Manufacturing Engineer - Onsite
Collabera Inc.
Irvine, CA, USA
USD 50-57 / hour
Posted on Jun 12, 2025
Manufacturing Engineer - Onsite
Contract: Irvine, California, US
Salary Range: 50.00 - 57.00 | Per Hour
Job Code: 362830
End Date: 2025-07-11
Days Left: 28 days, 9 hours left
Position Details:
Industry: Medical Devices
Job Title: Manufacturing Engineer - Onsite
Location: Irvine, CA 92612
Duration: 12+ months [+ Possibilities of extension]
Pay Range: $50-$57/hr
Description:
- The manufacturing engineer will develop and implement optimal, cost-effective manufacturing processes and methods in accordance with product specifications and quality standards; recommend and implement improvements to existing production processes, methods and controls; be responsible for the activities related to procurement, installation, and validation of production line equipment as well as the lifecycle management of equipment; provide line support and training to operations staff; perform root cause analysis on product, process, equipment, and operational failures, and implement corrections/corrective actions as required.
- This role comes with expectations of self-starers with experience in medical device environment. Individual must anticipate and identify key issues and make recommendations for resolution while remaining compliant to Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and other requirements. Interaction with peers, manufacturing operations, and light mentorship from management is expected.
- This position primarily provides 1st shift support. Planned hours are 5:00 AM – 1:30 PM, with opportunity for limited overtime, and altered hours when required by the business. Onboarding hours for the initial month will be roughly 8:00 AM – 4:30 PM. This position is fully onsite.
Responsibilities:
- Daily support to the manufacturing activities in order to meet established goals for safety, quality, cost and production.
- Maintains systems that support the monitoring of key performance indicators such as yield, nonconforming material or lead time. If indicators show an adverse trend, works with the functional team to plan and implement appropriate changes.
- Requires work in controlled access environment and adherence to medical device manufacturing standards and regulations.
- Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
- Uses basic statistic tools.
- Performs installation/validation activities for new or existent production lines, meeting regulatory requirements. That includes equipment, process, product and test method validations.
- Identifies, selects, and purchases equipment/fixtures according to production requirements, due to obsolescence, redundancy or line capacity expansion.
- Has direct relation with vendors to define equipment suitability.
- Keeps equipment operational by coordinating calibration, maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service when needed.
- Has knowledge and expertise on product requirements and specifications.
- Understands potential risks related to product malfunctions.
- Assures that production lines output meet the specifications of the product.
- Has clear criteria of conforming/ non conforming product and the test methods used for verifying conformance.
- Maintains manufacturing systems such as SAP routers and BOM's current.
- Maintains MP's current and compliant to regulations. Ensures practices at the manufacturing floor adhere to them.
- Supports DL's & IDL's training process.
- Leads or supports local cross functional team activities.
- Participates in the identification and investigation of Non-conforming products. Uses Root cause problem solving techniques to identify and eliminate causes, implements controls and define preventive activities.
- Leads or supports continuous improvement projects for any of the main key areas: safety, quality and production.
- Must be independent and proactive in identifying opportunities for improvement.
- Must be flexible and reactive in an environment of constantly changing priorities.
- Other responsibilities may be assigned as required.
Qualifications:
- Bachelor's degree in Engineering or related required. 2-4 years exp required.
- Demonstrated independence while working as an engineer in a regulated medical device manufacturing environment is recommended.
- Statistical techniques knowledge (DOE, SPC) is required.
- Computer software knowledge (Microsoft Word, Excel, Power Point).
- Fluency of English (written and speaking) required.
- Experience in medical device manufacturing, process improvement and line support, root cause problem solving methodologies (DMAIC or equivalent), fixture development and design is desired.
- Manufacturing operations experience is a benefit.
- Knowledge of FDA, GMP and ISO guidelines is desired.
Job Requirement
- Manufacturing Engineer
- Manufacturing Specialist
- Process Engineer
- DOE
- SPC
- DMAIC
- Manufacturing operations
- Production
- Production Supervisor
- GMP
- Medical Device
- IVDD
- Root Cause Analysis
- CAPA
- Lean Manufacturing
Reach Out to a Recruiter
- Recruiter
- Phone
- Niharika Shrivastava
- niharika.shrivastava@collabera.com