Manufacturing Engineering Supervisor

2 weeks ago


Carlsbad, United States Lumos Diagnostics Full time

About Lumos Diagnostics:

Lumos Diagnostics is embarking on an exciting path of growth and innovation, seeking motivated individuals to contribute significantly to our mission. Our workplace culture emphasizes teamwork, ongoing enhancement, and a collective commitment to improving the healthcare sector. If you aspire to be part of a pioneering and supportive environment, Lumos Diagnostics is the ideal place for you.

Position Overview:

The Manufacturing Engineering Supervisor plays a vital role within the Manufacturing Team at Lumos Diagnostics. This position entails overseeing the assembly and kitting workforce daily, collaborating closely with the lead chemistry manufacturing group. The Supervisor will enhance production workflows, manage equipment upkeep, and guarantee the precision of Bill of Materials (BOMs) in a high-energy manufacturing setting. This role is centered on the seamless transition of products from development to large-scale production while upholding superior quality standards and adhering to GMP/ISO 13485 regulations. The perfect candidate will be hands-on, technically adept, and capable of spearheading continuous improvement efforts to refine production processes.

Key Responsibilities:

1. Oversight of Manufacturing and Team Collaboration

  • Enhance production techniques to boost efficiency and product quality.
  • Supervise the daily operations of the assembly and kitting team.
  • Work with the planning team to develop manufacturing schedules.
  • Create work orders and manage material issuance, while providing training and guidance on manufacturing protocols.
  • Meet production targets and quality benchmarks.

2. Equipment Maintenance and Setup:

  • Formulate and execute maintenance strategies for all production machinery, ensuring minimal operational interruptions.
  • Oversee the setup, adjustment, and validation of equipment to fulfill production demands.
  • Lead IQOQPQ (Installation Qualification, Operational Qualification, Performance Qualification) for all operational equipment.

3. Management of Bill of Materials (BOMs):

  • Ensure all materials listed in the BOM are accurately tracked and supplied by the Supply Chain team during production.
  • Collaborate with engineering and supply chain teams to keep BOMs current and reflective of existing manufacturing processes.
  • Maintain the integrity and completeness of BOMs for all products to facilitate efficient production operations.
  • Assist in confirming that BOMs align with the latest product design modifications, ensuring they effectively support the manufacturing workflow.

4. Quality Assurance and Compliance:

  • Guarantee that production processes adhere to GMP/ISO 13485 standards and other applicable regulations.
  • Collaborate with the Quality Assurance (QA) team to resolve non-conformances and implement corrective measures.
  • Develop and report on key performance indicators (KPIs) related to production and equipment performance.

5. Project Management:

  • Lead and coordinate multiple projects, ensuring timely completion within budget and specifications.
  • Engage with stakeholders to communicate project updates and address any issues or scope changes.

6. Continuous Improvement Initiatives:

  • Identify areas for process enhancement within production and engineering sectors.
  • Implement best practices from other facilities or industries to improve manufacturing operations.
  • Design and execute initiatives aimed at boosting overall production efficiency and product quality.

7. Additional Responsibilities as Assigned:

  • Demonstrate flexibility to assist with various manufacturing-related tasks and projects as necessary to support the overarching goals of the Manufacturing department and the organization.

Qualifications:

  • At least 8 years of experience in a manufacturing setting, ideally within a regulated industry.
  • In-depth knowledge of equipment maintenance, production workflows, and BOM management.
  • Familiarity with ERP systems, lean methodologies, and analytical problem-solving.
  • Understanding of GMP/ISO 13485 standards and their application in production processes.
  • Exceptional communication and technical writing abilities.
  • Proven ability to work effectively in a cross-functional team environment and manage competing priorities.
  • Demonstrated supervisory experience with a successful track record of leading teams.
  • Strong understanding of operational and production excellence processes, including change control.
  • Exhibits a proactive attitude, high energy, and a solution-oriented approach to tasks and challenges.
  • Ability to thrive in fast-paced, dynamic environments while maintaining composure and efficiency.
  • Exemplifies meticulous attention to detail, ensuring accuracy and quality in all endeavors.
  • Strong problem-solving skills, with a keen ability to identify issues and implement effective solutions.

Preferred 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.
  • Prior 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 context.

Compensation and Benefits:

In the spirit of transparency, the salary range for this position is $78,000 to $90,000 annually, exclusive of potential bonuses. Final compensation will be determined based on factors such as geographic location, skills, education, and experience. We also value pay equity and consider the internal equity of our current team members as part of any final offer.

Why Lumos Diagnostics?

  • Innovative Environment: Contribute to a team dedicated to developing advanced diagnostic solutions.
  • Collaborative Culture: Engage in a supportive, dynamic, and inclusive workplace where your contributions are recognized.
  • Impactful Work: Play a crucial role in the healthcare industry by ensuring the highest quality standards in our products.

To Apply:

If you are passionate about production engineering and eager to be part of a dynamic team making a difference, we encourage you to submit your resume outlining your qualifications for the Manufacturing Engineering Supervisor role at Lumos Diagnostics.

Lumos Diagnostics is an Equal Opportunity Employer.



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