Principal Mechanical Engineer

The Opportunity:

This position will be on-site at our Alameda, California location. Recognized expert with broad expertise in mechanical design engineering, new product development and design transfer with responsibility for resolving significant technical issues as well as providing direction for new technology and product development activities with a broad impact to the company goals. Works on the design and development of significant new products.  Key decision-maker in identifying areas of technology for potential implementation into our products and processes. Leads the technical supervision and project management of complex engineering projects and activities. Develops networks involving cross-functional and cross-departmental groups (Operations, Marketing, Quality, Regulatory) as well as communication to senior and executive management.

What you will do:

• Specify, design, verify and validate new mechanical designs, in accordance with applicable medical regulatory standards.
• Support high-level technical investigation of manufacturing line issues.
• Responsible for the development of technical project plans and schedules covering all engineering activities, meeting all design control and product development SOP requirements
• Works in the development and management of resource plans, budgets, schedules, etc.
• Lead the development of product specifications, FMEAs, DOEs, verification and validation protocols and plans.
• Responsible for managing resources, the creation of project schedules and setting and maintaining budgets.
• Communicates effectively and participates in cross functional development teams.
• Participates in technical design reviews of mechanical design, hardware, PCBA interface, mechanical assemblies, production processes, product design and requirements documents.
• Writing, submittal, and approval of Engineering Changes, as required.
• May review and approve ECs.
• Act as independent reviewer on programs in which not directly involved.
• Responsible for utilizing and maintaining the effectiveness of the quality system.
• Ensure that product designs, components and materials meet all applicable standards
• Responsible for compliance with applicable Corporate and Divisional Policies.
• Development and execution of new medical devices, processes, equipment, materials, verification and validation Implement approved Design Control procedures for product development in accordance with FDA guidelines.
• Provide mentoring, technical guidance for mechanical engineering team.

Required Qualifications:

• Bachelor’s degree in mechanical engineering or equivalent engineering or scientific discipline.  Master’s degree is preferred.
• Minimum 10 years related experience in engineering.
• Strong technical experience in mechanical engineering, with excellent written and verbal communication skills. 
• Excellent knowledge of general engineering principles.  Extensive knowledge of regulations for medical device development (ISO15197, ISO134851, ISO13485, FDA) desired.
• Extensive understanding of processes and materials used in the development and manufacturing of medical devices is ideal. 

Preferred Qualifications:

• Extensive experience in all of the following: Performing complex engineering calculations and relating results to controlled tests, including statistical analysis, tolerance analysis.
• Working in a development environment with an emphasis on medical device product development.
• Writing product requirements and design specifications.
• Supporting equipment/facility/process commissioning and validation required.
• Working on a development team with an emphasis on minimizing time to market.
• Design for manufacture of low-cost, high-volume disposable products. 
• Extensive knowledge and understanding of GxP, ISO and medical device regulations and the development and implementation of new products in a regulated environment desired. 
• Extensive experience working in cross-functional team environments is required.