Process Development Engineer II - Maple Grove - Nextern Inc.

    Nextern Inc.
    Nextern Inc. Maple Grove

    5 days ago

    $95,000 - $145,000 (USD) per year *
    Description

    The Process Development Engineer II works cross-functionally to lead process development of complex technologies and ensures effective transfer of product into production.
    DUTIES AND RESPONSIBILITIES:

    • Analyze design specifications and translate the requirements into robust manufacturing procedures to achieve quality and reliability of finished products.
    • Assesses process capabilities, prioritizes process improvement opportunities, and implements process improvements on existing manufacturing processes.
    • Applies technical knowledge to innovate, design, and develop processes, tooling, and equipment.
    • Defines and releases the deliverables as defined by individual design and development plans.
    • Defines and releases installation, performance and operational qualification (IQ/PQ/OQ) protocols and reports.
    • Provides design for manufacturing (DFM) input to the assembly and component specifications.
    • Compiles and writes training materials; develops and conducts training sessions.
    • Works collaboratively with appropriate departments/teams to develop product design and tooling processes to ensure efficient production methods.
    • Interfaces with outside vendors to determine product specifications; coordinates purchase of equipment, materials, and/or parts; evaluates products to ensure they meet specifications and quality standards.
    • Estimates production times, staffing requirements, and related costs to provide information for management decisions.
    • Estimates future manufacturing requirements and potential.
    • Analyzes data for process investigations, productivity improvements, cost analysis, regulatory filings; documents and communicates results.
    • Performs other related duties as assigned by management.
    Requirements
    QUALIFICATIONS:
    • BS in Mechanical Engineering or Biomedical Engineering and 5+ years of process development/ improvement experience
    • Demonstrated cross functional teamwork in technically demanding environment
    • Demonstrated ability to develop processes from concept to production
    • Highly motivated individual that can independently drive deliverables to completion through collaboration among team members.
    • Demonstrated ability to develop and drive innovative solutions into processes and products.
    • Understanding of DFM, medical device design control / quality systems and the product development process (PDP).
    • Excellent written and oral communication skills
    • Strong organizational, problem-solving, and analytical skills
    • Ability to manage priorities and workflow
    • Demonstrated ability to plan and organize projects
    • Good judgement with the ability to make timely and sound decisions
    • Creative, flexible, and innovative team player
    Preferred Qualifications:
    • Working knowledge of data collection, data analysis, evaluation, and scientific method
    Benefits
    Nextern offers excellent benefits to fuel you in building a fulfilling life & career:
    • Employer subsidized health insurance for employees
    • Employer paid dental insurance
    • Employer HSA contribution
    • 401k plan with a company match
    • 9 paid holidays (including your birthday) + PTO and Personal days
    • Gym membership subsidy
    • Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance
    Salary Range for This Position: $80,000 - $95,000
    * This salary range is an estimation made by beBee
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