Manufacturing Engineering Lead

2 weeks ago

Carlsbad, United States Lumos Diagnostics Full time

About Lumos Diagnostics:

Lumos Diagnostics is embarking on an exciting phase of growth and innovation, seeking motivated and proactive individuals to contribute significantly to our mission. Our organizational culture emphasizes teamwork, ongoing enhancement, and a collective commitment to transforming the healthcare landscape. If you aspire to be part of a progressive and supportive environment that fosters cutting-edge advancements, Lumos Diagnostics is the ideal workplace for you.

Position Overview:

The Production Engineering Supervisor plays a crucial role within the Manufacturing Team at Lumos Diagnostics. This position entails overseeing the daily operations of the assembly and kitting teams, collaborating closely with the lead chemistry manufacturing group. The Supervisor will be responsible for refining production workflows, managing equipment upkeep, and ensuring 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 stages to large-scale production, upholding the utmost quality standards and adherence to GMP/ISO 13485 regulations. The ideal candidate will possess hands-on experience, technical expertise, and a proven ability to spearhead continuous improvement initiatives to enhance production efficiency.

Key Responsibilities:

1. Oversight of Manufacturing Operations

  • Enhance production techniques to boost efficiency and product quality.
  • Supervise the assembly and kitting teams on a daily basis.
  • Coordinate with the planning team to establish manufacturing timelines.
  • Generate work orders and manage material distribution, while providing training and guidance on manufacturing protocols.
  • Meet production goals and quality benchmarks.

2. Equipment Maintenance and Configuration:

  • Formulate and execute maintenance strategies for all production machinery, ensuring minimal operational interruptions.
  • Conduct setup, adjustments, and verification of equipment to align with production demands.
  • Lead IQOQPQ (Installation Qualification, Operational Qualification, Performance Qualification) processes for all operational equipment.

3. Management of Bill of Materials (BOMs):

  • Guarantee that 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 ensure BOMs are current and reflective of ongoing manufacturing practices.
  • Maintain the accuracy and completeness of BOMs for all products to facilitate efficient production workflows.
  • Assist in confirming that BOMs align with the latest product design modifications, ensuring effective support for the manufacturing process.

4. Quality Assurance and Compliance:

  • Ensure that production processes adhere to GMP/ISO 13485 standards and other pertinent regulations.
  • Work in conjunction 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 efficiency.

5. Project Management:

  • Lead and oversee multiple projects, ensuring timely completion within budgetary constraints and specifications.
  • Engage with stakeholders to communicate project developments and address any issues or modifications in scope.

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 in assisting with various manufacturing-related tasks and projects as necessary to support the overall goals of the Manufacturing department and the organization.

Qualifications:

  • At least 8 years of experience in a manufacturing setting, preferably within a regulated industry.
  • In-depth knowledge 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 settings.
  • Exceptional communication and technical writing skills.
  • Ability to collaborate effectively in a cross-functional team environment and manage multiple priorities.
  • Demonstrated supervisory experience with a successful track record of leading teams.
  • Strong understanding of operational and production excellence processes, including change management.
  • Exhibits a proactive attitude, high energy, and a solution-oriented approach to challenges.
  • Capable of thriving in fast-paced, dynamic environments while maintaining composure and efficiency.
  • Exhibits meticulous attention to detail, ensuring accuracy and quality in all tasks.
  • Strong problem-solving skills, with a keen ability to identify issues and implement 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:

In alignment with our commitment to pay transparency, we are pleased to disclose that the salary range for this position is $78,000 to $90,000 annually, exclusive of potential bonuses. The final base compensation will be determined based on factors such as geographic location, skills, education, and experience. Additionally, we prioritize pay equity and consider the internal equity of our current team members as part of any final offer.

Why Consider Lumos Diagnostics?

  • Innovative Atmosphere: Be part of a team dedicated to pioneering advanced diagnostic solutions.
  • Collaborative Environment: Work in a supportive, dynamic, and inclusive setting where your contributions are recognized.
  • Meaningful Impact: Contribute to the healthcare sector by ensuring the highest quality standards in our products.

To Apply:

If you are enthusiastic about production engineering and eager to join a dynamic team making a significant impact, we encourage you to 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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