Job Description

Position Summary

The Plastics Consumables Engineer 3 will be an essential team member supporting internal manufacturing by managing and validating projects, often with suppliers, for new injection molded plastic consumables, assemblies, and related automation systems. Projects begin at design concept and conclude with production acceptance. Responsibilities include supplier process development and validation, technical evaluation, testing, statistical analysis, qualification, and ongoing process improvement, working in close partnership with R&D on manufacturing design and design transfer. This position also involves sustaining product support to ensure quality products, continuity of supply, and cost savings initiatives. The role incorporates various engineering disciplines, including Manufacturing Engineering, Mechanical Engineering, and Supplier Quality Engineering.

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.

Capacity and Improvement Projects:
• Manage injection molded plastic consumables, molded and assembled components, and related automation systems, including finished and semi-finished forms.
• Lead initiatives that may involve injection molds, tooling, consumables automation, and assembly equipment such as leak testers, robotics, and part-handling or separation systems.
• Lead technical evaluation and qualification of new and existing plastics and consumables suppliers, including process capability, control strategies, and manufacturing readiness.
• Establish validation requirements and develop or approve IQ/OQ/PQ documentation at suppliers for injection molds, associated auxiliary equipment, and automation systems.
• Review supplier process flow, PFMEA, control plans, inspection methods, and validation packages to ensure robust and scalable production.
• Support first article inspection, process qualification, and production acceptance for supplier-manufactured consumables and components.
• Lead defect and failure analysis for molded consumables, including short shots, flash, sink, warpage, dimensional drift, contamination, weld or knit line issues, and cosmetic defects that impact function.
• Develop inspection and measurement techniques, including fixtures, gauges, and metrology approaches for dimensional and functional verification.
• Apply working knowledge of in vitro diagnostic (IVD) products, cGMP and FDA regulatory compliance, and industry guidance initiatives such as MDSAP.
• Continuously improve internal and external supplier processes to reduce time to market, enhance product quality, and decrease costs.

New Product Development
• Support the design transfer process from R&D to Operations, which may include defining consumable and component requirements, qualifying molded parts and assemblies, labeling, and establishing supplier manufacturing methods.
• Partner with R&D early in development to provide Design for Manufacturing and Design for Assembly feedback on concept and prototype consumables, driving robust, consistent, and manufacturable processes.
• Provide material and process alternatives based on application requirements, including tooling and gating strategy, molding process window, assembly method, and cosmetic and functional requirements, in partnership with R&D and Quality.
• Collaborate with suppliers on prototype development, manufacturability assessments, and process readiness for scale-up.

Sustaining Product Support:
• Support complex cross-functional investigations.
• Perform root cause analysis and recommend corrective actions for non-conforming events or manufacturing concerns using risk-based methods.
• Participate in ideation activities, cause and effect analysis, process variables mapping, and pFMEAs.
• Initiate and/or review change orders related to suppliers, collaborating with the appropriate departments and personnel.
• Actively manage tooling, molds, fixtures, and process maintenance with suppliers, and monitor performance trends.
• Support supplier quality and process improvements related to dimensional variation, cosmetic condition, fit, function, and long-term process capability.

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.

Qualifications

Education
• BA or BS degree, preferred 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 Engineer Certification preferred but not required.

Experience and Skills
• 5-8+ years of Biotech, Medical Device, or Pharmaceutical industry experience.
• Plastic and injection molded consumables manufacturing experience, low to high volume.
• Experience working with custom injection molding and consumables automation suppliers and processes such as injection molding, tooling and mold qualification, automated assembly, leak and functional testing, and packaging interfaces.
• Experience with process validation (IQ/OQ/PQ), first article inspection, and measurement systems analysis for molded components.
• 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.
• Working knowledge of engineering drawings, GD&T, tolerance analysis, and inspection methodologies.

Travel
• Approximately 0-4 times annually, usually less than one week in duration for each occurrence.

Must follow all applicable FDA regulations and ISO requirements.

The annualized base salary range for this role is $97,000 to $140,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand..

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

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