Process Engineer

Actalent; Scottsdale (AZ); On-site; USD 100,000 - 130,000; Full time

Job summary

Actalent in Scottsdale, AZ is seeking a Senior Manufacturing Process Engineer to lead development, validation, and optimization of medical device manufacturing processes in a regulated environment. You will drive continuous improvement and support NPI with hands-on floor support and cross-functional collaboration.

The role requires 5+ years in IQ/OQ/PQ validations, ISO/FDA/GMP experience, and a strong background in CAPA, SPC, and Lean Six Sigma.

Qualifications

• 5+ years hands-on IQ/OQ/PQ validations in a regulated manufacturing environment.
• 5+ years experience with ISO standards, FDA 21 CFR Part 820, and GMP requirements.
• Experience with CAPA, root cause analysis, SPC and continuous improvement initiatives.
• Experience in medical device manufacturing or similarly regulated sector.
• Knowledge of Lean Six Sigma in manufacturing.
• Experience supporting New Product Introduction (NPI) and production transfers.

Responsibilities

• Lead development, validation, and optimization of manufacturing processes for medical devices with focus on safety, quality and scalability.
• Plan, execute, and document IQ/OQ/PQ validation activities.
• Drive continuous improvement using Lean Six Sigma to enhance capability and throughput.
• Support NPI and smooth transfer of processes into production.
• Ensure compliance with ISO, FDA 21 CFR Part 820, and GMP requirements.
• Lead CAPA activities with root cause analysis and sustainable fixes.
• Use SPC and data-driven tools to monitor process performance.
• Collaborate with cross-functional teams to resolve production issues.

Skills

IQ/OQ/PQ validation

ISO standards

GMP compliance

CAPA root cause

SPC analysis

Lean Six Sigma

NPI support

Job description

Job Title: Senior Manufacturing Process Engineer

Job Description

The Senior Manufacturing Process Engineer plays a critical role in developing, validating, and optimizing manufacturing processes for medical devices in a regulated environment. This position leads continuous improvement initiatives, supports new product introductions, and ensures compliance with regulatory and quality standards. The role combines strong technical expertise with hands‑on manufacturing experience and close collaboration with cross‑functional teams to enhance product quality, process efficiency, and production scalability.

Responsibilities

• Lead the development, validation, and optimization of manufacturing processes for medical devices, with a focus on safety, quality, and scalability.
• Plan, execute, and document process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Drive continuous improvement initiatives using Lean Six Sigma methodologies to enhance process capability, reduce waste, and improve throughput.
• Support new product introduction (NPI) and new product implementation by developing robust manufacturing processes and ensuring smooth transfer into production.
• Ensure all processes comply with applicable ISO standards, FDA 21 CFR Part 820, and Good Manufacturing Practice (GMP) requirements.
• Lead and support Corrective and Preventive Actions (CAPA) by conducting thorough root cause analysis and implementing effective, sustainable solutions.
• Utilize Statistical Process Control (SPC) and other data‑driven tools to monitor process performance and identify opportunities for improvement.
• Collaborate closely with manufacturing, quality, engineering, and other cross‑functional teams to resolve production issues and improve overall operations.
• Prepare and maintain process documentation, validation protocols, reports, work instructions, and related technical documentation in alignment with regulatory expectations.
• Provide hands‑on support on the production floor to troubleshoot equipment and process issues and to train operations personnel on new or updated processes.
• Contribute to the development and implementation of standard work, best practices, and process control strategies across manufacturing operations.
• Act as a subject matter expert in process validation, regulatory compliance, and continuous improvement to support audits, inspections, and internal reviews.

Essential Skills

• 5+ years of hands‑on experience executing IQ/OQ/PQ process validations in a regulated manufacturing environment.
• 5+ years of experience working with ISO standards, FDA 21 CFR Part 820, and GMP requirements.
• 5+ years of proven experience with CAPA, root cause analysis, Statistical Process Control (SPC), and continuous improvement initiatives.
• Strong background in manufacturing engineering within the medical device industry or a similarly regulated sector.
• Demonstrated expertise in process validation, including planning, execution, analysis, and documentation.
• Practical knowledge of Lean Six Sigma or Six Sigma methodologies applied to manufacturing processes.
• Experience supporting new product introduction (NPI) and new product implementation in a production environment.
• Ability to interpret and apply regulatory and quality requirements to manufacturing processes.
• Strong analytical and problem‑solving skills, with a structured approach to identifying root causes and implementing corrective actions.
• Effective communication and collaboration skills for working with cross‑functional teams and production staff.
• Comfort working hands‑on with production equipment and processes in a manufacturing environment.

Additional Skills & Qualifications

• Experience working with medical device manufacturing processes, including reprocessing of catheters and other medical devices.
• Familiarity with medical device quality systems and documentation practices.
• Exposure to or formal training in Lean Six Sigma or Six Sigma tools and techniques.
• Experience leading or contributing to continuous improvement projects in a high‑compliance environment.
• Ability to manage multiple projects simultaneously and prioritize tasks in a fast‑paced setting.
• Interest in owning projects end‑to‑end, from concept and validation through implementation and continuous improvement.
• Motivation to grow technically and professionally while contributing to the scaling of manufacturing operations.

Work Environment

This is a full‑time, onsite MondayFriday position in a fast‑paced medical manufacturing facility. The role combines office‑based responsibilities, such as documentation and data analysis, with regular time on the production floor working directly with equipment, processes, and manufacturing teams. You will work in a regulated environment that adheres to ISO, FDA 21 CFR Part 820, and GMP standards, with close collaboration across engineering, quality, and operations. The setting offers exposure to advanced manufacturing technologies and provides opportunities to own projects, develop new processes, and contribute to the expansion and scaling of the organization.

Job Type & Location

This is a Permanent position based out of Scottsdale, AZ.

Pay And Benefits

The pay range for this position is $100000.00 - $130000.00/yr.

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.

Competitive benefits package available for full‑time employees. Additional details regarding medical coverage, paid time off, retirement benefits, and other offerings will be provided during the interview process.

Job Type & Location

This is a Permanent position based out of Scottsdale, AZ.

Application Deadline

This position is anticipated to close on Nov 18, 2026.

Workplace Type

This is a fully onsite position in Scottsdale,AZ.

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.