Project Engineer Medical Device

Affinity Medical a Molex company, has an exciting opportunity for a Medical Device “Project Engineer” to be a part of our Engineering Team.  Affinity Medical designs, develops and manufactures high quality interconnect systems for the medical industry. Our culture inspires profit, growth, enthusiasm and professionalism with our people, suppliers and customers.  This is a unique opportunity with exceptional growth in a fast pace and exciting environment.

The “Project Engineer” plans and performs project management and sustaining engineering functions within the Engineering department.  

ESSENTIAL DUTIES AND RESPONSIBILITIES INLUDE THE FOLLOWING:
• Independently determines project scope, develops a preliminary plan of investigation, and determines   project specifications such as cost, time and sample requirements by analyzing customer input.
• Work with the engineering team to ensure specification compliance in the areas of; design system performance and delivery criteria.
• Ability to design complex assemblies for manufacturing using Solidworks.
• Ability to coordinate mold tool manufacturing, design and qualification. Familiarity with injection molding process is a must.
• Develop work instructions and assembly/component level drawings
• Participate in design reviews internally and with external suppliers and customers.
•Communicates project status and results to customers through frequent contact and communication efforts.
• Familiarity with ISO 13485, FDA Medical Device Directives and other applicable standards.
• Creation and maintenance of technical files including, design history folders.
• Investigation of new materials/processes/equipment to further broaden the company's capabilities.
• Sustaining engineering activities as required.
• Troubleshooting and root cause investigations.
• Experience with creating and executing qualification protocols such as design verification tests, installation/operational qualifications, performance/process qualifications.
• Familiarity with electrical diagrams and circuit design.
• Responsible for conveying project costs and negotiate completion date of projects to the Engineering Manager.
• Integrates continuous improvement concepts and techniques into all aspects of the position.
• Collaborates with Engineering, Production and Sales to identify solutions to cost improvements and to ensure all changes are properly documented.
• Interface with all internal departments.

QUALIFICATIONS:
Education and/or experience:
1. Bachelor's degree in Engineering or related field.
2. Minimum of three years previous experience in an Engineering role with hands on experience.
3. Must be proficient in using Solidworks and Auto CAD design software.
4. Must be mechanically inclined and have a working knowledge of mechanical design.
5. Demonstrate the ability to apply project-handling concepts.
6. Must be energetic, self-starter able to work without constant supervision.

Qualified Candidates - Please submit resume and salary history to jobs@affinitymedical.com