Principal Manufacturing Engineer

Position Summary

The Principal Manufacturing Engineer position works with our contract manufacturers to develop and implement optimal, cost-effective manufacturing value engineering principles, processes and methods in accordance with product specifications and medical device quality standards.

This position is responsible for recommending and implementing improvements to production processes, methods and controls; coordinates manufacturing launch for new and revised products; develops incoming receiving test processes and develops dock to stock processes and qualifications.

Job Responsibilities

  • Responsible to work with suppliers to create manufacturing and inspection procedures.
  • Identify, develop and implement process improvements.
  • Design and develop test fixtures and automation.
  • Develop mechanical and electronics procedures and tools.
  • Improve durability and reliability of design, as well as provide design changes for sustaining and continuation engineering.
  • Work with operations team to ensure finished products meet customer specifications.
  • Work with suppliers to solve production related issues.
  • Participate in production equipment selection and assessment.
  • Develop and complete IQ, OQ and PQ for production equipment, fixtures and tooling.
  • Develop process controls for production equipment.
  • Develop, write and implement equipment standards.
  • Specify maintenance and calibration requirements.

Required Qualifications

  • Bachelor's degree in Engineering or related field.
  • 8+ years medical device experience or equivalent experience in a regulated industry.
  • Demonstrated working knowledge of ISO 13485 Quality System Medical Devices.
  • Proven ability to work effectively in a team environment through conflict resolution and negotiations.
  • Working knowledge of statistical methodologies, quality control and manufacturing tools, such as applied statistics, lean manufacturing, Six Sigma, etc.
  • Excellent written and verbal communication skills.
  • Ability to build relationships and work well with others.
  • Able to be organized and detailed with a variety of tasks.

Preferred Qualifications:

  • Electromechanical education and experience, firmware understanding is a benefit.
  • Broad experience in multiple manufacturing environments.
  • Experience handling Non-Conformances, CAPAs, SCARs, Complaints and Change Orders.
  • Knowledge and experience with computers and engineering CAD and analysis software (Solid Edge, SolidWorks etc.).
  • Knowledge of production and material handling equipment.
  • Knowledge of measuring and inspection tools.
  • Knowledge of logistics.

Physical Requirements:

  • The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
  • While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to use a computer, and communicate with peers and co-workers

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