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Process Development Engineer II

nexternMaple Grove, Minnesota, United States
On-site Full-time $80K/yr - $95K/yr

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Experience Level

Experience

Qualifications

Qualifications:Bachelor’s degree in Mechanical Engineering or Biomedical Engineering with over 5 years of experience in process development/improvement. Proven track record of cross-functional teamwork in technically challenging environments. Ability to develop processes from initial concept through to production. Self-motivated individual capable of driving projects to completion through collaborative efforts. Demonstrated capability to innovate and integrate solutions into processes and products. Knowledge of DFM, medical device design control/quality systems, and the product development process (PDP). Exceptional written and verbal communication skills. Strong organizational, analytical, and problem-solving skills. Ability to prioritize and manage workflow efficiently. Demonstrated project planning and organizational skills. Sound judgment with the ability to make timely and informed decisions. Creative, adaptable, and a collaborative team player.

About the job

As a Process Development Engineer II at nextern, you will play a crucial role in spearheading the development of intricate technologies and ensuring a seamless transition of products into production. Your expertise will drive innovation and efficiency in our manufacturing processes.

Key Responsibilities:

  • Interpret design specifications and convert them into robust manufacturing procedures that ensure the quality and reliability of finished products.
  • Evaluate process capabilities, identify opportunities for improvement, and implement enhancements in existing manufacturing processes.
  • Utilize your technical knowledge to innovate, design, and refine processes, tooling, and equipment.
  • Define and document deliverables in accordance with individual design and development plans.
  • Establish and release protocols for installation, performance, and operational qualifications (IQ/PQ/OQ) along with comprehensive reports.
  • Provide Design for Manufacturing (DFM) insights to enhance assembly and component specifications.
  • Create and compile training materials; lead training sessions to ensure team competency.
  • Collaborate with cross-functional teams to refine product design and tooling processes for optimal production efficiency.
  • Engage with external vendors to finalize product specifications; manage the procurement of equipment, materials, and parts, and assess products to verify adherence to specifications and quality standards.
  • Estimate production timelines, staffing needs, and associated costs to inform management decision-making.
  • Project future manufacturing requirements and potential developments.
  • Analyze data for process investigations, productivity enhancements, cost evaluations, and regulatory compliance; document and communicate findings effectively.
  • Perform other related duties as assigned by management.

About nextern

nextern is at the forefront of technology innovation, specializing in the development of cutting-edge solutions that enhance production processes across various industries. Our commitment to quality and efficiency drives our mission to deliver exceptional products and services to our clients.

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