Full Time
Big Lake, MN
Posted 3 weeks ago

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Manufacturing Engineer to join our organization. Founded in 1988, TOMZ continues to be a family owned and operated organization which offers competitive compensation and excellent benefits. Those include 401k, health/dental, vision, and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

Reporting to the Engineering Manager, this position will have direct responsibility for developing and implementing robust cost-effective manufacturing processes and methods, recommending improvements to sustained production processes, methods, and controls, and coordinating the launch of new products into volume production. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices.

Essential Functions

  • Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
  • Support Production in reducing / eliminating equipment and tooling downtime or scrap.
  • Perform tool life studies to drive efficiency and cost savings opportunities.
  • Conduct Process Capability studies during manufacturing processes to support achieving objectives.
  • Collaborates with cross-functional teams during the production transfer phase to establish and launch robust, mid to high volume processes.
  • Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products.
  • Prepares engineering change orders and coordinates the deployment of changes including training operation team members.
  • Develop and improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products.
  • Develop and qualify various tools and equipment required for manufacturing processes.
  • Performs product and process analysis for cost reduction, quality improvement and improved efficiency.
  • Utilizing tools associated with risk management (e.g. PFMEA) to identify potential risks and the associated corrective actions.
  • Supporting required equipment qualification and process validations (IQ, OQ and PQ).
  • Troubleshoot manufacturing processes when defects occur. Leads investigations to determine root cause and implement effective containment and countermeasures.
  • Train Engineering and Operations personnel as required on manufacturing processes/equipment.
  • Disposition non-conforming products and develop re-work procedures.
  • Leads Kaizen events and drives continuous improvement efforts.
  • Performs other duties as assigned.

Qualifications:

Education

  • Minimum of a bachelor’s degree in an engineering discipline or equivalent experience

Experience

  • Minimum of 5 years’ experience within a regulated industry (preferably in a Medical Device or Aerospace contract Manufacturer)

Qualifications

  • Must possess a high attention to detail.
  • Ability to read drawings and specifications containing GD&T
  • Proficiency in SolidWorks
  • Proficient in the use of Microsoft Office, and Adobe products.
  • Solid knowledge of GMP and ISO 13485 regulations
  • Experience associated with continuous improvement activities, including participations and/or facilitating Kaizen events using lean manufacturing principles.
  • Ability to work in a fast-paced Medical Device Manufacturing environment with high output efficiency and impeccable quality standards.

Preferred Skills

  • Exhibit good time management skills and ability to prioritize workflow throughout the day.
  • Motivated self-starter with ability to work both independently and as part of a team.
  • Strong verbal and written English language communication skills.

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is frequently required to stand, and/or walk.  The employee must occasionally lift and/or move up to 30 pounds while moving components, fixtures, equipment and/or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

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