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<title>Medicaldevicestar.com: Medical Device Jobs </title>
<description>Medical Device Jobs Made Simple</description>
<link>http://www.medicaldevicestar.com</link>
<pubDate>Thu, 01 Jul 2010 13:30:47 MST</pubDate>
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<guid isPermaLink="true">http://www.medicaldevicestar.com/job/3662</guid>
<title>Product Marketing Manager - Medical Device</title>
<description>Location: Indianapolis, IN. <![CDATA[DUTIES
* Primarily responsible for strategic planning, product planning, product marketing and establishing pricing for molded products.
* Managing products throughout the production cycle, gathering and prioritizing technical product and customer requirements working closely with engineering.
* Secure, review and coordinate tooling, molding and design requirements.
* Manage product planning and product development activities to drive increased market penetration and business results. 
* Develop marketing for the core positioning and messaging for the products.
* Set pricing to meet revenue and profitability goals. 
* Brief and train the sales force and perform product demos to customers; develop sales tools and collateral.
* Lead the development of annual sales revenue forecasts in regards to marketing objectives. 
* Supports and participates in the Quality System, Revenue Forecasting and Management reviews.

REQUIREMENTS
* Minimum of BS or BA in Engineering or Marketing. 
* Minimum of 3-10 years of Technical Marketing experience with molded product lines and markets.
* Must have industry marketing experience in regards to materials, products, cost factors, pricing, strategic analysis and industry competition.
* Experienced business development & revenue generation with new markets.
* Experience with tooling, molds and product design requirements.
* Leadership and teamwork skills with the ability to influence and bring cross functional teams to mutually beneficial solutions without formal authority.
* Technical and/or engineering background, with experience in rubber or plastic processing.
* Good oral and written communication skills with the ability to effectively communicate with all levels of the organization.
* Must have the ability to manage and prioritize multiple projects at once.]]></description>
<link>http://www.medicaldevicestar.com/job/3662</link>
<pubDate>Tue, 22 Jun 2010 13:36:31 MST</pubDate>
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<guid isPermaLink="true">http://www.medicaldevicestar.com/job/3661</guid>
<title>Medical Device Project Manager</title>
<description>Location: Santa Barbara, CA. <![CDATA[MAIN DUTIES
Project & Quotation Management
* As the Advanced Product Quality Planning (APQP) champion, this position schedules and coordinates new prototype and production projects, (correspondence, preparation, and follow-up).
* Works Manufacturing Engineering and reviews proposed costs, recommends pricing to the Business Unit Manager and/or Sales and Marketing Managers and finalizes quotes and projects as directed.
* Provides information for survey and capabilities questionnaires and supports audits.  
* Review completed written project items that have directly contributed to problem resolution in dealing with customer relations, cost, pricing or a factor that contributes to our ability to compete.  
* Quarterly review of business unit performance and monthly review of assigned high visibility projects.
* Able to develop and implement human resource plans with functional/departmental managers to ensure that the right amount of resources are utilized at each project phase to keep the project on schedule and establish a stable base for ongoing manufacturing. 
* Leads project team in all phases of the program in accordance with QSR, GMP requirements. 

REQUIREMENTS
* 4 year Engineering degree
* 5-12 years of medical/pharma industry product experience
* Project management experience including prototyping, design, process and manufacturing.
* Experience managing project requirements, project costing and project timelines.
* Injection molding experience-preferably with silicone molding.
* Product assembly experience from concept to completion.]]></description>
<link>http://www.medicaldevicestar.com/job/3661</link>
<pubDate>Tue, 22 Jun 2010 13:33:05 MST</pubDate>
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<guid isPermaLink="true">http://www.medicaldevicestar.com/job/3660</guid>
<title>Manager of Manufacturing Engineering </title>
<description>Location: Santa Barbara, CA. <![CDATA[JOB DUTIES AND RESPONSIBILITIES
* Manage development of tooling and processing solutions to meet the stringent demands of waste-less liquid injection molding.  (LIM). 
* Coordinate/manage tool designers, programmers, and engineers to support LIM tooling. 
* Coordinate/standardize system and procedural implementation for Engineering Team.
* Coordinate/manage production support through documented process set-ups, monitoring, and adjustments. Oversee Program Management and Process improvement & optimization.
* Help troubleshoot equipment, tooling, and materials for samples and production. 
* Supports new product quote activities through process description, part costing, packaging, process FMEA and control plans.
* Participates in the financial justification, selection, purchase, installation, and start-up of new equipment projects.
* Communicate with customers and suppliers as required.
* Focuses on reducing costs of existing product through efficiency, scrap reduction, etc.
* Performs necessary functions to adhere to FDA & ISO13485 standards.   

QUALIFICATIONS
* B.S. Mechanical Engineering / Chemical Engineering or related technical degree. 
* 5-10 years hands-on liquid rubber/silicone/plastic injection molding processing and tooling experience. Extruded medical products processing desired.
* Strong Product Engineering, Tooling, Process experience for molded medical products.
* Experienced with FDA and Cleanroom guidelines.
* Hands on Engineering supervision and/or team leadership experience. 
* Delegating, leading coaching, mentoring, supporting & developing team members.
* Knowledgeable in Lean/Kaizen Systems and Six Sigma methodology.  
* CAD and programming knowledge.
* Strong computer skills: Word, Excel & MS Project.
(Must have all requirements stated above)  ]]></description>
<link>http://www.medicaldevicestar.com/job/3660</link>
<pubDate>Tue, 22 Jun 2010 13:31:14 MST</pubDate>
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<guid isPermaLink="true">http://www.medicaldevicestar.com/job/3659</guid>
<title>Manager of Compliance/Regulatory</title>
<description>Location: Santa Barbara, CA. <![CDATA[DUTIES 
* Responsibility as a management representative will include liaison with external parties on matters relating to the quality management system.(In house, vendors & customers)
* Develop and implement internal Quality/Regulatory documentation processes to meet FDA & ISO and other regulatory compliance requirements.
* Develop and implement a cross functional internal audit program/team to ensure all regulatory requirements are met.
* Lead and provide expert advice in the areas of compliance QSR, ISO13485. 
* Monitor and report on all regulatory compliance activities within the business units. 
* Lead assigned due diligence and new business integration activities as required. 
* Develop QMS initiatives to drive simplification and standardization throughout the organization.
* Manage overall coaching, training, development and succession plans for the regulatory and quality assurance teams.

QUALIFICATIONS 
* BS in Science or Engineering and Lead Auditor certification or ASQ Professional Certification
* 5 -8 years minimum manufacturing background in medical device or pharmaceuticals.
* 5 -8 years management experience in Compliance & Regulatory with FDA and other regulatory bodies. 
* Ability to effectively interface interdepartmentally.
* Perseverance in investigating alleged non-compliance.
* Effective organizational, technical and problem solving skills.
* Computer skills in word processing, spreadsheets, and databases highly desirable. Proven success with FDA and Notified Body interface.
* Understanding of the internal Quality Management System, United States Quality System Regulation (21 CFR 820), the Medical Device Directives, ISO 13485, CAN/CSA–ISO 13485 and all other applicable medical device regulations. 
* Experience and demonstrated understanding of quality assurance in a medical device manufacturing and sales environment.
* Experience with silicone and molding or extrusion processing highly advantageous.
* Effective oral, written, documentation and presentation skills.]]></description>
<link>http://www.medicaldevicestar.com/job/3659</link>
<pubDate>Tue, 22 Jun 2010 13:29:49 MST</pubDate>
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