Senior Manufacturing Engineer

Job Title:
Manufacturing Engineer 5

Location: 10210 Genetic Center Drive, San Diego CA

Duration: 12 months

Shift: 1st Shift

Pay Rate: $80-$90/hr on w2 with Select Source International.

Hologic is one of the world's most innovative medical technology companies and a global champion of women's health. We advance diagnostic, detection, and surgical solutions that respond to an increasingly complex and demanding global healthcare environment. What powers our growth is also what differentiates us: the exceptional, clinically proven ability of our products to detect, diagnose, and treat illnesses and other health conditions earlier and better.

Our commitment to better outcomes for patients, healthcare professionals, and health systems creates high expectations, which we fulfill by relentlessly focusing on the delivery of leading-edge technology that can change the trajectory of diagnoses, treatments, and lives. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.

The San Diego Campus is the center of our Diagnostics Solutions Division. With the focus on Molecular Diagnostics, most products produced from the San Diego site 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.

Hologic is seeking a Manufacturing Engineer responsible for providing engineering support services including automation development, evaluation, purchase, installation, and qualification of new manufacturing equipment.

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• Expertise in vitro diagnostic (IVD) products, cGMP FDA regulatory compliance, and industry guidance initiatives such as MDDAP
• Independently lead multiple custom automation system or new consumable injection molding projects simultaneously
• Independently lead engineering functions such as:
  Design Reviews, Measurement Systems Analysis, Design of Experiments, feasibility studies, process development, acceptance testing, and risk management
• Author documents to develop effective design and control plans
• Establish validation requirements and develop IQ/OQ/PQ documents at suppliers for automation systems and/or injection molds with associated auxiliary equipment that may include leak testers, robots, separation systems, etc.
• Analyze advanced statistics to confirm or reject hypothesis
• Analyze test results, provide recommendations, and author summary reports
• Independently lead the creation of RFQ/URS documentation for injection molds and/or consumables automation systems
• Gather requirements from key stakeholders to author project charters detailing the business need, deliverables, scope, capital and expense scenarios, resource requirements, implementation plan, and risk mitigation proposals
• Continuously improve internal and external supplier processes to reduce the time to market, enhance product quality, and decrease costs
• Develop and/or implement continuous improvement ideas and participate in the strategic Operations plans
• Lead the design transfer process as a core team representative from R&D to Operations, which may include automation, consumables, labeling, assembly, and supplier methods
• Manufacturing team lead for a newly acquired site or new supplier to gain process knowledge, which would support the transfer of consumables manufacturing

• Lead complex cross-functional investigations
• Lead root cause analysis meetings and recommend corrective actions for non-conforming events or manufacturing concerns utilizing risk-based approach methods
• Lead others in ideation activities such as cause-and-effect analysis, process variables mapping, and pFMEAs
• Actively manage asset maintenance with suppliers and monitor performance trends
• Generate innovative possibilities, perform feasibility studies, and determine the effectiveness of new design concepts or test methods
• Support the development of Supplier Agreements, Quality Agreements, and Operational Frameworks

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Sit; use hands to finger, handle or feel objects, tools, or controls.
• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
• Lifting/pushing/pulling and carrying products weighing up to 45 pounds
• Potential Exposure to moving mechanical parts, vibration, and/or moderate noise levels.
• Potential Exposure to hazardous chemicals or other materials.
• Safety Shoes compliant with site specific policies/procedures must be worn in…