Cretex Medical Component and Device Technologies - Dassel, MN

posted 2 months ago

Full-time - Mid Level
Dassel, MN

About the position

The Manufacturing Engineer III at Cretex Medical plays a pivotal role in leading the manufacturing processes and implementing improvements that align with the company's strategic goals. This position is responsible for planning, designing, developing, and maintaining various manufacturing programs and processes, including machining, packaging, welding, assembly, and molding. The engineer will initiate and complete technical activities aimed at enhancing current processes or designing new ones for manufacturability, ensuring that both current and next-generation programs meet the company's objectives. In this role, the Manufacturing Engineer III will analyze and solve problems using fundamental engineering principles, theories, and concepts, tackling a wide range of complex issues that may require innovative approaches or breakthrough technologies. The engineer will interface with quality and manufacturing teams to seamlessly integrate new products or processes into existing production areas. Additionally, they will maintain and approve device routers and bills of materials, monitor equipment performance, and address any issues that lead to non-conforming products or quality concerns. The engineer will also be responsible for maintaining and approving manufacturing procedures, designing and coordinating the fabrication and implementation of process fixturing or gauging, and resolving non-conformances as part of the Material Review Board. They will analyze and map processes to assess efficiency and implement complex project activities, assist with part cost estimation, and mentor junior engineers. Compliance with the company’s Quality System, ISO standards, and medical device requirements is essential in this role.

Responsibilities

  • Initiate and complete technical activities leading to new or improved processes or design for manufacturability for current and next generation programs.
  • Analyze and solve problems from basic engineering principles, theories, and concepts through to a wide range of complex and advanced problems.
  • Interface with quality and manufacturing to integrate new products or processes into the existing production area.
  • Maintain and approve device routers and bill of materials.
  • Monitor performance of equipment, machines, and tools and correct equipment problems or process parameters that produce non-conforming products, low yields, or product quality issues.
  • Maintain and approve manufacturing procedures.
  • Design and coordinate fabrication and implementation of process fixturing or gauging.
  • Resolve non-conformances and participate on Material Review Board.
  • Analyze and map processes, assess efficiency, and implement complex project activities.
  • Assist with part cost estimation.
  • Mentor Engineer I and II.
  • Support and comply with the company Quality System, ISO, and medical device requirements.

Requirements

  • Bachelor's Degree in Mechanical, Industrial, or other Engineering Science.
  • 5 years of engineering experience in a manufacturing setting, including state of the art manufacturing technology/concepts and cost reductions.
  • Experience in an ISO13485/GMP environment.
  • Engineering experience with medical devices.
  • Manufacturing process design and validation.
  • Manufacturing equipment and fixture/gauge design.
  • Lean manufacturing experience.
  • Team dynamic skills including communication, accountability, decision-making, feedback, meeting management, and managing conflict.
  • Knowledge of DOE, SPC, FMEA, GMP, QSR.
  • Knowledge of statistical software.
  • Knowledge of materials and related processes.
  • Project management experience.
  • Manufacturing automation experience, including electronic visual inspection.
  • Proficiency in 3D CAD software (i.e., ProE, Unigraphics, Solidworks, etc.).
  • Excellent communication and influencing skills.
  • High level of energy, personal accountability, and integrity.
  • Highly detail oriented; checks own work, keeps accurate records, organizes information effectively.
  • Ability to tolerate ambiguity, multiple priorities, and short deadlines.

Nice-to-haves

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

Benefits

  • Medical insurance options
  • Dental insurance options
  • Vision insurance options
  • Life insurance options
  • 401(k) retirement plan with employer match
  • Profit sharing
  • Short- and long-term disability insurance
  • Paid time off
  • Holiday pay
  • Employee Appreciation events
  • Volunteer Opportunities
  • Training and Development opportunities
  • Tuition Reimbursement
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service