves as an organization leader for engineering and technical teams. This position provides direct and indirect management over technical staff. The Director will be responsible for ensuring technical functions meet the needs of our customers including robust program management, successful new project launches, and sustaining engineering support throughout the product lifecycle. As the Engineering leader, the individual will contribute to company strategic planning, and have ownership over engineering objectives and annual performance indicators. The Director of Engineering will drive process improvement within department function and uphold compliance to Quality Management system.

Responsibilities

Essential Job Functions                                                       

• Manage the engineering product life cycle
• Contribute as an engineering thought leader on the leadership team and provide regular updates on new programs, assigned KPIs, and technical initiatives
• Strengthen and expand engineering technical services through process improvement and executing strategic initiatives
• Research industry specific technologies and lead capital investments is supporting technology
• Assist operations with selecting and implementing appropriate technologies that result in lower manufacturing costs, lower process variability and higher manufacturing capability
• Participate in new program feasibilities and provide technical insights on program challenges and opportunities
• Coach and mentor the engineering manager, project leaders, and extended team members on new product development and transfer projects
• Develop skill sets of assigned staff to meet functional area objectives, Cretex business objectives and employees’ professional goals
• Advise personnel in product and process validation and verification activities and train in best practices for medical device manufacturing
• Coordinate with leadership colleagues across various functions to foresee/understand critical project activities and enable them to manage team resources
• Maintain responsibility for development and validation of capable production processes that meet operational objectives
• Drive DFM discussions with NPI and Operations on all new products
• Evaluate and continuously improve all available internal and external technologies including equipment, special processes, and materials
• Provide engineering resources in support of all necessary projects and activities
• Review department expenditures, including compensation, expenses, maintenance, and equipment and software upgrades
• Participate in cost modeling and pricing exercises for new and existing programs to support adding profitable opportunities and maintaining competitiveness
• Help our sales team build relationships with our customers by providing technical solutions and project updates 

Qualifications

Minimum Requirements, Education & Experience (incl. KSA’s and certifications)

• Bachelor’s Degree in Engineering or related field
• 15 years of engineering experience
• 7 years of experience in medical manufacturing
• 7 years of experience managing direct reports
• CAD and related design computer software (SolidWorks, AutoCAD)
• Manufacturing process knowledge
• Knowledge of Quality System: ISO9001, ISO13845
• Med Device regulation, design
• Project management
• Problem solving and analysis
• Clear and effective verbal and written communication skills

Desirable Criteria & Qualifications

• Experience with MRP/ERP systems
• Experience in 510k and FDA submissions
• PMP or similar Project Management certification
• Lean manufacturing or Six Sigma certification(s)
• Executive Management training

What is it like to work at Cretex Medical?  

We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement.  

 

Here are some of things that employees have said about working for Cretex Medical:  

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