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We are hiring for a Process Engineer

Position Overview

We are seeking an experienced and driven Process Engineer to lead the integration of new products, optimize manufacturing processes, and manage scale-up initiatives from R&D to full production. This role plays a critical part in ensuring operational efficiency, product quality, and regulatory compliance. The ideal candidate will have a strong background in process validation, lean manufacturing, and cross-functional project leadership within a regulated environment.

Key Responsibilities

+ Collaborate with the Project Management Office to develop and execute detailed timelines for new product introductions.

+ Mentor junior integration engineers and lead cross-functional project teams.

+ Guide teams through decision-making processes to meet operational goals such as yield improvement and scrap reduction.

+ Design and optimize manufacturing processes, procedures, and production layouts.

+ Identify project risks and implement mitigation strategies.

+ Resolve technical and operational issues impacting project success.

+ Drive product cost improvements using Lean Six Sigma methodologies.

+ Support equipment qualification, sterilization validation, and packaging design/validation.

+ Ensure compliance with company quality policies and regulatory standards through training and documentation.

+ Identify and address product, process, and quality system issues.

+ Lead the development and execution of validation strategies.

+ Review and approve Engineering Change Orders, Master Validation Plans, Validation Protocols, Batch Records, and Process Risk Analyses.

+ Approve Purchase Orders related to Operations.

Required Qualifications

+ Bachelor’s degree in Chemical, Mechanical, Industrial, or Biomedical Engineering with a minimum of 10 years of experience in a medical device or science-related field, or a Master’s degree with at least 7 years of relevant experience.

+ Extensive experience in process engineering, process validation, and scaling products from R&D to manufacturing.

+ Proficiency in process validation optimization experiments.

+ organizational, leadership, and interpersonal skills.

+ Excellent written, verbal, and presentation communication abilities.

+ Analytical problem-solving skills and data-driven decision-making capabilities.

+ Experience in medical product manufacturing and FDA/ISO regulatory compliance (ISO & 21 CFR 820).

+ Proficiency with SolidWorks or equivalent CAD software.

+ Working knowledge of Six Sigma methodologies and Minitab.

Preferred Skills

+ Experience with biomaterials, cleanroom environments, sterilization processes, and lyophilization.

+ Familiarity with automation and hardware design.

+ Ability to lead complex validation and risk analysis initiatives.

Pay and Benefits

The pay range for this position is $110000.00 - $130000.00/yr.

great benefits / medical benefits start 1st day, 401k requiring no employee contribution, frequent employee activities

Workplace Type

This is a fully onsite position in Paramus,NJ.

Application Deadline

This position is anticipated to close on Oct 10, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.