Manufacturing Engineer 2

Hologic•Marlborough, MA

About The Position

Hologic is a global leader in women's health, dedicated to advancing diagnostic, detection, and surgical solutions. We are seeking a Senior Level Metal Materials Engineer to join our team. This role is crucial for supporting internal manufacturing by managing and validating projects, often in collaboration with suppliers, for new custom metal materials, fabricated components, and related manufacturing processes. The scope of projects spans from design concept to production acceptance. Responsibilities include supplier process development, technical evaluation, testing, statistical analysis, qualification, and continuous process improvement. The position also provides sustaining product support to ensure product quality, supply continuity, and cost savings. This role integrates various engineering disciplines, including Manufacturing, Mechanical, Materials, and Supplier Quality Engineering.

Requirements

BA or BS degree, preferred in Manufacturing Engineering, Mechanical Engineering, Materials Engineering, Industrial Engineering, Quality Engineering, or Validation Engineering.
Must follow all applicable FDA regulations and ISO requirements.

Nice To Haves

Lean Manufacturing and/or Six-Sigma Certification preferred but not required.
Certified Quality Engineering Certification preferred but not required.

Responsibilities

Manage metal raw materials, fabricated components, and assemblies, including finished and semi-finished forms.
Lead initiatives involving sheet, bar, tube, foil, wire, or custom alloy supply materials.
Lead initiatives involving machined, stamped, formed, welded, or finished parts.
Lead technical evaluation and qualification of new and existing metal suppliers, including process capability, control strategies, and manufacturing readiness.
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 activities for supplier-manufactured metal materials and components.
Lead materials failure and defect analysis, including corrosion, cracking, burrs, contamination, hardness issues, dimensional drift, cosmetic defects that impact function, and surface finish problems.
Apply mechanical understanding of custom manufacturing systems and metal component fabrication processes and their impact on performance.
Develop inspection and measurement techniques, including fixtures, gauges, and metrology approaches for dimensional, surface, and functional verification.
Continuously improve internal and external supplier processes to reduce time to market, enhance product quality, and decrease costs.
Support the design transfer process from R&D to Operations, which may include defining material requirements, qualifying metal raw materials and assemblies, and establishing supplier manufacturing methods.
Provide Design for Manufacturing feedback based on concepts, drawings, and prototype components to achieve robust and consistent manufacturing processes.
Provide material and process alternatives based on application requirements, including alloy selection, forming method, machining approach, joining method, surface finish, corrosion resistance, and cleanliness requirements.
Collaborate with suppliers on prototype development, manufacturability assessments, and process readiness for scale-up.
Support complex cross-functional investigations.
Perform root cause analysis and recommend corrective actions for non-conforming events or manufacturing concerns utilizing risk-based approach methods.
Participate in ideation activities, cause and effect analysis, process variables mapping, and pFMEAs.
Initiate and/or review change orders related to suppliers, including collaborating with appropriate departments and personnel.
Actively manage tooling, fixtures, and process maintenance with suppliers and monitor performance trends.
Support supplier quality and process improvements related to dimensional variation, surface condition, corrosion, fit, function, and long-term process capability.
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.