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. Job Description Hologic Overview 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. Job Summary Hologic is seeking a Manufacturing Engineer responsible for providing engineering support services including automation development, evaluation, purchase, installation, and qualification of new manufacturing equipment. Essential Duties And Responsibilities 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 MDDAPIndependently lead multiple custom automation system or new consumable injection molding projects simultaneouslyIndependently lead engineering functions such as: Design Reviews, Measurement Systems Analysis, Design of Experiments, feasibility studies, process development, acceptance testing, and risk managementAuthor documents to develop effective design and control plansEstablish 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 reportsIndependently lead the creation of RFQ/URS documentation for injection molds and/or consumables automation systemsGather 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 proposalsContinuously improve internal and external supplier processes to reduce the time to market, enhance product quality, and decrease costsDevelop and/or implement continuous improvement ideas and participate in the strategic Operations plansLead the design transfer process as a core team representative from R&D to Operations, which may include automation, consumables, labeling, assembly, and supplier methodsManufacturing team lead for a newly acquired site or new supplier to gain process knowledge, which would support the transfer of consumables manufacturingLead complex cross-functional investigationsLead root cause analysis meetings and recommend corrective actions for non-conforming events or manufacturing concerns utilizing risk-based approach methodsLead others in ideation activities such as cause-and-effect analysis, process variables mapping, and pFMEAsActively manage asset maintenance with suppliers and monitor performance trendsGenerate innovative possibilities, perform feasibility studies, and determine the effectiveness of new design concepts or test methodsSupport the development of Supplier Agreements, Quality Agreements, and Operational Frameworks Physical Demands 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 designated areas Potential Exposure to blood. Other (please specify): Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required: Experience with cGMP, manufacturing, machine operations, and data entry.Working knowledge of safety regulations, federal regulations, and other regulations, e.g. QSR s, ISO, ISO 13485, etc. in a laboratory environment.Experience with automated and semi-automated equipment and processes. Detail oriented with strong verbal and written communication skills.Demonstrated ability to follow detailed directions in a manufacturing GMP environment.Lean manufacturing certification and experience strongly desired.Understanding of manufacturing systems, processes, and equipment (documentation, compliance, Safety, change control, time and attendance, etc.). Solid understanding of the product and manufacturing processes. Excellent computer skills. Competencies Establishes and maintains productive working relationshipsIdentifies problems, solves them, acts decisively, and shows good judgmentPlans and organizes work efficiently to manage time wisely. Prioritizes tasks within a dynamic and fast-paced working environmentExhibits a high level of energy and is self-motivated to sustain ambitious workCreates an open and accessible environment that encourages flow of informationWrites clearly and concisely. Composes information based on the specified audienceContinuously seeks new knowledge and rapidly assimilates it into the organizationEstablishes and models standards that guarantee exceptional qualityTakes action without being promptedMaintains an appropriate focus on outcomes and accomplishments. Persists until the objectives are achieved and conveys a sense of urgency when appropriateAwareness of their own behaviors and its impact on othersReadily offers opinions and takes action. Willing to challenge others appropriately when requiredEffective in flexing individual style to direct, collaborate, persuade, or motivate as the situation requiresDevelops expertise and shares functional knowledge with othersUnderstand formal and informal policies and operational frameworksShares resources, responds to requests from other departments, and engages with larger organizational objectives Education BA or BS degree, MA preferred. Field of study in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Quality Engineering, or Validation EngineeringLean Manufacturing and/or Six-Sigma Certification preferred but not requiredCertified Quality Engineering Certification preferred but not required Experience 12+ years of Biotech / Medical Device / Pharmaceutical industry experienceHigh volume manufacturing experience in a regulated environmentHigh proficiency with MS Office, MS Project, and MS SharePointHigh proficiency with Minitab or other statistical analysis softwareWorking knowledge of manufacturing automation systems and design practicesWorking knowledge of cGMP, GAMP, ISO 13485, and FDA 21 CFR, Part 820