Manufacturing Engineer II or III - NPI

Cretex • Bloomington, MN

51d • $75,000 - $136,200

About The Position

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. Manufacturing Engineer II or III - NPI Ideal Candidate Profile QTS is currently seeking an energetic, responsive, and well-organized full-time Manufacturing Engineer. This position is within our New Product Introduction (NPI) team and will be responsible for developing and executing project plans to source, clean, assemble, package, label, and sterilize new medical devices. Manufacturing Engineer II or III - NPI Job Summary 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. Initiates and completes technical activities leading to new or improved products or design for manufacturability or processes for current and next generation programs and to meet strategic goals and objectives of the company. Analyze and solve problems from basic engineering principles, theories, and concepts. Identify the root cause of manufacturing process and product nonconformities. Identify and implement the necessary actions to correct and prevent recurrence though 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.

Requirements

• 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 (i.e., ProE, Unigraphics, SolidWorks, etc.).
• Excellent communication and influencing skills.
• High level of energy, personal accountability, and integrity.
• Detail oriented; checks own work, keeps accurate records, organizes information effectively.
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher).
• Clear and effective verbal and written communication skills.
• Ability to work in a fast-paced team environment.
• Ability to prioritize and communicate with stakeholders.

Nice To Haves

• Continuing Education; including participation in local chapters, associations, and/or organizations.
• Experience in an ISO13485/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.

Responsibilities

• 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.
• Initiates and completes technical activities leading to new or improved products or design for manufacturability or processes for current and next generation programs and to meet strategic goals and objectives of the company.
• Analyze and solve problems from basic engineering principles, theories, and concepts.
• Identify the root cause of manufacturing process and product nonconformities. Identify and implement the necessary actions to correct and prevent recurrence though 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.

Benefits

• Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees.
• Cretex's medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week.
• Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Number of Employees: 1,001-5,000 employees