Senior Manufacturing Engineer

Job Title: Senior Manufacturing Engineer Job Description The Senior Manufacturing Engineer plays a critical role in developing, validating, and optimizing manufacturing processes for medical devices in a regulated environment. This position drives 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. This is an opportunity to own projects, develop new processes, improve manufacturing operations, and help shape how the organization scales, while continuing to grow technically and professionally. Responsibilities

- Lead the development, validation, and optimization of manufacturing processes for medical devices, ensuring they are robust, efficient, and scalable.
- Plan, execute, and document IQ/OQ/PQ process validations in accordance with ISO, FDA 21 CFR Part 820, and GMP requirements.
- Support new product introductions and new product implementation by translating design requirements into stable, compliant manufacturing processes.
- Drive continuous improvement initiatives using Lean Six Sigma and other methodologies to enhance product quality, reduce waste, and improve throughput.
- Lead and participate in CAPA activities, including problem identification, investigation, and implementation of effective corrective and preventive actions.
- Perform root cause analysis on manufacturing issues, nonconformances, and process deviations, and implement sustainable solutions.
- Apply statistical process control (SPC) and other data-driven tools to monitor process performance and maintain process capability.
- Collaborate closely with production, quality, engineering, and other cross-functional teams to support day-to-day manufacturing operations and resolve technical issues.
- Ensure all manufacturing processes and documentation comply with ISO standards, FDA 21 CFR Part 820 regulations, and GMP practices.
- Contribute to the creation and maintenance of technical documentation, including validation protocols, reports, work instructions, and process specifications.
- Identify opportunities to improve equipment utilization, workflow, and layout to support operational efficiency and expansion.
- Provide technical guidance and support to manufacturing teams on process requirements, best practices, and continuous improvement methods.

Essential Skills

- Minimum 5 years of hands-on experience executing IQ/OQ/PQ process validations in a manufacturing environment.
- At least 5 years of experience working with and applying ISO standards, FDA 21 CFR Part 820, and GMP requirements.
- Minimum 5 years of proven experience with CAPA, root cause analysis, SPC, and continuous improvement initiatives.
- Strong background in manufacturing engineering within the medical device sector.
- Demonstrated expertise in process validation and qualification, including IQ, OQ, and PQ.
- Solid understanding of GMP principles and quality system requirements for regulated manufacturing.
- Experience supporting new product introductions and new product implementation in a production environment.
- Proficiency in root cause analysis techniques and problem-solving methodologies.
- Ability to use statistical tools such as SPC to analyze process data and drive decisions.
- Hands-on, practical approach to working with production equipment, processes, and manufacturing teams.

Additional Skills & Qualifications

- Experience working in a medical device manufacturing or reprocessing environment, including catheters and other device classes.
- Familiarity with Lean Six Sigma and Six Sigma methodologies for process improvement.
- background in continuous improvement projects aimed at optimizing quality, cost, and delivery.
- Comfort working cross-functionally with engineering, quality, and operations teams.
- Strong communication skills to clearly document validation activities, procedures, and process changes.
- Ability to manage multiple projects and priorities in a fast-paced environment.
- Interest in contributing to an organization in an exciting stage of expansion and scaling.

Work Environment This is an onsite, MondayFriday role in a fast-paced medical manufacturing facility. The position 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 operate in a regulated environment that adheres to ISO standards, FDA 21 CFR Part 820, and GMP practices, with close collaboration across engineering, quality, and operations. The setting offers exposure to advanced manufacturing technologies and provides opportunities to lead projects and drive operational improvements as the organization expands.
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. Aetna medical and prescription drug coverage, Delta Dental, Delta Vision, and Reliance Standard life/disability plans
Job Type & Location
This is a Permanent position based out of Scottsdale, AZ.
Application Deadline
This position is anticipated to close on Nov 11, 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 [email protected] 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.