Summary

The Sr. Principal Advanced Manufacturing Engineer is responsible for managing the pilot manufacturing operations of the company.  The individual will be responsible for process development, as well as all other aspects of prototype and short run production needs at Apnex Medical.  In addition, this position requires close cooperation with product design engineers and involves assisting with product design to ensure manufacturability.

Essential Duties and Responsibilities

The Sr. Principal Advanced Manufacturing Engineer shall:

1.    Plan, develop and implement the strategy for operational management and development so as to meet organizational performance plans within agreed budgets and timelines.

2.    Determine the financial and human resources required to execute the operational goals of the company. 

3.    Work closely with key suppliers, including contract manufacturers, to assure that the suppliers can provide quality products in a timely manner.

4.    Contribute to the evaluation and development of operational strategy and performance in cooperation with senior management.

5.    Establish procedures for maintaining staff to high standards of manufacturing operations, product quality, reliability and safety.

6.    Monitor, measure and report on operational issues, opportunities and development plans and achievements within agreed formats and timelines to senior management.

The above statements are intended to describe the general nature and level of work being performed.  They are not intended to be construed as an exhaustive list of all job responsibilities and duties.

Qualification Requirements

·         Education and / or Experience

·         Bachelor of Science, preferably in an engineering discipline

·         Strong background in process development, especially in the area of implantable leads assembly.

·         A minimum of 10 -15 years experience in the operations department of a medical device company(s).

·         Experience in setting up and operating pilot or low volume medical device production lines. 

·         Experience working with suppliers in providing completed medical devices.

·         Extensive knowledge of manufacturing, product development, quality, clinical, and regulatory.

·         Knowledge of medical regulatory standards.

Other Essential Skills and Abilities

·         Ability to determine production demands and process capabilities throughout the development cycle of the project.

·         Outstanding planning and organizational competency, leadership and mentoring skills.

·         Ability to communicate well with the project team and management.

·         Ability to establish working relationships with key suppliers, contract vendors and consultants.

·         Understanding of process validation test activities required for regulatory submissions.