Project Manager/engineer

Job Title:

Project Manager 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.

Job 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. Works in a hands-on environment able to lift and move up to 25 lbs on a routine basis. 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) This position is moving extremely fast as this is an urgent need for the client.

If interested, please send over your most up to date resume to ktrivigno @astoncarter.com along with your availability for a 10-minute phone call. 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 27, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.