Manufacturing Engineer

Job description

SUMMARY OF POSITION:

As part of Medtronic Contract and Regional Manufacturing team, the Manufacturing Engineer will work as a team member with the Artwork, Packaging, Quality, Engineering, Planning, and Contract & Regional Manufacturing Organization to ensure the successful transfer of Artwork updates and ongoing production of finished Medical Devices at Contract Manufacturers (CM’s) globally. The manufacturing engineer will manage projects utilizing CDPs as required. Applicant must demonstrate the ability to deliver quality, innovative, cost-effective and timely solutions in a multiple project environment.

ESSENTIAL FUNCTIONS:
1. Manage all technical aspects of the ECO and the CDP process. Ability to multitask to lead a wide range of engineering changes to support the various Medical Supplies Franchise product families.
2. Lead and participate in communications and meetings between all functional groups; Quality, Supply chain, R&D, Packaging, Marketing, technical documentation, Sourcing, Corporate Engineering, and UDI Team based on project requirements.
3. Support and lead cost reduction and transfer projects.
4. Ensure artwork updates are implemented correctly at contract manufacturers’ globally.
5. Provide technical support and guidance to Contract Manufacturer.
6. Develop and maintain project schedules, budgets, and progress reports.
7. Candidate must have the ability to work independently and be able to communicate effectively with team members.
8. Ability to meet at off hours to support of Contract Manufacturers located across the globe with global time zone differences.

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
1. Ensures adherence to product specifications, industry standards, and quality and regulatory procedures and requirements.
2. Other duties as assigned with or without accommodation.

WORKING CONDITIONS:
Normal Office conditions, with time spent working on manufacturing shop floors.

DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Desired profile

MINIMUM REQUIREMENTS:

Education: B.S degree.
Experience: A minimum of 3-5 years of experience working in medical device manufacturing preferred.

referred Skills/Qualifications: Familiar with MS Office; organized, self-starter with problem solving skills
Familiarity with Agile system, ECO and Artwork
Familiarity with Medtronic regulations, Change Control System
Familiarity with project management techniques.
Familiarity with process verification and validation.
Lean Manufacturing/Six Sigma concepts and understanding.
Knowledge of FDA Quality Systems Regulations and ISO Quality Systems.

Skills/Competencies: Results driven.
Self-directed with the ability to develop, facilitate and gain consensus in the deployment of manufacturing and test strategies.
Effective communication skills with superiors, subordinates, and contractors.

Other Skills: Ability to adapt to evolving projects requirements.
Problem solving skills.
Demonstrate flexibility, adaptability and integrity when making decisions.
Ability to travel international. (Approximately 10-20%)

ORGANIZATIONAL RELATIONSHIPS/SCOPE:
This position is an individual contributor position with project responsibilities.
The position reports to the Contract Manufacturing Engineering Manager and will be located at the Kenmex Plant in Tijuana, Mexico.