Director of Engineering
Quality Tech Services, LLC

Overview

About QTS

QTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging and sterilization management. QTS is part of the Cretex Medical family of companies. Learn more at www.qtspackaging.com and www.cretexmedical.com.

Director of Engineering Ideal Candidate Profile

QTS is currently seeking an energetic, responsive, and well-organized full-time Director of Engineering responsible for providing direct and indirect management for engineering and technical teams. 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 the 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 with the Quality Management system.
Responsibilities

Director of Engineering Job Summary

• 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 in 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 the 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
• Participate in trade shows, customer visits, customer audits, and regulatory audits

Qualifications

Director of Engineering Skills and Experience

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 Systems: 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 for QTS?

At QTS, we are passionate about quality as the services we provide have a direct impact on the quality of life for others and we pride ourselves on our culture and work environment. Here are some of the things that employees have said about working at QTS:

"I would describe my coworkers as kind and friendly."

"... I interned at QTS, then I went back to school... I was brought on as a shared service engineer, then I moved into a role with more customer interaction associated with it. All in all, a good fun ride so far and I can't wait to keep it going!"

"Three words that I would use to describe QTS's culture are Respectful, Fast-paced, and Fun!"

We encourage you to explore the many opportunities that Quality Tech Services could offer you as an employee and as a valued team member.

QTS Benefits:

As a Cretex Medical company, QTS offers a full benefit package to its employees. Benefits include medical, dental, vision, and life insurance options. QTS also offers a 401(k) retirement plan with employer match, profit sharing, short- and long-term disability insurance, paid time off, and holiday pay.

QTS also offers company-specific benefits, such as:

• Free Parking
• Employee Appreciation Events
• Volunteer Opportunities
• Training and Development opportunities
• Tuition Reimbursement
• Annual Flu Vaccination Clinics

Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, 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.

---