Process Development Engineer II

Nextern•Maple Grove, MN

6d•$80,000 - $95,000

About The Position

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

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

Nice To Haves

Working knowledge of data collection, data analysis, evaluation, and scientific method

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.