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Manufacturing Engineering Lead

2 months ago

Carlsbad, United States Lumos Diagnostics Full time

About Lumos Diagnostics:

Lumos Diagnostics is on a transformative 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 healthcare solutions. If you aspire to be part of a progressive and supportive environment, Lumos Diagnostics welcomes you.

Position Overview:

The Manufacturing Engineering Supervisor plays a crucial role within the Manufacturing Team at Lumos Diagnostics. This position entails overseeing the assembly and kitting workforce, collaborating closely with the lead chemistry manufacturing team. The Supervisor is tasked with refining production workflows, managing equipment upkeep, and ensuring the precision of Bill of Materials (BOMs) in a high-energy manufacturing setting. This role is pivotal in facilitating the seamless transition of products from development to large-scale production while upholding the highest quality standards and adhering to GMP/ISO 13485 regulations. The ideal candidate will possess hands-on experience, technical expertise, and a drive for continuous operational improvements.

Key Responsibilities:

1. Oversight of Manufacturing Operations

  • Enhance production techniques to boost efficiency and product quality.
  • Supervise the daily activities of the assembly and kitting teams.
  • Coordinate with the planning department to establish manufacturing timelines.
  • Generate work orders and allocate materials, providing training and guidance on manufacturing protocols.
  • Meet production goals and quality benchmarks.

2. Equipment Maintenance and Configuration:

  • Create and execute maintenance schedules for all production machinery to minimize downtime.
  • Oversee the setup, calibration, and validation of equipment to fulfill production demands.
  • Lead IQOQPQ (Installation Qualification, Operational Qualification, Performance Qualification) for all operational machinery.

3. Management of Bill of Materials (BOMs):

  • Ensure all materials 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 manufacturing processes.
  • Maintain the accuracy and completeness of BOMs to support efficient production workflows.
  • Assist in confirming that BOMs align with the latest product design modifications, ensuring effective support for manufacturing.

4. Quality Assurance and Compliance:

  • Guarantee that production processes adhere to GMP/ISO 13485 standards and relevant regulations.
  • Work in conjunction with the Quality Assurance (QA) team to resolve non-conformities and implement corrective measures.
  • Develop and report on key performance indicators (KPIs) related to production and equipment efficiency.

5. Project Leadership:

  • Manage multiple projects, ensuring they are completed on time, within budget, and to specifications.
  • Engage with stakeholders to communicate project status and address any challenges or changes in scope.

6. Continuous Improvement Initiatives:

  • Identify and implement process enhancement opportunities within production and engineering.
  • Adopt best practices from other sites or industries to improve manufacturing operations.
  • Design and execute initiatives aimed at boosting overall production efficiency and product quality.

7. Additional Responsibilities:

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

Qualifications:

  • At least 8 years of experience in a manufacturing setting, preferably within a regulated industry.
  • Strong understanding of equipment maintenance, production workflows, and BOM management.
  • Experience with ERP systems, lean methodologies, and analytical problem-solving.
  • Familiarity with GMP/ISO 13485 standards and their application in production.
  • Excellent communication and technical writing abilities.
  • Ability to thrive in a cross-functional team environment and manage multiple priorities.
  • Proven leadership experience with a history of effectively guiding teams.
  • Strong knowledge of operational excellence processes, including change management.
  • Demonstrates a proactive approach and high energy in tackling tasks and challenges.
  • Capable of maintaining composure and efficiency in fast-paced, dynamic environments.
  • Exhibits exceptional attention to detail, ensuring accuracy and quality in all tasks.
  • Strong problem-solving skills, with an aptitude for identifying issues and implementing effective solutions.

Preferred Experience:

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

Compensation and Benefits:

The salary range for this position is $78,000 to $90,000 annually, excluding potential bonuses. Final compensation will be determined based on geographic location, skills, education, and experience. We prioritize pay equity and consider the internal equity of our current team members in final offers.

Why Lumos Diagnostics?

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

To Apply:

If you are passionate about production engineering and eager to contribute to a dynamic team, 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.