Value Improvement Project Engineer 2

Hologic•Newark, NJ

11d•$78,600 - $120,000

About The Position

Why join Hologic: You will have the opportunity to get in on the ground floor at a high growth world class manufacturing facility working on life-saving medical devices with potential for future growth. This is a great opportunity to enhance your manufacturing operation skills and knowledge to further your career. What to expect: The Value Improvement Project Engineer is a key member of the engineering team responsible for supporting the execution of value improvement projects into manufacturing. This is a hands-on role expected to be the technical lead/co-lead to coordinate departmental or cross-functional teams, drive the execution of projects from initial scoping through implementation. This may include new supplier qualifications, implementing process improvements, executing validations, updating documentation (assembly procedures, Bills of Material and technical documentation) for the successful implementation value improvement initiatives to improve product cost. The Project Engineer will also directly interact with internal and external stakeholders including suppliers, Global Sourcing, R&D and the Operations teams to provide technical guidance and leadership in executing activities. This role will require a combination of engineering and project management skills to execute value improvement projects successfully. Developing professional expertise, applies company policies and procedures to resolve a variety of issues. Normally receives general instructions on routine work, detailed instructions on new projects or assignments. Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships.

Requirements

2-5 Years Preferred Minimum Non-Technical Degree
1-2 Years with Technical Bachelor’s Degree, 0-2 Years with Master’s Degree

Responsibilities

Actively manages projects from initiation through completion including completing cost: benefit analysis, defining project scope, creating and maintaining project schedule, and providing updates to stakeholders.
Conduct product cost analysis of tact time, labor and burdened costs for input into COGS.
Completes analysis of projects to assess resource allocation to identify and prioritize projects based on value proposition.
Participates in and supports activities such as Standard Operating Procedures and Agile creation and maintenance, Defect Reviews, DFMEA Meetings, DFMEA document review, Kaizen Events, and Process Enhancement Activities.
Continuously work to improve manufacturing methods, efficiency, and product quality.
Participates in design reviews and provides technical support to R&D on manufacturing processes.
Collaborate with R&D on BOM structure, including subassembly breakout and make/buy determinations.
Collaborates with production to deliver a manufacturing process which incorporates production requirements into manufacturing process design.
Active contributor in design implementation projects translating improved product designs from design engineering to manufacturing.
Define and develop assembly and test methods as they relate to design transfers and/or new supplier qualification.
Specify and design all necessary tools, equipment, and fixtures required to support projects.
Creates work instructions, bills of material, technical drawings and manufacturing documentation.
Creates and manages engineering change orders through the implementation of the project.
Develops, verifies, and validates process for manufacturing.
Creates and maintains process flowcharts, Risk Files & Process Control plans.
Participate in risk mitigations and risk management activities related to manufacturing improvements including PFMEAs.
Coordinates and develops user manuals, training materials and other documents required for knowledge transfer to process owner.
Monitor initial production run quality and output and uses problem solving skills to identify trends, investigate problems and perform root cause analysis.
Recommends and implements corrective action plans as it relates to projects.
Evaluate and develop process controls data for trending analysis.
Provides regular communication and updates on project status.
Provide inputs into analysis for new supplier selections based on core competencies and experience
Actively supports and adheres to the Quality Policy and QMS procedures following Good Documentation Practices (GDP).
Must follow all applicable FDA regulations and ISO requirements.