Manufacturing Engineer

Interested Candidates can send their resumes to ravi@starkassociatesllc.com

Job Title: Manufacturing Engineer

Location: Westford, MA (Onsite only)

Duration: Long Term

Roles & Responsibilities :

Should possess 02- 03 years of Change management experience

Manage projects which include new production equipment, process improvements and cost reductions while supporting new product introductions. Provide guidance to other engineers and technicians.

Perform projects which include new production equipment installation and qualification, process improvements, yield improvements, and cost reductions while supporting daily production activities.

Collect and analyze in process data to evaluate capability and determine areas for process improvement.

Drive process improvements and validations through manufacturing implementation and update pFMEAs and master validation plan as required. Author process validation protocols and reports. Including but not limited to equipment IQ, process OQ, process PQ, and product PPQ.

Provide direct technical support on production issues (e.g. part & assembled product quality dispositions, interim containment actions, root cause analysis, resolution planning, validation, & implementation) under NCMR or CAPA. Provide guidance to other engineers and technicians.

Coordinate the design, procurement, build and debug of tooling, machinery, and test equipment

Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts like Value Stream Mapping, 5S, and Visual Workplace.

Work with cross-functional teams to transfer new products efficiently and effectively into manufacturing.

Work with various internal and external organizations to optimize manufacturing processes or resolving technical issues with w/ongoing products or new products.

Provide technical support to manufacturing and QA to improve productivity and reduce costs.

Participate as a manufacturing lead and/or support a lead on cross-functional core teams.

Performs other related duties and responsibilities, on occasion, as assigned.

Preferred

Medical device experience strongly preferred, International manufacturing experience preferred. Knowledge of ISO and/or FDA quality system regulations as it pertains to design transfer and process control preferred.

4 + years experience in Manufacturing involving handling multiple projects, strategically prioritize activities across functional teams within Operations/Manufacturing

BS or MS in Mechanical Engineering preferred