Demo

Principal Process Development Engineer

Resolution Medical
Minneapolis, MN Full Time
POSTED ON 3/4/2025
AVAILABLE BEFORE 6/4/2025

Job Type

Full-time

Description

Job Summary

The 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.
  • Coaches less experienced engineers and technicians.
  • 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.
  • 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.
  • Recommend, support and implement improvements, modifications, or additions that will improve work processes.
  • Take 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.
  • Prepare justification for capital expenditures.
  • Aid in production transfers from R&D to manufacturing.
  • Propose potential new manufacturing technologies, including automation and new equipment.
  • Contribute to the definition, development and implementation of LEAN manufacturing initiatives.

Requirements

Education, 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 information
  • 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.
  • 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.
  • Salary : $130,000 - $160,000

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