Process Engineer​/Project Manager; medical device

Process Engineer / Project Manager (Medical Device)

Base pay range: $/yr – $/yr

Location: Linden, NJ (onsite)

The Process Engineer will work with the validation engineers and other cross-functional teams to ensure the successful launch of various projects.

• 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, including but 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, including but not limited to.
• Understand customer qualification requirements and oversee execution of varying complexity (e.g., First Article Inspections, OQ, PQ, PFMEA, Control Plans, MSA, 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.
• 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 requiring 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 complement 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 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 captures attention.