• NPI Process Engineer

    Astrix Technology (Rahway, NJ)


    NPI Process Engineer

     

    Engineering

    Rahway , New Jersey, NONE

    + Added - 05/01/2026

     

    Apply for Job

     

    - **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 worlds most complex medical devices._

     

    **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:

    1. Analytical: Synthesizes complex or diverse information. Collects and researches data. Uses intuition and experience to compliment data. Designs workflows and procedures.

    2. Project Management: Develops project plans. Coordinates projects. Communicates changes and progress. Completes projects on time and budget. Manages project team activities.

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    INDBH

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.