Astrix

Compensation

Full Description

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 worlds most complex medical devices. - Salary: $100-120K - Location: Linden, NJ (onsite) SUMMARY: The Process Engineer will work with the validation engineers and other cross functional teams to ensure the successful launch of various projects. ESSENTIAL DUTIES AND RESPONSIBILITIES: • 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. QUALIFICATIONS: • 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 requires 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. COMPETENCIES: • 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. Generate suggestions for improving work. Develop innovative approaches and ideas. Presents ideas and information in a manner that gets others’ attention.