Title: Manufacturing Engineer II
Duration: 12 Months
Location: Irvine, CA 92614 (100% Onsite)
Work Schedule: 1st Shift, 5:00 AM - 1:30 PM (standard hours, with limited overtime and adjusted hours as needed); Onboarding hours for initial 4-6 weeks: 8:00 AM - 4:30 PM
Position Summary: 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.
Background & Context:
- This role comes with expectations of self-starters 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.
Key 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.
Qualification & Experience:
- Bachelors Degree ( 16 years) in Engineering or related, or an equivalent combination of education and work experience.
- 2-4 years working experience on similar roles.
- 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.
Key requirements: Bachelor's of Engineering or similar. Medical device engineering experience is a must. Preferred experience in medical device manufacturing.
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Spectraforce Technologies
Jun 10, 2025