Manufacturing Project Engineer
| Company: | AgaMatrix, Inc. View Company Profile | See all Jobs at this Company |
|---|---|
| Job Location: | 10 Manor Parkway, Salem, New Hampshire 03079 |
| Pay: | Not Specified |
| Date Posted: | July 16, 2010 |
| Job ID: | 7147 |
| Required Education: | Bachelor's Degree |
| Required Experience: | 10+ to 15 Years |
Job Description
AgaMatrix invents, manufactures, and markets blood glucose monitoring (BGM) and diabetes management products. Based on its proprietary WaveSense dynamic electrochemistry technology, their meters are more accurate and they can improve manufacturing yields, a key industry challenge. AgaMatrix has shipped >1 million meters and almost 1 billion biosensors (strips) across several FDA-cleared product lines in this $9 billion market.
The company has >100 patents and is known for its user-centric product design. We are driven, passionate people who value innovation and perseverance, while still enjoying a collegial, familial atmosphere where colleagues are helpful both in and out of the office. Our people come from a variety of backgrounds from biochemistry and algorithm design to industrial design and regulatory affairs, so you will have the chance to learn from many different disciplines.
Recently, sanofi-aventis, the world's 4th largest pharmaceutical company, entered into a long-term relationship with AgaMatrix to market and sell a series of diabetes management products manufactured exclusively for them, selecting the company based on their accuracy and innovativeness. In recent years, AgaMatrix has broken ground in the connected health space with several hardware, software, and web services offerings, including the world's first and best-rated diabetes iPhone App by a BGM maker, and the world's first BGM-to-iPhone download system. The company is based in Salem, NH, half an hour north of Boston.
WE ARE GROWING! This new position is a tremendous opportunity to have a high visibility role within our organization. If you are ready to take the next step in your career, we would like to talk with you.
RESPONSIBILITIES
* Creates and designs layout of equipment and workspace for manufacturing equipment and controls.
* Manages and oversees efforts for the design and implementation of manufacturing equipment and system controls.
* Direct participation to ensure the successful introduction of new biosensor from prototype into production.
* Manufacturing responsibility for the operation and control of biosensor manufacturing equipment line. Including operation, service, and debugging system problems.
* Perform and participate in process validation and change verification activities, ensuring conformity to ISO and FDA requirements.
* Work with Quality Engineering to document and development manufacturing process flow, assembly methods and IQ, OQ, and PQ of production equipment in accordance with ISO 13485 and FDA requirements.
* Work with Quality Engineering to develop and document manufacturing work instructions, quality reporting system and failure investigation activities.
* Coordinate activities associated with "first article build" of new products, packaging, and labeling requirements to ensure that fabricated and kitted items are traceable to documented specifications and design requirements at the time of product release.
* Manage biosensor manufacturing activities.
* Interfaces and manages vendors, manufacturing facilities, and internal groups to resolve design and manufacturing issues.
* Provide oversight of the manufacturing process, yield reports, loss, and change orders.
* Hands on engineering and system design, implementation, and debugging.
COMPENSATION and CONTACT
AgaMatrix is pleased to reward our associates with competitive compensation packages that include paid time off, health, dental, and life insurance, LTD, and 401k with company match.
Start your journey at AgaMatrix by forwarding your resume to hr@agamatrix.com with "response to job posting" along with appropriate "job title" in the subject field. Telling us why you would be a good match for AgaMatrix along with your salary requirements will speed the process.
AgaMatrix is proud to be an Equal Opportunity Employer.
Job Requirements
* BS in Mechanical Engineering or equivalent, 10-15 years experience in high volume medical product disposables manufacturing.
* Demonstrated experience in manufacturing equipment, design, operation, debugging, and designing electronically controlled mechanical assemblies and systems.
* Demonstrated experience with SolidWorks or other 3D-CAD system.
* Demonstrated ability to diagnose design products with creative and unique solutions.
* Demonstrated ability to communicate ideas and concepts both efficiently and effectively.
* Solid understanding of mechanical and systems control.