Senior Manufacturing Engineer

Senior Manufacturing Engineer – Operations Engineering (Individual Contributor)

Location: Mahwah, NJ (Onsite)

Position Overview

The Senior Manufacturing Engineer will support Operations Engineering Instrument Services Department (ISC) by executing product transfer and process implementation activities within manufacturing and service operations. This individual contributor role is responsible for ensuring site readiness, maintaining engineering documentation, and supporting inspection and process validation activities in a regulated medical device environment.

The ideal candidate will bring strong technical fundamentals in manufacturing engineering, validation, inspection systems, and cross‑functional execution, with the ability to support multiple engineering workstreams to meet project timelines and compliance requirements.

Key Responsibilities

• Support Operations Engineering through the planning, coordination, and execution of product transfer and process implementation activities within manufacturing and service operations.
• Assist in the development and execution of engineering deliverables related to product transfers, including process validation activities, inspection readiness, and documentation updates.
• Ensure compliance with applicable quality standards, regulatory requirements, and internal procedures throughout process implementation and transfer phases.
• Evaluate manufacturing and inspection processes to ensure efficiency, robustness, cost‑effectiveness, and compliance with established standards.
• Collaborate cross‑functionally with Manufacturing Engineering, Quality Engineering, Operations, and external suppliers to support successful execution of project timelines and deliverables.
• Provide technical support for process development, equipment readiness, inspection methods, and risk mitigation.
• Support site readiness activities by maintaining and updating engineering documentation, including process flows, risk assessments, work instructions, and routers.
• Enable inspection readiness through development and support of measurement systems, gage and fixture management (including enrollment and calibration), data analysis, and technical training as required.
• Support updates to manufacturing systems, labeling, and process changes in alignment with quality and regulatory requirements.
• Partner closely with technical subject matter experts, supporting execution, driving task completion, and ensuring consistency, accuracy, and traceability across all engineering activities.

Required Qualifications

• Bachelor’s degree in Engineering (Manufacturing, Mechanical, Industrial, Biomedical, or related engineering discipline).
• Minimum 5 years of manufacturing engineering experience, preferably in a regulated environment such as medical devices, pharmaceuticals, biotech, or aerospace.
• Solid understanding of manufacturing and inspection process development, including process flows, work instructions, and engineering documentation control.
• Experience supporting process validation activities (e.g., IQ/OQ/PQ concepts) and inspection readiness for product transfers.
• Working knowledge of quality systems and regulatory requirements (e.g., FDA, ISO 13485, GMP).
• Experience with risk management tools, such as FMEA or similar risk assessment methodologies.
• Hands-on experience with gage and fixture management, including calibration, measurement system concepts, and inspection tooling.
• Strong cross‑functional collaboration skills with the ability to work effectively with Engineering, Quality, Operations, and suppliers.
• Demonstrated ability to manage multiple tasks, support project timelines, and deliver accurate, well‑documented engineering outputs.

Preferred / Additional Technical Qualifications

• Experience with measurement system analysis (MSA) and data analysis to support inspection readiness and process capability.
• Familiarity with GD&T fundamentals and interpretation of engineering drawings.
• Experience supporting manufacturing system updates, routing changes, and labeling updates.
• Prior experience supporting product transfers between sites or from development into manufacturing.

This is a Contract position based out of Mahwah, NJ.

The pay range for this position is $50.00 - $65.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Mahwah,NJ.

This position is anticipated to close on Apr 30, 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.

Salary : $50 - $65