Product Development Engineer II - Quality Tech Services, LLC

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.

Product Development Engineer II Ideal Candidate Profile

QTS is currently seeking an energetic, responsive and well-organized full time Product Development Engineer II that will be responsible for new product design and project planning as well as ongoing support throughout the product’s life cycle. You will work in a dynamic and collaborative environment, ensuring compliance with quality requirements, customer specifications, and industry standards while driving innovation and efficiency in meeting customer needs. Your role will involve technical leadership, problem-solving, and continuous improvement initiatives.

Product Development Engineer II Job Summary

• Analyze and interpret customer requirements and specifications to propose new package designs and end-of-line services (inspection, cleaning, packaging, labeling, sterilization, routine testing).
• Create and update design documentation (i.e., bill of material (BOM), process flow, control plan, inspection plan, shipping configurations, etc.) for both new and existing product lines.
• Assess feasibility of new project opportunities.
• Work with Estimating and cross-functional technical teams to build complete, competitive, and profitable project proposals and production quotes.
• Plan and manage technical aspects of new product initiation (NPI) project plans and timelines in collaboration with Project Managers.
• Write project Master Validation Plan (MVP) summaries for new projects inclusive of sealing, packaging, cleaning, and sterilization, by obtaining customer requirements and collaborating with technical specialists.
• Plan, execute, and own package design validations (package performance testing and stability testing) including formal validation protocols, sample preparation and testing work instructions, product conditioning plans, formal validation reports, change assessments, and adoption assessments.
• Work with suppliers and supplier quality to create QTS receiving inspection plans and component qualification plans for packaging and medical device components.
• Review and assess Process Engineering-, Supply Chain-, and Quality-initiated changes to ensure continued compliance to customer requirements.
• Provide product line and customer guidance to quality, production, supply chain, process engineering, manufacturing engineering, and others.
• Participate in or lead customer calls (discovery calls, routine project updates, etc.)
• Work directly with customer to negotiate, finalize, and document project and product requirements.
• Establish and maintain working relationships with key customer technical experts.

Product Development Engineer Skills and Experience

• Bachelor’s degree in engineering (Biomedical, Mechanical, Packaging, or a related field).
• 5 years of experience as an engineer in medical device industry or similar role. Knowledge of commonly used concepts, practices, and procedures in medical device end-of-line manufacturing.
• Basic proficiency with CAD software (e.g., SolidWorks, AutoCAD) for design purposes and previous technical writing experience.
• Awareness of standard statistical techniques such as capability analysis, ANOVA, design of experiments (DOE), normality testing, etc.
• Ability to read, understand, and interpret regulations and technical standards as they pertain to medical device packaging, cleaning, and sterilization. Knowledge and training pertaining to GMP, traceability and risk analysis.
• Effective verbal and written communication skills.
• Ability to work well in team-oriented environments, including working on and/or leading cross-functional project teams.
• Willingness to learn new processes and adapt to changing project requirements. Ability to prioritize, multitask and work in a fast-paced team environment.
• Proficient in Outlook, Word, Excel, PowerPoint, Teams, etc.

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 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.