Job Information
Actalent Project Manager in Phillipsburg, New Jersey
Description
The Project Manager coordinates and oversees medical device projects from design review through production implementation. This role manages schedules, resources, compliance, verification and validation, and cross‑functional communication while ensuring adherence to FDA, ISO, and GMP requirements. The Project Manager interfaces directly with customers, leads risk management and corrective actions, monitors production efficiency, and supports manufacturing operations in a regulated environment.
Duties and Responsibilities:
Possesses knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and international medical device regulations (MDR).
Thorough understanding of Design Control and Engineering Change Procedures as they relate to Class I and Class II Medical Devices.
Ensures compliance to QSR and GMP and in all assigned areas.
Manages new product development efforts by:
· Coordinating other departmental assignments
· Preparing and managing project schedules
· Facilitating internal and external communications.
Responsible for development, review and approval of Design, Development, and Process verifications and validations.
Interfaces with customers to capture design intent, recommend design improvements, communicates schedules and resolve any issues that arise.
Reviews sales order status reports to assess department’s capacity to fill customer demand.
· Takes action as required to satisfy customer expectations.
Creates and maintains quotes, timelines and production schedules to meet customer demand.
Evaluates cost reporting, takes corrective action to increase efficiencies, reduce downtime and eliminate material waste.
Monitors production and scrap reporting to ensure accurate information is being entered into Enterprise Resource Planning (ERP) system.
Leads root cause investigations, implements corrective actions, and follows through on effectiveness checks.
Works closely with internal departments (Design, Production, Quality) to resolve in-house and supplier quality issues.
Maintains the functional status of equipment in the department, and works with engineering and maintenance to repair, upgrade,
or replace equipment as required. Recommends technology and equipment upgrades.
Utilizes Quality tools such as FMEA, Control Plan, and Process Flow.
Maintains working knowledge of SPC and data analysis.
Develops and implements inspection plans.
Fulfills duties of Production Manager as needed or works closely with Production Manager to ensure compliance with the schedule.
Possesses competent technical writing skills.
Works in a hands-on environment able to lift and move up to 25 lbs on a routine basis.
Follows company policies and maintains confidentiality of the company.
Additional Skills & Qualifications
Bachelor's in Engineering or related field
Experience in ISO-regulated or medical device manufacturing environments
Proficiency in Microsoft Office
Strong communication skills
Experience supervising engineers and production personnel
Familiarity with measuring equipment (micrometers, comparators, fixtures)
Job Type & Location
This is a Permanent position based out of Phillipsburg, NJ.
Pay and Benefits
The pay range for this position is $90000.00 - $110000.00/yr.
Medical, prescription, dental & vision insurance 401(k) retirement plan with employer match Paid holidays Vacation time Paid Time Off (PTO) Company‑paid life insurance Disability insurance Employee assistance & telemedicine services
Workplace Type
This is a fully onsite position in Phillipsburg,NJ.
Application Deadline
This position is anticipated to close on Mar 16, 2026.
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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.