Process Development Engineer, Chip Consumables

Primary Duties & Responsibilities:

* Develops and manages the manufacturing process of the Company's consumable nanochannel array cartridge.
* Creates, evaluates and makes final decision between multiple process technologies
* Makes creative proof-of-concept processes to assist Design Engineering in product iterations
* Assists in the development of new business estimates for products including labor content and capital requirements
* Assists in identifying and mitigating key program risks
* Creates written protocols and reports to support the validation process
* Provides documentation to support FDA/ISO quality and to develop manufacturing processes and procedures
* Directs technical support staff including technicians, junior engineers and tooling support staff

Knowledge, Skills and Abilities Required:

Technical skills: Demonstrated understanding of Design for Manufacturability. Experience with manufacturing sensitive consumables for the life-science industry. Experience developing manufacturing processes that involve fluorescent microscopy, semiconductor manufacturing and packaging and microfluidic devices is desirable. Ability to work directly with suppliers and foundries. Experience in use of statistical tools and analysis and GMP experience also required.

Communication skills: This position requires a critical thinker with strong organizational skills as well as excellent written and verbal communication skills.

Demonstrates traits consistent with the company culture, drive and perseverance in accomplishing goals; sense of responsibility and integrity; effectiveness as a team member; adaptability to new projects; planning and organizational skills; resourcefulness; determination and motivation to accept and complete tasks; and enthusiasm for the business and their work.

Requirements

Education and Experience Required:
Requires BS degree in Process Engineering or Manufacturing Engineering with a minimum of 8 years experience in the medical device industry.

Preferred Qualifications:
* Experience using AutoCAD and/or SolidWorks
* Experience with rapid prototyping of parts
* Experience with medical device assembly and packaging systems
* Knowledge of and experience with semiconductor manufacturing and packaging processes
* Knowledge of and experience in microfluidic device manufacturing
* Expertise in the development of medical device molding/over-molding processes
* Experience with small, complex medical device assemblies in a clean room environment.

To find out more about Real Staffing please visit www.realstaffing.com