Title: Mechanical Project Engineer Exempt? Yes No

Department: Development Prepared By: Alex Schwarz

Reports To: VP Development Date: 02/01/08

Summary:

Support development and initial manufacturing of innovative device products, including the design of administrations devices and the design of new polymeric devices, for various new product development projects. Support programs that involve multiple interfaces internal and external to the company. Work with project teams and manage the required documentation, including but not limited to, project planning, risk management, design reviews and design history file creation and maintenance. Fully document the designs through verification/validation and ultimately product release. Identify and qualify key external sources to assist with the development, testing and manufacturing, as required.

Responsibilities and Essential Duties:

• Interface with Operations, Clinical Research, and Regulatory groups to assist with developing user requirements and evaluate designs
• Work within the design control process for a given program, providing technical and administrative oversight, complying with current GMPs, FDA’s QSr, MDD, and other regulatory standards/guidelines as well as Aeris’ SOPs
• Generate protocols utilizing appropriate statistical techniques and manage the execution of such related to design verification/validation and test method validation, as required
• Develop initial manufacturing instructions, hazard analysis (according to ISO 14971 and design/process FMEAs) and essential requirements checklists, product specifications, drawings, manufacturing instructions, product labeling, costing, and bills of material
• Create final product documentation, system specifications, etc.
• Perform data analysis and write summary reports
• Develop and validate user instructions, as required

Requirements:

• BS degree in Mechanical Engineering with minimum of (5) years direct development/manufacturing experience in a GMP medical device company
• Experience working with polymers, preferably hydrogels, plastics, extrusion and injection molding including robust manufacturing processes/capabilities
• Working knowledge of QSr, ISO 13485:2003 and other EU regulatory standards
• Proficient in technical writing and statistical techniques/analysis
• Ability to manage multiple priorities with excellent time management skills required
• Experience working on product development teams in a design capacity in compliance with design control requirements.
• Strong computer skills with a working knowledge of Microsoft Word, Excel, PowerPoint, Project and Visio.
• Must be well organized and possess keen presentation skills.

• Excellent written and oral communication skills
• Able to work in a fast-paced environment and comfortable working independently and in a team environment
• Must be self motivated with able to initiate and follow-through on assignments

Preferred Experience/Skills/Certificates:

• Medical device experience working with delivery systems strongly desired
• Hand-on experience with hydrogel systems strongly desired
• Project management certification