Senior Manufacturing Engineer/Manager

long-term implanted sensors and delivery systems

MicroCHIPS, Inc. is pioneering 'smart' implantable devices to create sophisticated monitoring and therapy systems. Based on breakthrough technologies originally developed at MIT, MicroCHIPS' patented technologies have the ability to revolutionize today's medical implants by adding unique monitoring and targeted therapeutic capabilities designed to improve patient care in chronic disease states. MicroCHIPS' devices under development are based on advances the company has made in the fields of microelectromechanical systems (MEMS), implant technologies, drug formulation and chemical sensing.

MicroCHIPS, Inc is seeking a senior manufacturing engineer to lead the fabrication and assembly efforts for an implantable diagnostic medical device. The ideal candidate will have experience supporting R&D efforts, new product introduction, and establishing systems to support manufacturing a Class III implantable device consistent with FDA good manufacturing practices. This position may also grow into a manufacturing engineering management position as MicroCHIPS enters the product commercialization phase.

Responsibilities:

· Support the R&D team in the development of new implantable device

Conceive novel fabrication and assembly techniques (incorporate design for manufacturing and assembly methods)

Identify and interface with appropriate manufacturing partners (for electromechanical and micro electromechanical systems as well as potential contract manufactures)

Lead prototype efforts

Document manufacturing plans, process failure modes and effects analysis, and protocols

· Define the manufacturing systems and operating procedures required for a Class III medical device

· Define and lead the creation of a controlled manufacturing facility

· Assist in establishing systems for ISO 13485 certification.

Skills/Requirements:

· Bachelor of Science in mechanical or manufacturing engineering. Master of Science a plus.

· 10 + years industrial experience in medical device manufacturing

· Knowledge in Class II and Class III medical device manufacturing (manufacturing systems as well as processes)

· Process knowledge should include: electromechanical assembly, microscopy assisted assembly, precision deposition methods, injection molded plastic components, laser welding of titanium, as well as hermetic assembly techniques. Exposure to microfabrication techniques a plus.

· Extensive experience with verification and validation of manufacturing processes

· Training and experience in Six Sigma and Lean Manufacturing principles

· Intellectual curiosity, attention to detail and a team-oriented work approach are essential.

In addition to fostering an environment that cultivates and expands the professional skills of our team members, MicroCHIPS is committed to providing a well balanced, competitive compensation and benefits package for our employees and their families. This package includes: Competitive cash compensation, Stock options, Health and life insurance, 401K retirement plan, and generous holiday, vacation, and sick days.

To apply, please forward your resume and cover letter to careers@mchips.com

MicroCHIPS, 6-B Preston Court, Bedford, MA 01730 www.mchips.com