Production Engineering Supervisor

4 weeks ago

Carlsbad, United States Lumos Diagnostics Full time

About Lumos Diagnostics:


At Lumos Diagnostics, we are on an exciting journey of expansion and innovation, and we are looking for dynamic, self-motivated individuals to join our team and make a significant impact. Our culture is built on collaboration, continuous improvement, and a shared passion for making a difference in the healthcare industry. If you are looking for an environment where you can contribute to cutting-edge advancements and be part of a forward-thinking, supportive team, Lumos Diagnostics is the place for you.


Position Summary:


The Production Engineering Supervisor is a key member of the Manufacturing Team at Lumos Diagnostics. This role is responsible for daily oversight of the assembly and kitting team, working in collaboration with the lead chemistry manufacturing team. The Supervisor will oversee and optimize production processes, manage equipment maintenance, and ensure the accuracy of Bill of Materials (BOMs) within a fast-paced manufacturing environment. This role focuses on the efficient transfer of products from development to full-scale production, maintaining the highest standards of quality and compliance with GMP/ISO 13485 standards. The ideal candidate will be hands-on, technically proficient, and capable of driving continuous improvement initiatives to optimize production operations.


Key Responsibilities:


1. Manufacturing Oversight and Collaboration

  • Support the optimization of production methods to enhance efficiency and product quality.
  • Daily oversight of the manufacturing assembly and kitting team
  • Collaboration with the planning team to prepare manufacturing schedules
  • Creation of work orders and issuance of materials, as well as providing training and mentorship on manufacturing processes
  • Meeting production forecasts
  • Achieving quality targets


2. Equipment Maintenance and Setup:

  • Develop and implement maintenance plans for all production equipment, ensuring minimal downtime.
  • Perform the setup, adjustment, and verification of equipment to meet production requirements.
  • Lead IQOQPQ (Installation Qualification, Operational Qualification, Performance Qualification) on all Operations equipment.


3. Bill of Materials (BOMs) Management:

  • Ensure that all materials listed in the Bill of Materials (BOM) are accurately accounted for and provided by the Supply Chain team as part of the production process.
  • Collaborate with engineering and supply chain teams to keep BOMs updated and reflective of current manufacturing processes.
  • Maintain the accuracy and completeness of BOMs for all products to support efficient production operations.
  • Assist in verifying that BOMs are aligned with the latest product design changes, ensuring they support the manufacturing process effectively.


4. Quality and Compliance:

  • Ensure production processes comply with GMP/ISO 13485 standards and other relevant regulations.
  • Work closely with the Quality Assurance (QA) team to address non-conformances and implement corrective actions.
  • Develop and report on key performance indicators (KPIs) related to production and equipment performance.


5. Project Management:

  • Lead and manage multiple projects, ensuring timely completion within budget and to specifications.
  • Interface with stakeholders to communicate project progress and address any issues or changes in scope.


6. Continuous Improvement:

  • Identify opportunities for process improvement within the production and engineering areas.
  • Implement best practices from other sites or industries to enhance manufacturing operations.
  • Develop and execute initiatives aimed at improving overall production efficiency and product quality.

7. Other Duties as Assigned by Management:

  • Flexibility to assist with various Manufacturing-related tasks and projects as needed to support the overall objectives of the Manufacturing department and the organization.


Qualifications:


  • Minimum of 8 years of experience in a manufacturing environment, preferably in a regulated industry.
  • Strong knowledge of equipment maintenance, production processes, and BOM management.
  • Experience with ERP systems, lean principles, and analytical problem-solving.
  • Knowledge of GMP/ISO 13485 standards and their application in production processes
  • Excellent communication and technical writing skills.
  • Ability to work effectively in a cross-functional team environment and manage multiple priorities.
  • Proven supervisory experience with a track record of leading teams effectively.
  • Strong knowledge of operational and production excellence processes, including change control.
  • Demonstrates a can-do attitude, high energy, and a proactive approach to tasks and challenges.
  • Capable of thriving in fast-paced, dynamic environments while maintaining composure and efficiency.
  • Exhibits exceptional attention to detail, ensuring accuracy and quality in all work.
  • Strong problem-solving abilities, with a keen ability to identify issues and implement thoughtful, effective solutions.


Preferred Work Experience:


  • Familiarity with medical devices and their manufacturing processes
  • Experience as a machine operator, particularly with equipment such as Real to Real and Bio Dot machines
  • Previous experience in engineering or maintenance roles within a highly regulated environment, such as biotech or pharmaceuticals
  • Hands-on experience with equipment validation and calibration in a manufacturing setting


Compensation and Benefits:


In the spirit of pay transparency, we are excited to share that the pay range for this position is $78,000 to $90,000 annually, exclusive of potential bonuses. Your final base compensation will be determined based on factors such as geographic location, skills, education, and experience. In addition to those factors, we believe in the importance of pay equity and consider the internal equity of our current team members as part of any final offer. Please note that relocation assistance is not offered for this position.


Why Join Lumos Diagnostics?


  •  Innovative Environment: Be part of a team dedicated to developing cutting-edge diagnostic solutions.
  • Collaborative Culture: Work in a supportive, dynamic, and inclusive environment where your contributions are valued.
  •  Impactful Work: Make a difference in the healthcare industry by ensuring the highest quality standards in our products.


To Apply:


If you are passionate about production engineering and excited to join a dynamic team making a difference, we encourage you to apply. Submit your resume outlining your qualifications for the Production Engineering Supervisor role at Lumos Diagnostics.


Lumos Diagnostics is an Equal Opportunity Employer.

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