Quality Engineering 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 is seeking a manager to lead the quality engineering group. The candidate will support the research and development team during the development phase, and lead the creation and implementation of systems and documentation consistent with the FDA’s good manufacturing practices and leading to ISO 13485 certification.

Responsibilities:

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

Define quality plans and lead the effort for risk management and assessment, failure modes and effects analysis, and other quality specific deliverables

Review and audit the development team, including the project plan, specifications, protocols, and the design history file

· Manage the documentation control supervisor, oversee their efforts, and interface with external quality consultants

· Support manufacturing engineering in qualifying critical suppliers

· Identify and help establish systems for the creation of a controlled manufacturing facility

· Lead the effort for establishing systems and lead audits for ISO 13485 certification.

Skills/Requirements:

· Bachelor of Science in engineering discipline. Master of Science a plus.

· 10 + years industrial experience in medical device development and manufacturing

· Knowledge in Class II and Class III medical devices (quality systems as well as processes) from development to product introduction and device maintenance. Experience with electromechanical systems a plus.

· Extensive experience with device verification and validation

· Strong statistical foundation necessary to help define verification plans and document verification results

· Experience implementing and managing quality systems (design control, documentation control, supplier management, corrective and preventive action, etc.)

· Experience managing quality engineers or documentation control personnel a plus

· 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