Engineering Project Manager - Hybrid

We are hiring Engineering Project Manager – Hybrid (2 Positions).

Please let me know if you are interested or anyone who might be interested.

Client: Major Medical Device Client

Position: Engineering Project Manager - Hybrid

Duration: 18 Months Contract

Location: Mahwah, NJ 07430

Pay Rate: $75.00-$83.00/ Hr on W2

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Description:

Project Manager (Hybrid – 4 Days Onsite)

MUST HAVES:

• Project Management / Capital Project Execution (2–3 years)
• Demonstrated experience leading cross-functional capital equipment and manufacturing projects from initiation through implementation, including scope, schedule, budget, risk, and stakeholder management.
• Manufacturing or Engineering Experience (5 years)
• Experience working in a manufacturing environment (preferably medical device) with the ability to partner effectively with Engineering, Operations, Quality, and Facilities.
• Communication & Stakeholder Management (5 years)
• Proven ability to drive alignment across cross-functional teams, facilitate decision-making, communicate with all levels of the organization, and manage multiple priorities in a fast-paced environment.

NICE TO HAVES:

• PMP certification
• Experience with capital equipment installations (FAT, SAT, IQ/OQ/PQ or EQ/FAI)
• Experience with Lean Manufacturing or Six Sigma
• Proficiency with Microsoft Project, Smartsheet, or similar project management tools
• PMP certification (preferred)
• Bachelor's degree in Engineering or related technical field
• Relationship building with technical SMEs
• Facilitate cross-functional meetings, drive issue resolution, and provide timely project status updates.
• Demonstrate the ability to identify project risks and implement mitigation plans while maintaining stakeholder alignment.
• Independently manage multiple projects through key milestones while meeting project objectives for safety, quality, schedule, and cost.
• Establish credibility as a trusted partner by driving accountability and effective cross-functional collaboration.
• Identify opportunities to improve project execution, communication, and portfolio management processes while delivering measurable progress against project goals.

Day-to-Day:

• The Project Manager will spend a significant portion of their time coordinating with Engineering, Operations, Quality, Facilities, Supply Chain, and external vendors to ensure projects remain on schedule, within budget, and aligned with business objectives.
• Responsibilities include facilitating project meetings, developing and maintaining project schedules, tracking milestones, managing risks and action items, and communicating project status to stakeholders and leadership.
• The role will also involve supporting equipment installations, qualification activities, production readiness, and issue resolution to ensure successful project execution.

Description:

• The Project Manager will lead complex capital equipment and manufacturing transformation projects from concept through production launch.
• This role is responsible for driving project execution across engineering, quality, operations, supply chain, sourcing, facilities, and external suppliers to ensure projects are delivered safely, on time, within budget, and in compliance with applicable quality and regulatory requirements.
• The ideal candidate will have experience leading large-scale manufacturing equipment implementation projects, managing external vendors, coordinating validation activities, and influencing cross-functional teams in a highly regulated environment.
• This position operates independently with minimal supervision and requires strong leadership, communication, and problem-solving skills. The role does not have direct reports but is expected to lead and influence multidisciplinary project teams.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Project Leadership & Execution:

• Lead multiple capital equipment and manufacturing projects through planning, execution, validation, and production launch.
• Develop and manage project scope, schedule, budget, resource plans, and risk mitigation strategies.
• Drive alignment across engineering, quality, operations, supply chain, facilities, sourcing, and leadership teams.
• Monitor project performance and proactively identify, communicate, and resolve risks, issues, and resource constraints.
• Evaluate and authorize project changes that impact scope, schedule, cost, or technical strategy.

Vendor & Contractor Management:

• Manage equipment suppliers, contractors, and external partners throughout project execution.
• Lead equipment design reviews, technical discussions, and project status reviews.
• Coordinate Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), equipment installation, and commissioning activities.
• Hold vendors accountable to contractual obligations, deliverables, schedules, and performance expectations.

Technical & Validation Coordination:

• Coordinate development of User Requirements Specifications (URS), risk assessments, and project deliverables.
• Partner with technical SMEs to ensure equipment designs meet manufacturing, quality, and operational requirements.
• Support validation planning and execution, including FAT, SAT, IQ/OQ/PQ, engineering studies, and process qualifications.
• Facilitate change control activities and ensure project compliance with applicable procedures and regulatory requirements.

Financial & Strategic Planning:

• Develop and manage capital expenditure requests (CERs), project budgets, and financial justifications.
• Track project spending, forecast capital requirements, and identify opportunities to improve project return on investment.
• Support long-term manufacturing strategy initiatives, insourcing efforts, automation programs, and capacity expansion projects.

Minimum Qualifications:

• Bachelor's degree in Engineering, Manufacturing, Project Management, or related technical field.
• Minimum 4 years of experience leading capital equipment, manufacturing, or engineering projects.
• Experience managing cross-functional teams in a manufacturing environment.
• Experience working with external equipment suppliers and contractors.
• Strong project planning, risk management, and stakeholder management skills.
• Excellent written and verbal communication skills.

Preferred Qualifications:

• Medical device, pharmaceutical, aerospace, or other regulated industry experience.
• Experience with capital equipment implementation and automation projects.
• Experience coordinating FAT, SAT, validation, and equipment qualification activities.
• Knowledge of quality systems, change control, and validation methodologies.
• Experience developing capital requests, business cases, and financial justifications.
• PMP certification or equivalent project management training preferred.

Key Competencies:

• Project Leadership
• Cross-Functional Influence
• Strategic Thinking
• Risk Management
• Vendor Management
• Financial Acumen
• Communication & Executive Presence
• Problem Solving & Decision Making
• Manufacturing & Process Understanding

Regards

Vishnu Das Natesan

dvishnu@radiants.com