TITLE: MANAGER QUALITY ASSURANCE #308

REPORT TO: VP CLINICAL AND REGULATORY AFFAIRS
SALARY RANGE: 80-100k plus benefits/stock
LOCATION: SAN CLEMENTE, CA
Relocation, H1-B OKAY

COMPANY DESCRIPTION:

This is a development stage medical device company creating the next generation of Class III implantable electronic device utilizing state-of-the-art technologies with the current target of the development of a family of devices that will afford patient treatment that has been, until now, unattainable with the current therapeutic modalities and technologies.

POSITION SUMMARY:

The Manager of Quality Assurance plays a significant and strategic role in the success of the Company s ability to maintain the quality system requirements in compliance with national and international regulatory requirements.

• Represent the Quality perspective in Design Control and product development
• Responsible for the supervision, overall direction, and evaluation of the Quality Assurance Department
• Review change orders to determine if any submission is required
• Direct, manage and organize the Company's Quality activities for all current and future medical device products
• Manage, maintain and improve the quality system to support ISO certification and FDA site approval
• Manage the following functions: document control; internal audit program; complaint handling system; adverse event reporting (MDR/Vigilance)
• Maintain and develop the quality system, including creating and updating policies and procedures, as required according to regulatory requirements in cooperation with appropriate company members
• Manage Regulatory and Safety agency inspections
• Review product labeling and promotional materials to ensure compliance with regulatory requirements
• Maintain knowledge on changing worldwide regulatory and standards environment and interacts with US and Non-US distributors/contractors to keep updated on new requirements
• Encourage team participation in problem solving, system enhancements and in new product program
• Provides advice to management on quality issues, as required
• Performs other duties as the need arises or as directed by supervisor

POSITION REQUIREMENTS:

• Five to seven years industry experience in QA Management
• Class III device experience, preferably cardiology medical devices or equivalent combination of education experience in a directly related field
• Effective oral/written communications skills with preferences in 510(k), GMP, IDE, Clinical Studies, PMA QSR and ISO competency
• Ability to organize and prioritize work and to meet deadlines
• DOE experience
• Experience in statistical methods used in product development, operations and product reliability

EDUCATION:

Bachelor's degree in Science discipline or Engineering

 

TITLE: IT RECRUITER
LOCATION: SAN DIEGO, CA
SALARY: DOE

Are you an experienced, entrepreneurial IT recruiter seeking an opportunity to work hard - while still having fun in a dynamic industry? If so, this opportunity could be for you! Successful Start-up IT Recruiting Firm in San Diego is looking for a seasoned, results-driven IT recruiter to add to our dynamic and successful team. We specialize in staffing in the areas of Storage, Medical Device and Information Technology. We pride ourselves on providing our clients responsive staffing solutions to meet their human resources and project/contract needs. We continue to experience remarkable success in 2005 and are currently seeking an experienced Technical Recruiter to enhance our recruiting efforts.

POSITION SUMMARY:

This individual should have the ability to interface with high-level management up to CIO level in a fast-paced environment. Responsibilities include identifying, qualifying, matching, advising and managing IT candidates on exciting, opportunities with top companies in the market. Through a variety of recruiting resources, you will build a strong, extensive pipeline of quality candidates. You will also maintain/increase our presence in the local marketplace through participation in networking organizations and events.

POSITION REQUIREMENTS:

• Experience in Technical Recruiting
• Ability to multi-task on various positions
• Excellent interpersonal and communication skills
• Ability to work independently and set own priorities
  

TITLE: SENIOR MECHANICAL ENGINEER
SALARY: 80-100K
REPORTS TO: DIRECTOR ME
LOCATION: SAN CLEMENTE, CA
RELOCATION OKAY, NO H1-B

COMPANY DESCRIPTION:

This is a development stage medical device company creating the next generation of Class III implantable electronic device utilizing state-of-the-art technologies with the current target of the development of a family of devices that will afford patient treatment that has been, until now, unattainable with the current therapeutic modalities and technologies.

POSITION SUMMARY:

This position exists to develop the necessary mechanical component, sub-assembly, assembly and final products needed to produce the Company's new devices. This position participates as a member of the development engineering staff. Duties include development of proposed product requirements, implementation of design tasks, development and execution of design testing, supplier interface and multi-disciplinary project team participation.

DUTIES & RESPONSIBILITIES:

• As a member of the R&D technical staff, participate in the development and review of research and product development objectives
  
• Provide design and technical leadership in the functional area of expertise. Use computer aided design tools in the execution of design tasks including conceptual layouts, detailed design drawings, modeling, and design simulation
  
• Execute design and development tasks in support of project or research objectives
  Implement design requirements, including the development of technical specifications, performance specifications and product documentation in accordance with company procedures. Interface with internal customers and external suppliers in the execution of these tasks.
  
• Build and evaluate prototypes and design tools necessary to test and refine product designs
  
• Implement design verification and validation test requirements, including the development of test plan, protocols, and reports. Execute testing as required, including the design and development of test fixtures and resources necessary to perform these tasks.
  
• Participate on multi-disciplinary project teams, representing R&D function for team activities and decisions
  
• Ensure that all tasks are executed in accordance with Quality System procedures
  
• Comply with all design related standards as developed by external regulatory groups
  

In addition to the above, this position is presently responsible to:

• Perform as senior designer for product including all documentation
  
• Create all necessary mechanical component, sub-assembly, assembly and final product drawings and specifications. Generate change orders to existing documents. Review documentation generated by others relating to product responsibilities. Participate in design reviews.
  
• Verify all final design documentation, parts lists, and drawings with other engineers to insure completeness and accuracy
  
• Develop and maintain product version control using PDMworks for SolidWorks
  
• Perform dimensional, material property, and interference analysis as part of the design and development tasks as necessary
  
• Receive direct assignments from Director, Mechanical Engineering, or receive assignment requests from other groups in the company. Maintain responsibility for ensuring that priorities as set by supervisor are followed.
  

POSITION REQUIREMENTS:

• Minimum - 8 years industry experience in a medical device environment
  
• Mechanical aptitude and an understanding of Mechanical Engineering principles
  
• Working knowledge of current CAD tools needed; experience with SolidWorks a plus
  
• Experience with FDA and ISO design control procedures and specifications
  
• Experienced in the use of analytical tools and methods including statistics, DOE, and computer/software packages
  
• Experience with Finite Element Analysis (FEA) highly desirable
  
• Good teamwork and interpersonal skills
  

EDUCATION:

Bachelors of Science in Mechanical Engineering or Life Sciences, minimum