Senior Manufacturing Engineer

Job Title: Manufacturing Engineer 5

Location: 10210 Genetic Center Drive San Diego CA

Duration: 12 months

Shift: 1^st Shift

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

Job Description:

Hologic Overview

Hologic is one of the worlds most innovative medical technology companies and a global champion of womens 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 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

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. QSRs ISO ISO 13485 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 relationships
• 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
• Creates an open and accessible environment that encourages flow of information
• Writes clearly and concisely. Composes information based on the specified audience
• Continuously seeks new knowledge and rapidly assimilates it into the organization
• Establishes and models standards that guarantee exceptional quality
• Takes action without being prompted
• Maintains an appropriate focus on outcomes and accomplishments. Persists until the objectives are achieved and conveys a sense of urgency when appropriate
• Awareness of their own behaviors and its impact on others
• Readily offers opinions and takes action. Willing to challenge others appropriately when required
• Effective in flexing individual style to direct collaborate persuade or motivate as the situation requires
• Develops expertise and shares functional knowledge with others
• Understand formal and informal policies and operational frameworks
• Shares 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 Engineering
• Lean Manufacturing and/or Six-Sigma Certification preferred but not required
• Certified Quality Engineering Certification preferred but not required

Experience

• 12 years of Biotech / Medical Device / Pharmaceutical industry experience
• High volume manufacturing experience in a regulated environment
• High proficiency with MS Office MS Project and MS SharePoint
• High proficiency with Minitab or other statistical analysis software
• Working knowledge of manufacturing automation systems and design practices
• Working knowledge of cGMP GAMP ISO 13485 and FDA 21 CFR Part 820