NPI Process Engineer

Compensation & Location

Salary: $120-145K + annual bonus

Location:

Linden, NJ (onsite)

Our client, a global leader in the medical technology world is looking for a Process Engineer to join their growing team. This is a great opportunity to work with a company that provides specialty medical technology solutions for some of the world's most complex medical devices.

• Reviews and thoroughly understand product functional and design specifications.
• Work with Cross Functional Team to develop robust manufacturing and inspection methods to ensure successful launch of NPI projects.
• Work with the NPI Validation Engineers to help prepare new large-scale projects for successful transfer into production. This includes, but is not limited to:
• Work with Customers to ensure design requirements are understood and met.
• Convey project timelines and requirements to the internal team.
• Work with operational and quality leadership teams to ensure resource requirements are understood and met for each project.
• Ensure proper communication and oversight over projects in production. This can include, but is not limited to:
• Understand customer qualification requirements and oversee execution of varying complexity. These activities could include, but are not limited to:
• First Article Inspections, Operations Qualification (OQ), Performance Qualification (PQ), PFMEA, Control Plans, Measurement System Analysis (MSA), Customer Production Part Approval Process (PPAP).
• Work with NPI Engineering team to perform process characterization studies for ensuring robust quality and/or meeting cost targets. Perform statistical process control analysis as required.

• Bachelor’s Degree (B.S.) in a related field.
• PMP Certification is a plus.
• 10-15 years’ experience.
• Commitment to excellence and high standards.
• Excellent written and oral communication skills.
• Strong organizational, problem-solving, and analytical skills.
• Ability to manage priorities and workflow.
• Acute attention to detail.
• Demonstrated ability to plan and organize projects.
• Working knowledge and understanding of the basic principles, theories, concepts, and practices in the applicable area of engineering/technical specialization.
• Worked in a highly regulated industry;
  Medical Device experience preferred.
• Experience in contract manufacturing.
• Experience working with large scale projects that require capex expenditure, process development, and extensive qualification requirements.
• Experience working directly with external vendors.
• Experience working with a cross functional team to ensure project success.
• Experience working with customers to ensure understanding of project requirements and set project expectations.

• Analytical:
  Synthesizes complex or diverse information. Collects and researches data. Uses intuition and experience to compliment data. Designs workflows and procedures.
• Project Management:
  Develops project plans. Coordinates projects. Communicates changes and progress. Completes projects on time and budget. Manages project team activities.
• Planning/Organizing:
  Prioritizes and plans work activities. Uses time efficiently. Plans for additional resources. Sets goals and objectives. Organizes or schedules other people and their tasks. Develops realistic action plans.
• Quality:
  Demonstrates accuracy and thoroughness. Looks for ways to improve and promote quality. Applies feedback that is given to improve performance. Monitors own work to ensure quality.
• Adaptability:
  Adapts to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent changes, delays, or unexpected events.
• Innovation:
  Displays original thinking and creativity. Meets challenges with resourcefulness. Generates suggestions for improving work. Develops innovative approaches and ideas. Presents ideas and information in a manner that gets others’ attention.