Principal Process Development Engineer - IPG

RESOLUTION MEDICAL LLC-posted 3 months ago
$135,000 - $185,000/Yr
Full-time • Senior
Minneapolis, MN
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The Principal NPI/Process Development Engineer position leads the development, improvements and implementation of optimal cost-effective designs and associated processes that meet the high rigor of product requirements and exceptional quality standards. This role will work specifically with active implantable products.

  • Works independently to drive project completion by developing the processes used to manufacture component, sub-assemblies, and FG devices.
  • Provides leadership and mentors 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.
  • Bachelor’s degree in engineering or related field.
  • 10+ years related experience in medical device industry with a heavy focus on product or process development of Active Implantable Devices.
  • Strongly preferred experience in Neuromodulation Devices (IPGs or Leads).
  • Experience with pacemakers, cardiac monitors, brain computer interface, etc. also considered.
  • Extensive experience with process validations for laser welding, header attachment, and internal moisture (bake) and Test Method Validation for Helium Leak Testing.
  • 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 information.
  • 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.
  • 401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.
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