Senior Process Development Engineer

Date Posted: Active 2 days ago
Salary:
Fridley, MN 55421

Job Description

Senior Process Development Engineer

Job Summary

The Senior Process Development Engineer works cross-functionally to lead process development of complex medical devices and ensures effective transfer of designs into production.

Essential Functions

  • Works independently to drive project completion by developing the processes used to manufacture component, sub-assemblies, and FG devices.
  • Provides leadership and coaches less experienced engineers and technicians.
  • Acts as the liaison between development and operations.
  • Advocates for the process to ensure they are repeatable and the process can capability produce product that meets the design requirements.
  • Prepares and presents detailed plans necessary to complete assigned projects.
  • Develops schedule milestones, coordinates manpower, facility and equipment for assigned projects.
  • Assists in improving the system of production controls, standard operating procedures, safety, quality control and training.
  • Prepares and maintains detailed layouts of buildings and equipment.
  • Coordinates the manufacturing launch of new/revised products including establishing goals, training team members and evaluating results.
  • Designs, develops and tests as well as sources various tools, machinery and equipment for recommended manufacturing methods while providing ROI analysis.
  • Performs product/process analysis for production and quality metrics.
  • Write engineering change orders to process changes to manufacturing documents, drawing, and Bill of Materials.
  • Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements.
  • Performs other related duties as assigned by management.

Education, Experience, Required Skills

  • Bachelor’s degree in related field (equivalent work experience may be considered)
  • 5+ years related experience as an individual contributor, with strong strategic focus in the areas of Product and Process development
  • Demonstrated ability to independently develop medical device manufacturing processes from concept to production.
  • Experience with medical device Design For Manufacturing, design control, quality systems and product development phases
  • Demonstrated ability to implement change in a way that positively impacts overall department and company performance
  • Must be able to handle multiple projects simultaneously
  • Must excel at working in a team environment with a high level of people/interpersonal skills and demonstrated ability to cross functionally drive results
  • Experience with programs including SolidWorks and/or Mastercam
  • MS Office Proficiency

Physical Requirements

  • Prolonged periods of sitting at a desk and working on a computer.
  • Must be able to lift up to 25 pounds at times.
  • Must have excellent hand-eye coordination.
  • Ability to differentiate between colored wires, tabs, and electronic components.
  • Must wear gown, gloves, and ear protection if applicable.

Authority and Responsibility

  • Accountable for their performance and will have authority as delegated to complete their tasks and objectives.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Job Type: Full-time

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Employee assistance program
  • Flexible schedule
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Vision insurance

Schedule:

  • 8 hour shift
  • Monday to Friday

Education:

  • Bachelor's (Preferred)

Experience:

  • Medical Device: 5 years (Required)

Work Location:

  • One location

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Job Detail

  • Job Id
    e11fa34cd053644b
  • Location
    Fridley, MN 55421
  • Company
  • Type
    Private
  • Employment Status
    Permanent
  • Positions
    Available
  • Career Level
    Experience
  • Gender
    Male/Female

Contact

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