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Cretex Medical Component and Device Technologies Director of Engineering NPI in Brooklyn Park, Minnesota

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
  • Understand customer needs and the core business markets we serve

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 ystems
  • Experience in 510k and FDA submissions
  • PMP or similar Project Management certification
  • Lean manufacturing or Six Sigma certification(s)
  • Executive Management training

Physical & Environmental Demands Cretex Companies use cutting oils, solvents, and other chemicals in the manufacturing process. Testing is conducted on a periodic basis to ensure that all chemicals are kept well below the OSHA permissible exposure levels. Qualifications 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: "The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right." "I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it." "I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives." We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member. Company Benefits Cretex Medical offers a full benefit package to its employees. Benefits include medical, dental, vision and life insurance options. Cretex Medical also offers a 401(k)-retirement plan with employer match, profit sharing, short- and long-term disability insurance, paid time off and holiday pay. Cretex Medical also offers company-specific benefits, such as:

  • Employee Appreciation events
  • Volunteer Opportunities
  • Training and Development opportunities
  • Tuition Reimbursement
  • New state-of-the-art facility in Brooklyn Park!

Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law. Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.