Senior Manufacturing Engineer

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 play a key role within our organization. If you are ready to take the next step in your career, we would like to talk with you.

RESPONSIBILITIES
* Manage the successful introduction of new strip and meter products into production.
* Responsible for the coordination and execution FMEA, DFMEA, Risk Analysis, and design review meetings.
* Perform, participate, and coordinate process validation and change verification activities, ensuring conformity to ISO and FDA requirements.
* Work with suppliers and Quality Engineering to document manufacturing process flow, assembly methods and IQ, OQ, and PQ of high volume automation production equipment and processes in accordance with ISO 13485 and FDA requirements.
* Work with suppliers and Quality Engineering to develop and document all manufacturing documentation, B.O.M.'s, work instructions, quality reporting system, and failure investigation activities.
* Coordinate all activities associated with pilot, preproduction, "first article build" of new products, packaging and labeling to ensure that fabricated and kitted items are traceable to documented specifications and design requirements at the time of product release.
* Participate in Master Production Planning and Scheduling activity. Assist Materials Manager in coordinating and holding regular planning scheduling meetings with suppliers and customers.
* Provide support of manufacturing process, yield reports, loss, and change order activity.
* Support prototyping activities of new product development.

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

QUALIFICATIONS
* BS in Manufacturing Engineering or equivalent, 5+ years experience in high volume medical product manufacturing and packaging.
* Demonstrated experience in documentation control systems.
* Demonstrated ability to communicate ideas and concepts both efficiently and effectively.

© 2004-2009 MedDeviceJobs.com | Contact Us | UK Site