Job Description
Job Description
Description
This role supports and improves manufacturing operations for regulated medical device products, with a focus on process efficiency, product quality, and compliance. The engineer will work cross-functionally with production, quality, and R&D to troubleshoot issues, implement improvements, and support new product introduction.
Must-Have Qualifications
Bachelor’s degree in Engineering or related technical field
5+ years of experience in a regulated manufacturing environment (medical device highly preferred)
Working knowledge of:
FDA QSR
ISO 13485:2016
EU MDR (2017/745)
Hands-on experience with process validation (IQ, OQ, PQ)
Experience with non-conformance investigations, CAPA, and root cause analysis
Strong understanding of statistical process control (SPC) and process improvement
Proficiency with SolidWorks and Microsoft Office (Excel, Word)
Key Responsibilities
Provide engineering support to production and product development teams
Develop and improve manufacturing processes, tooling, and equipment to enhance quality and reduce costs
Troubleshoot and resolve production issues related to processes and equipment
Lead and support validation activities (IQ/OQ/PQ) for new and existing processes
Investigate non-conformances and drive corrective and preventive actions (CAPA)
Maintain and update manufacturing documentation, including specifications and DCRs
Support new product introduction (NPI) and transfer from R&D into production
Partner with Quality to improve inspection methods and ensure compliance
Create and monitor SPC/control charts to drive process consistency
Assist with preventative maintenance planning and equipment support
Train production personnel on new or updated processes
Skills
Manufacturing engineering, Gmp, solidworks, npi, Process improvement, Manufacturing process, IQ, PQ, OQ, FDA, QSR, EU MDR, iso 13485, r&d, Continuous improvement, quality management, document change orders, change orders, preventive maintenance, equipment maintenance, equipment validation, equipment reliability, medical device, opthamology
Top Skills Details
Manufacturing engineering,Gmp,solidworks,npi
Additional Skills & Qualifications
Experience in ophthalmic or optometric devices
Experience supporting batch records and production documentation
Experience in equipment maintenance or manufacturing automation
Strong analytical and problem-solving skills
Ability to operate independently and collaborate cross-functionally
Effective communication and documentation skills
Detail-oriented with strong time management and prioritization ability
Experience Level
Intermediate Level
Job Type & Location
This is a Contract to Hire position based out of Glendora, CA.
Pay and Benefits
The pay range for this position is $40.00 - $60.00/hr.
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 Glendora,CA.
Application Deadline
This position is anticipated to close on Jun 25, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
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 actalentaccommodation@actalentservices.com 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.