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 proactive and motivated individuals to contribute significantly to our mission. Our organizational culture emphasizes teamwork, ongoing development, and a collective commitment to enhancing the healthcare sector. If you aspire to be part of a progressive and supportive environment where you can influence groundbreaking advancements, Lumos Diagnostics is the ideal workplace for you.

Position Overview:

The Manufacturing 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 team. The Supervisor will focus on optimizing production workflows, managing equipment upkeep, and ensuring the precision of Bill of Materials (BOMs) in a dynamic manufacturing setting. This role is dedicated to 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 perfect candidate will be hands-on, technically adept, and capable of spearheading continuous improvement initiatives to enhance production efficiency.

Key Responsibilities:

1. Oversight of Manufacturing Operations

  • Enhance production methodologies to improve efficiency and product quality.
  • Provide daily supervision of the assembly and kitting teams.
  • Collaborate with the planning department to establish manufacturing schedules.
  • Generate work orders and manage material issuance, while also offering training and mentorship on manufacturing protocols.
  • Meet production targets and quality benchmarks.

2. Equipment Maintenance and Configuration:

  • Formulate and execute maintenance strategies for all production machinery to minimize downtime.
  • 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.
  • Work alongside engineering and supply chain teams to keep BOMs current and reflective of existing manufacturing practices.
  • Maintain the accuracy and completeness of BOMs for all products to facilitate efficient production.
  • Assist in verifying that BOMs align with the latest product design modifications, ensuring they effectively support the manufacturing process.

4. Quality Assurance and Compliance:

  • Guarantee that production processes adhere to GMP/ISO 13485 standards and other applicable regulations.
  • Collaborate closely 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 Leadership:

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

6. Continuous Improvement Initiatives:

  • Identify opportunities for process enhancements within production and engineering domains.
  • Implement best practices from other facilities or industries to improve manufacturing operations.
  • Develop and execute strategies aimed at boosting overall production efficiency and product quality.

7. Additional Responsibilities as Assigned:

  • Exhibit flexibility to assist 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.
  • 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 environments.
  • Excellent communication and technical writing abilities.
  • Ability to work effectively in a cross-functional team and manage multiple priorities.
  • Proven supervisory experience with a successful track record of leading teams.
  • Strong knowledge of operational excellence processes, including change control.
  • Demonstrates a proactive attitude, high energy, and a positive approach to 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 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 the spirit of transparency, the pay 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 prioritize pay equity and consider the internal equity of our current team members in any final offer.

Why Choose 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 eager to contribute to 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.

  • 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...

  • Manufacturing Engineering Lead

    2 weeks 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...

  • Manufacturing Engineer

    4 weeks ago

    Carlsbad, United States Indotronix Avani Group Full time

    Job Title: Manufacturing Process EngineerLocation: Carlsbad, CA 92008Duration: 12 MonthsShift: Mon-Fri 8am-5pmPay Rate: $37.00How will you make an impact?The Manufacturing Process Engineer is a critical component for maintaining our Quality Management System and driving improvements through projects. This individual will have the ability drive resolutions to...

  • Manufacturing Engineer

    4 weeks ago

    Carlsbad, United States Indotronix Avani Group Full time

    Job Title: Manufacturing Process EngineerLocation: Carlsbad, CA 92008Duration: 12 MonthsShift: Mon-Fri 8am-5pmPay Rate: $37.00How will you make an impact?The Manufacturing Process Engineer is a critical component for maintaining our Quality Management System and driving improvements through projects. This individual will have the ability drive resolutions to...

  • Manufacturing Engineer

    2 months ago

    Carlsbad, United States Spectrum Assembly, Inc. Full time

    Job DescriptionJob DescriptionSAI, a growing electronic contract manufacturer located in Carlsbad is seeking an experienced well rounded manufacturing Engineer. This opportunity is for the pm shift and will assist in all areas of production with technical knowledge. The Engineer will be able to take a project from the conception stage through to completion....

  • Manufacturing Process Engineer

    4 weeks ago

    Carlsbad, United States TekWissen ® Full time

    Position: Manufacturing Process EngineerLocation: Carlsbad, CA, 92008Duration: 12 MonthsJob Type: ContractWork Type: OnsiteShift: Monday- Friday 8.00AM-5.00PMPay Rate: $30 to $36/hrOverview TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients specializing...

  • Manufacturing Process Engineer

    4 weeks ago

    Carlsbad, United States TekWissen LLC Full time

    Job DescriptionJob DescriptionOverview TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential...

  • 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...

  • Manufacturing Process Engineer

    2 weeks ago

    Carlsbad, United States AdvantEdge Full time

    Position: Manufacturing Process Engineer Location: Carlsbad, CA, 92008Duration: 12 MonthsJob Type: ContractWork Type: OnsiteShift: Monday- Friday 8.00AM-5.00PMPay Rate: $37 to $37/hrHow will you make an impact? The Manufacturing Process Engineer is a critical component for maintaining our Quality Management System and driving improvements through...

  • Manufacturing Process Engineer

    2 weeks ago

    Carlsbad, California, United States Niktor LLC Full time

    Job OverviewPosition Title: Manufacturing Process EngineerEmployment Duration: 12 MonthsWork Schedule: 40 hours per week, 1st shift with flexible start time after training.Pay Rate: Competitive hourly rateCompany Mission:At Niktor LLC, our mission is to empower our clients to create a healthier, cleaner, and safer world. We support our customers in various...

  • Manufacturing Process Engineer

    2 weeks ago

    Carlsbad, California, United States Niktor LLC Full time

    Job OverviewPosition Title: Manufacturing Process EngineerContract Duration: 12 MonthsWork Schedule: Full-time, 1st shift, flexible start time after training.Compensation: Competitive hourly rateRole SummaryThe Manufacturing Process Engineer plays a vital role in upholding our Quality Management System while spearheading enhancements through various...

  • Manufacturing Engineering Supervisor

    2 weeks ago

    Carlsbad, United States Lumos Diagnostics Full time

    About Lumos Diagnostics:Lumos Diagnostics is embarking on a thrilling path of growth and innovation, seeking motivated individuals who can make a substantial difference. Our organizational culture emphasizes teamwork, ongoing enhancement, and a collective commitment to transforming the healthcare sector. If you desire a setting where you can engage in...

  • Manufacturing Engineer

    4 weeks ago

    Carlsbad, United States Indotronix Avani Group Full time

    Title: Manufacturing Process EngineerLocation: Carlsbad, CADuration: 12 MonthsPay Rate: $37/hr.How will you make an impact?The Manufacturing Process Engineer is a critical component for maintaining our Quality Management System and driving improvements through projects.What will you do?Optimize existing products and processes to improve efficiency and...

  • Manufacturing Engineer

    4 weeks ago

    Carlsbad, United States Indotronix Avani Group Full time

    Title: Manufacturing Process EngineerLocation: Carlsbad, CADuration: 12 MonthsPay Rate: $37/hr.How will you make an impact?The Manufacturing Process Engineer is a critical component for maintaining our Quality Management System and driving improvements through projects.What will you do?Optimize existing products and processes to improve efficiency and...

  • Manufacturing Process Engineer

    4 weeks ago

    Carlsbad, United States Cogent Infotech Corporation Full time $35 - $37

    Job DescriptionJob DescriptionShift/Schedule -  Mon-Fri 8am-5pmJob Description -Job Title: Manufacturing Process EngineerIt is 40 hrs/week, 1st shift. Actual start time is a bit flexible within the 1st shift once trained.Mon-Fri 8am-5pmOur Mission is to enable our customers to make the world healthier, cleaner and safer.Whether our customers are...

  • Manufacturing Process Engineer

    4 weeks ago

    Carlsbad, United States Niktor Full time

    Job Title: Manufacturing Process EngineerDuration: 12 MonthsLocation: Carlsbad, CA, 92008 Hours: It is 40 hrs/week, 1st shift. Actual start time is a bit flexible within the 1st shift once trained.Mon-Fri 8am-5pm Pay Rate: $37.00 - Hourly Job Description:Yes, this is onsite in CBD. Our Mission is to enable our customers to make the world healthier, cleaner...

  • Manufacturing Process Engineer

    4 weeks ago

    Carlsbad, United States Niktor Full time

    Job Title: Manufacturing Process EngineerDuration: 12 MonthsLocation: Carlsbad, CA, 92008 Hours: It is 40 hrs/week, 1st shift. Actual start time is a bit flexible within the 1st shift once trained.Mon-Fri 8am-5pm Pay Rate: $37.00 - Hourly Job Description:Yes, this is onsite in CBD. Our Mission is to enable our customers to make the world healthier, cleaner...

  • Lean Manufacturing Engineer

    3 weeks ago

    Carlsbad, United States QuidelOrtho Full time

    The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with...

  • Lean Manufacturing Engineer

    3 weeks ago

    Carlsbad, United States QuidelOrtho Full time

    The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with...

  • Manufacturing Process Improvement Engineer

    2 weeks ago

    Carlsbad, California, United States Niktor LLC Full time

    Job OverviewPosition Title: Manufacturing Process Improvement EngineerContract Duration: 12 MonthsWork Schedule: Full-time, 1st shift with flexible start time post-training.Compensation: Competitive hourly rateCompany Mission:At Niktor LLC, our goal is to empower our clients to enhance health, safety, and environmental standards. We support various sectors,...