Manufacturing Engineer II or III - NPI

Manufacturing Engineer II or III – NPI

Join QTS Medical Device Outsourcing and help support 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.

• Develop, maintain, and improve procedures, documentation, tools, fixtures, and programs for end‑of‑line manufacturing of new and existing medical devices, based on external customer specifications.
• Work closely with Project Managers to assist with planning, cost estimation, and timeline development for defined projects.
• Interface with Quality to integrate new products or processes into the existing production area.
• Initiate and complete technical activities leading to new or improved products or design for manufacturability or processes for current and next‑generation programs to meet strategic goals.
• Analyze and solve problems from basic engineering principles, theories, and concepts.
• Identify the root cause of manufacturing process and product nonconformities and implement necessary actions through the corrective and preventative action process.
• Perform and document process risk analysis (pFMEA) and implement risk mitigations.
• Develop and implement manufacturing process, business process, and product improvements with minimal supervisory guidance.
• Maintain and approve device routers and bill of materials.
• Develop manufacturing processes utilizing statistical process control as appropriate.
• Maintain and approve manufacturing procedures.
• Design and coordinate fabrication and implementation of process fixturing or gauging.
• Specify and lead qualification activities for new packaging and device components.

• Bachelor’s Degree in Mechanical, Industrial, or other Engineering Science.
• 3 – 7 years of experience in the medical device industry.
• Knowledge of Medical Device part / production process approval processes (PPAP) for medical devices.
• Experience with cleaning, sterilization, packaging, and/or sealing process validations for terminally sterilized medical devices.
• Experience working directly with suppliers in a regulated industry.
• Understanding of 3D CAD software (e.g., ProE, Unigraphics, Solid Works).
• Excellent communication and influencing skills.
• High level of energy, personal accountability, and integrity.
• Detail oriented; checks own work, keeps accurate records, organizes information effectively.
• Clear and effective verbal and written communication skills.
• Ability to work in a fast‑paced team environment.
• Ability to prioritize and communicate with stakeholders.

• Continuing Education; participation in local chapters, associations, and/or organizations.
• Experience in an ISO
  13485/GMP environment.
• Engineering experience in a manufacturing facility.
• Manufacturing process design and validation.
• Manufacturing equipment and fixture/gauge design.
• Lean manufacturing, including statistical analysis.
• Manufacturing automation, including electronic visual inspection.

• “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!”

USD $75,000.00 – USD $ /Yr. This range reflects the base hourly rate or annual salary for positions within this job grade, based on our market‑based pay structures. Actual compensation will depend on skills, relevant experience, education, internal equity, business needs, and local market conditions. Offers are rarely made at the minimum or maximum of the range.

• 401(k) retirement savings plan with a company match contribution.
• Onsite health clinics.
• Discretionary holiday bonus program (based on years of service).
• Cretex University training program.
• 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost.
• Wellness program with incentives.
• Employee death…