Project Manager

Actalent; Noblesville (IN); On-site; USD 79,000 - 93,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

PTO and vacation

Job summary

Actalent is seeking a Project Manager to lead automation, equipment, and smart manufacturing projects in a regulated medical device environment in Noblesville, IN. You will oversee projects from concept to validation and handoff, ensuring on-time delivery, budget adherence, and regulatory compliance, while driving quality and efficiency improvements.

The role requires coordinating cross-functional teams, managing suppliers, and delivering scalable automation solutions with strong governance and

Qualifications

• Bachelor's degree in engineering, manufacturing, or a related technical field.
• 6-8 years project management experience in a manufacturing environment.
• 5+ years leading automation and equipment capital projects in regulated environments.
• Experience working with consultants.
• Proven ability to manage multiple projects with budgets, schedules, and risks.
• Experience with robotics, PLCs, vision systems, automation equipment, and smart manufacturing.
• Knowledge of FDA QSR (21 CFR Part 820), ISO, and related medical device regulations.
• Excellent written and verbal communication in English.

Responsibilities

• Lead automation and equipment capital projects from concept through installation, validation, and production readiness.
• Develop and manage project plans, timelines, budgets, resources, risks, and deliverables.
• Coordinate cross-functional teams including Engineering, Manufacturing, Quality, Validation, Regulatory Affairs, Supply Chain, and Operations.
• Manage relationships with equipment manufacturers, system integrators, and external suppliers.
• Drive project governance with reviews, status updates, and risk assessments.
• Track and report project performance, financial results, savings, ROI, and KPIs.
• Ensure projects are completed safely, within scope, on schedule, and within budget.
• Lead implementation of automated manufacturing systems (robotics, PLCs, vision systems, etc.).
• Support MES, SCADA, IIoT deployments and data analytics.
• Collaborate to identify automation opportunities to improve quality and efficiency.
• Facilitate FAT, SAT, installation, commissioning, and startup with proper documentation.
• Ensure compliance with regulatory and quality requirements including FDA QSR and ISO.
• Oversee validation (IQ/OQ/PQ) planning and execution and change control activities.
• Maintain audit-ready project documentation.
• Champion Lean Six Sigma and continuous improvement initiatives.
• Promote DFM and DFA principles in new technologies.

Skills

PM methodologies

Leadership

Budgeting

Regulatory compliance

Vendor mgmt

Automation tech

Education

Bachelor's degree in engineering/manufacturing

Tools

MES

SCADA

IIoT

Job description

Job Description

The Project Manager is responsible for leading and executing automation, equipment, and smart manufacturing projects within a regulated medical device manufacturing environment. This role oversees projects from concept through implementation, validation, and operational handoff, ensuring on‑time delivery, budget adherence, regulatory compliance, and achievement of business objectives. The Project Manager partners with cross‑functional teams, suppliers, and stakeholders to develop and deploy innovative automation solutions that improve quality, efficiency, traceability, and manufacturing performance.

Job Title: Project Manager

The Project Manager is responsible for leading and executing automation, equipment, and smart manufacturing projects within a regulated medical device manufacturing environment. This role oversees projects from concept through implementation, validation, and operational handoff, ensuring on‑time delivery, budget adherence, regulatory compliance, and achievement of business objectives. The Project Manager partners with cross‑functional teams, suppliers, and stakeholders to develop and deploy innovative automation solutions that improve quality, efficiency, traceability, and manufacturing performance.

Responsibilities

• Lead automation and equipment capital projects from concept development through installation, validation, and production readiness.
• Develop and manage project plans, timelines, budgets, resources, risks, and deliverables to ensure successful project execution.
• Coordinate cross‑functional teams including Engineering, Manufacturing, Quality, Validation, Regulatory Affairs, Supply Chain, and Operations.
• Manage relationships with equipment manufacturers, system integrators, and external suppliers to ensure project requirements are met.
• Drive project governance by facilitating project reviews, status updates, risk assessments, and stakeholder communications.
• Track and report project performance, financial results, savings, return on investment, and key performance indicators (KPIs).
• Ensure projects are completed safely, within scope, on schedule, and within budget.
• Lead the implementation of automated manufacturing and assembly systems, including robotics, PLCs, machine vision systems, motion control technologies, and automated inspection equipment.
• Support deployment of smart manufacturing technologies, including Manufacturing Execution Systems (MES), SCADA platforms, Industrial Internet of Things (IIoT) solutions, and data analytics tools.
• Collaborate with engineering and manufacturing teams to identify automation opportunities that improve quality, throughput, traceability, and operational efficiency.
• Facilitate equipment design reviews, factory acceptance testing (FAT), site acceptance testing (SAT), installation, commissioning, and startup with oversight of engineering documentation, project records, specifications, procedures, and standard work.
• Ensure all projects comply with applicable regulatory and quality requirements, including FDA Quality System Regulations and internal quality standards.
• Oversee validation planning and execution activities, including IQ, OQ, and PQ protocols, ensuring validated systems are production‑ready.
• Partner with Quality and Validation teams to support process validation, equipment qualification, and change control activities.
• Ensure project documentation is complete, accurate, and audit‑ready.
• Champion Lean Manufacturing, Six Sigma, and continuous improvement initiatives throughout project execution.
• Promote Design for Manufacturability (DFM) and Design for Assembly (DFA) principles when implementing new technologies and processes.
• Identify opportunities to improve project management processes, manufacturing systems, and operational performance.
• Support strategic manufacturing initiatives and perform other duties as assigned.

Essential Skills

• Bachelor's degree in Engineering, Manufacturing, Project Management, or a related technical field.
• Minimum 6-8 years of progressive project management experience in a manufacturing environment.
• Minimum 5 years of experience leading automation and equipment capital projects, including line transfers, within the medical device industry or a closely related regulated environment such as Pharmaceuticals, Aerospace, or Automotive.
• Experience working with consultants.
• Demonstrated experience managing multiple projects simultaneously, including budgets, schedules, resources, and risk mitigation.
• Experience implementing automation technologies such as robotics, PLCs, vision systems, automated assembly equipment, and smart manufacturing solutions.
• Strong knowledge of project management methodologies and tools.
• Excellent verbal and written communication skills, including the ability to prepare complex reports, business presentations, and executive communications.
• Experience with medical device process validation, equipment qualification (IQ/OQ/PQ), and change management.
• Strong knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO, and other applicable medical device regulations.
• Ability to speak, read, write, and understand English.

Additional Skills & Qualifications

• Project Management Professional (PMP) certification or equivalent project management certification preferred.
• Experience with MES, SCADA, IIoT, data analytics, and Industry 4.0 technologies preferred.
• Lean Six Sigma Green Belt, Black Belt, or equivalent continuous improvement certification preferred.

Work Environment

This position requires onsite work with first shift hours, offering some flexibility in exact hours. The project will last at least 2 years, with a strong possibility for extension or conversion to a direct employee. Occasional travel to other locations, such as El Paso or Mexico, may be required, but it will not be part of the regular schedule.

Job Type & Location

This is a Contract position based out of Noblesville, IN.

Pay And Benefits

The pay range for this position is $57.69 - $67.31/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job‑related factors.

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)

Application Deadline

This position is anticipated to close on Nov 10, 2026.

Workplace Type

This is a fully onsite position in Noblesville, IN.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.