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Associate Manufacturing Engineer

2 months ago

Mahwah, United States Ledgent Technology Full time

Medical Device client is seeking an Operations Engineer

Associate Manufacturing Engineer - Onsite

Pay Rate Range: $33.33/hr. - $43.33/hr.

Description/Comment:

*Responsible for process Gantt commitments within time, resource, and budget constraints

*Create individual manufacturing process timeline partnership with the process SMEs to be linked to overall project timeline

*Support vendor acceptance activities (engineering drawings, FAT, SAT etc.)

*Support weekly meetings with vendors, track meeting minutes and actions for individual processes

*Develop Global Initiated Assessment (GIA) in partnership with Quality Engineers and divisional resources required for applicable assessments

*Facilitate operator training and lead review and approval of documentation updates scoped in through the GIA process

*Formulate and execute process and equipment validations and capability studies in collaboration with process SMEs.

*Execute FAI in collaboration with process SME

*Lead development and execution of decommissioning activities

Additional Job Details:

POSITION SUMMARY:

As Operations Engineer with the Operations team, you will provide manufacturing engineering leadership and lead projects for assigned cells within our Mahwah, NJ site. You will work closely with Quality Assurance, Suppliers, Advanced Operations, and Product Development on initiatives that drive toward best practices and support business objectives.

KEY AREAS OF RESPONSIBILITY:

What do we want:

* Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

* Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

* Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

Technical Responsibilities:

* Develop and manage project timelines within a cross-functional team

* Define & implement specific solutions to technical problems, completing the tasks associated with such projects and writing reports that clearly document the results

* Work closely with Operations, Engineering Services, and Quality to resolve in-house and supplier quality problems using established problem-solving methodologies

* Actively participate and lead teams to support new product and process design and development activities

* Lead and participate in the development and improvement of the manufacturing process for existing and new products

* Review & approve inspection plans, routers, product drawings, as well as non-conforming material, and system documentation

* Facilitate quality remediation, gap closure through partnership with cell Quality Engineers.

* Participate in development, review & approval process, and equipment validation/qualifications

* Initiate & support NCR and CAPA initiatives

* Develop and execution equipment validations EQ, OQ, PQ and Procedure creations/updates

Preferred Skills / Engineering tools:

* Manufacturing Equipment Validation Experience - ValGenesis

* Change Control Experience - OnePLM/Windchill

* NC/CAPA Experience - TrackWise

* Equipment Work Order Experience


Skill/Role

Level

Years

Preference

Manufacturing Staff

Intermediate

2.0

Required


Desired Skills and Experience

Gantt charts, Equipment Validations, Documentaion, Manufacturing Processes, CAPA, NCR, ValGenesis, OnePLM/Windchill, TrackWise, Work Orders

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.