Senior Manufacturing Engineer

Senior Manufacturing Engineer

The Senior Manufacturing Engineer plans, directs, and coordinates manufacturing processes for medical device products, and supports Operations in a way to assure a quality product is produced in a timely manner. The Production Engineer works with Operations, Quality Assurance and Regulatory Affairs to improve existing product designs and processes to increase throughput, decrease operational costs, or improve quality.

Responsibilities

- Work with Operations Managers and outside Vendors to create methods/machines to help with capacity of products.

- Work with Product Development Engineers to develop processes for new products.

- Work with Operations, Accounting, and Global Product Managers to increase profit margins of current products which do not meet company requirements.

- Train all relevant personnel on new processes.

- Document cost savings.

- Write and execute validation protocols.

- Assure projects follow design controls established by QSPs (Quality System Procedures).

- Provide support to the calibration department in writing/performing calibration procedures.

- Work with Quality Assurance and Product Development to verify/validate critical processes or products.

- Work with management to establish project timeliness, and project justification.

- Act as resource for operational departments for materials, equipment and process upgrades.

- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.

- Prepare and maintain accurate documentation consistent with the requirements of pertinent regulations and Cook's Quality Management System where applicable.

- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.

- Must strictly adhere to safety requirements.

- Maintain regular and punctual attendance.

- Must maintain company quality and quantity standards.

- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.

- Ability to remain calm and receptive in fast paced situations.

Qualifications

Bachelor's Degree in Engineering- 5+ Manufacturing Engineering years experience, preferably in medical device

Physical Requirements:

- Works under general office environmental conditions.

- Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.

- Frequently required to stand, walk, and communicate.

- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.