Principal Process Development Engineer

Company: Shelby American, Inc.
Location: Minneapolis
Posted on: March 29, 2025

Job Description:

DescriptionJob SummaryThe Principal Process Development Engineer position leads the development, improvements and implementation of optimal cost-effective and compliant manufacturing processes and methods in accordance with product specifications and quality standards.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 can capably produce product that meets the design requirements.
• Prepares and presents detailed plans necessary to complete assigned projects.
• Develops schedule milestones, coordinates resources, 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.
• Writes engineering change orders to process changes to manufacturing documents, drawing, and Bill of Materials.
• Supports company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements.
• Recommends, supports and implements improvements, modifications, or additions that will improve work processes.
• Takes the lead in analyzing the need for new process development and to meet company needs including specifying, ordering, installing and validating new equipment or processes.
• Prepares justification for capital expenditures.
• Aids in production transfers from R&D to manufacturing.
• Proposes potential new manufacturing technologies, including automation and new equipment.
• Contributes to the definition, development and implementation of LEAN manufacturing initiatives.RequirementsEducation, Experience, Required Skills
  • Bachelor's degree in engineering or related field
  • 10+ years related experience in medical device industry with a focus in 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 using influence to affect project and organizational success
  • Experience with programs including SolidWorks and/or Mastercam
  • MS Office Proficiency
  • Ability to handle and be trusted with confidential and/or sensitive informationPhysical 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.Summary of Benefits
      • Group health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan), and Flexible Spending Accounts.
      • Company-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Kavira (requires participation in medical plan).
      • Voluntary, employee-paid benefits: Employee Supplemental Life & AD&D, Spouse and Dependent Life & AD&D, Short Term Disability (STD), Accident, Critical Illness, and Hospital Indemnity, Employee Assistance Program.
      • Flexible Time Off Program
      • Paid Parental Leave
      • Paid Holidays
      • Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.Compensation
        • The typical base pay range for this role is between $130,000-160,000/year. Compensation may vary based on individual job-related knowledge, skills, expertise, and experience. This position is eligible for a discretionary annual incentive program driven by organization and individual performance.
        • 401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.
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Keywords: Shelby American, Inc., Minneapolis , Principal Process Development Engineer, Engineering , Minneapolis, Minnesota