Manufacturing Engineer

Hologic-posted 10 days ago
Full-time • Mid Level
Onsite • San Diego, CA
5,001-10,000 employees
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Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day. The San Diego Campus is the center of our Diagnostics Solutions Division. With the focus on Molecular Diagnostics, most products produced are utilized onboard innovative and fully automated sample-to-result instrument systems. The consumables required for patient testing are integral to our business. The business growth projections and new product development projects provide unique opportunities to enable our Purpose, Passion, and Promise to empower global health advancements. Our Manufacturing Operations department is looking for an experienced Manufacturing Engineer responsible for providing engineering support in the areas of injection molded consumables, services including evaluation, purchase, installation, and qualification of new manufacturing equipment. This is a fully onsite role based in San Diego, CA.

  • Provide technical guidance and interface with injection molding vendors
  • Provide technical input on consumable parts drawings and mold drawings
  • Manage qualifying and changes in raw materials, vendors and perform investigations for non-conformance events
  • Provides general engineering services and support
  • Manage the design, acquisition, installation and commission of mechanical/electrical equipment, systems and parts to support manufacturing
  • Perform process transfers from Engineering to Manufacturing including processes and equipment training
  • Provides technical engineering support for repairing, troubleshooting and modifying equipment and systems
  • Supports equipment mechanics
  • Create and/or modifies equipment maintenance procedures
  • Manage outside vendor’s with installation, qualification and sustaining support of equipment and processes
  • Writing and reviewing operating procedures, documents and reports
  • Performs equipment, process and product performance testing
  • Provides QS validation input and support for new equipment and process validations
  • Writing and executing Installation, Operation, and Performance Qualification Validations; including writing final reports
  • Reviews and approves calibration datasheets
  • In-depth knowledge of injection molding process for high volume consumable plastics
  • Familiarity with cGMP regulations and guidelines related to plastics in the pharmaceutical or biotechnology industry.
  • Working knowledge of microprocessor controls, utility distribution systems and process engineering
  • Biotech / Medical Device / Pharmaceutical industry experience
  • Thorough knowledge of manufacturing automation systems and best design practice
  • Experience with PLC/SCADA systems used for water system control and monitoring.
  • Experience generating and updating FMEAs
  • Proficient with GD&T and technical drawings
  • Excellent problem-solving, analytical, and troubleshooting skills.
  • Strong technical writing and communication skills.
  • Ability to work independently and as part of a multidisciplinary team.
  • High proficiency with Microsoft Suite
  • High proficiency with statistical analysis techniques
  • Working knowledge of manufacturing automation systems and design practices
  • Working knowledge of cGMP, GAMP, ISO 13485, and FDA 21 CFR, Part 820
  • Identifies problems, solves them, acts decisively, and shows good judgment
  • Plans and organizes work efficiently to manage time wisely. Prioritizes tasks within a dynamic and fast-paced working environment
  • Exhibits a high level of energy and is self-motivated to sustain ambitious work
  • Continuously seeks new knowledge and rapidly assimilates it into the organization
  • BS degree in Chemical Engineering, Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or related Engineering discipline with 6 -8 years of related industry experience
  • Certified Water Technologist (CWT) preferred but not required
  • Lean Manufacturing and/or Six-Sigma Certification preferred but not required
  • Certified Quality Engineering Certification preferred but not required
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