Sr. Manufacturing Engineer NPI Medical Device

Job Title: Senior Manufacturing Engineer NPI Medical Device Job Description
This Senior Manufacturing Engineer role focuses on supporting validation and commercialization activities within a consumables manufacturing environment for medical devices. You will serve as the technical process owner for new and existing manufacturing processes, ensuring equipment readiness, capacity expansion, process optimization, and continuous improvement. You will collaborate closely with operations, quality, R&D, and external partners to enhance manufacturing capability, improve efficiency, and ensure consistent product quality in a regulated environment.
Responsibilities
- Lead manufacturing process validation activities, including the development and execution of IQ, OQ, and PQ protocols.
- Develop, validate, implement, and optimize manufacturing processes for new and existing medical device products.
- Design and improve manufacturing procedures, production layouts, and semi-automated equipment processes to enhance efficiency and quality.
- Develop, maintain, and update manufacturing specifications, work instructions, and engineering documentation.
- Evaluate equipment performance, identify issues, and implement corrective actions to improve equipment reliability and product quality.
- Support equipment qualification activities and drive process control initiatives, including the adoption of advanced manufacturing technologies.
- Serve as a technical lead for manufacturing and quality investigations, providing guidance and direction to cross-functional teams.
- Conduct root cause analysis using tools such as 5 Whys, Fishbone Analysis, and statistical methods to resolve process and quality issues.
- Drive continuous improvement initiatives focused on yield improvement, scrap reduction, throughput optimization, and labor efficiency.
- Collaborate with suppliers and internal teams to improve equipment capability, process robustness, and overall manufacturing performance.
- Support commercial production ramp-up activities, including identifying and eliminating manufacturing bottlenecks.
- Ensure compliance with FDA Quality System Regulations, applicable ISO requirements, and internal quality procedures in all manufacturing activities.
- Prepare and manage technical documentation, including validation reports, change control records, and process documentation to support audits and regulatory requirements.
- Utilize data-driven approaches and statistical tools to monitor process performance, identify trends, and implement sustainable improvements.
Essential Skills
- Bachelor's degree in Engineering or a related technical discipline.
- 4+ years of manufacturing engineering experience; an advanced degree may be considered with 2+ years of relevant experience.
- Experience supporting medical device manufacturing operations, particularly within a regulated environment.
- Strong knowledge of process validation and equipment qualification, including IQ, OQ, and PQ activities.
- Hands-on experience with manufacturing engineering in a consumables or similar high-volume production environment.
- Proficiency in root cause analysis and problem-solving tools such as 5 Whys and Fishbone Analysis.
- Experience with continuous improvement methodologies focused on yield improvement, scrap reduction, and throughput optimization.
- Knowledge of process control and process improvement methodologies in a manufacturing setting.
- Experience working within FDA regulated manufacturing environments and familiarity with FDA Quality System Regulations.
- Experience with ISO-based quality systems and associated requirements.
- Ability to lead technical investigations and drive cross-functional continuous improvement initiatives.
- Experience with statistical analysis and process control methodologies, including the use of statistical tools.
- Ability to travel up to 40% as needed to support manufacturing activities, supplier engagement, and cross-site collaboration.
Additional Skills & Qualifications
- Experience with statistical analysis software such as Minitab for data analysis and process optimization.
- Familiarity with SAP and MES systems to support production planning, execution, and data tracking.
- Proficiency with design and drafting tools such as AutoCAD and/or SolidWorks for layouts and equipment-related documentation.
- Experience with technical documentation and change control systems within a regulated environment.
- Background in lean manufacturing principles and continuous improvement methodologies.
- Experience with CAPA processes and structured problem-solving in a medical device or similar regulated industry.
- Exposure to automation and advanced manufacturing technologies in a production environment.
- Experience supporting commercialization activities and production ramp-up for new product introductions.
- Strong communication skills to collaborate effectively with operations, quality, R&D, suppliers, and other stakeholders.
Work Environment
The role is based in a medical device manufacturing facility featuring newly established manufacturing lines dedicated to new product introduction (NPI). The environment combines hands-on work on the production floor with office-based tasks performed in cubicle workspaces. You will work closely with cross-functional teams in a structured, regulated setting that emphasizes quality, process discipline, and continuous improvement. The facility leverages technologies such as MES, SAP, statistical analysis tools, and design software to support efficient and compliant operations.
Job Type & Location
This is a Contract to Hire position based out of Northridge, CA.
Pay and Benefits
The pay range for this position is $80.00 - $80.00/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)
Workplace Type
This is a fully onsite position in Northridge,CA.
Application Deadline
This position is anticipated to close on Oct 8, 2026. 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.