The job is with a startup in the Boston area, and he's
asked me to not post the name of the company for confidentiality
reasons. If you're interested, please contact Platt Staunton at
434-972-7760 / platt_at_stauntonbiomedical.com.
-------------
TITLE: VP of Product Development and Manufacturing
REPORTS TO: President & CEO
PURPOSE, OBJECTIVES, FUNCTIONS:
The VP of Product Development and Manufacturing will lead the overall
product development and contract manufacturing efforts to support the
Company?s commercial and partnering objectives ? from prototype
design, and beta testing, through manufacturing transfer.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
? Integrate strategic platform and device needs relating to
development and production of prototypes and products
? Provide a technical vision for enabling and addressing new
opportunities by leveraging current platform capabilities
? Work closely with the engineering and strategic marketing teams to
translate platform innovation to commercial products that meet
customer requirements
? Implement a lean product development and design requirements
process, including VOC
? Ensure project accountability and adherence to schedules to
accelerate development
? Manage development risk and commercially oriented milestones
? Promote design for manufacturability and reliability
? Develop cost targets and production strategies to meet financial and
market demands
? Provide application support for partner evaluations of prototype
devices to ensure strategic success
? Work with QA/RA consultants to set-up and maintain systems and
procedures for full regulatory compliance, including CAPA and customer
support requirements
ADDITIONAL RESPONSIBLITIES:
? Organize and negotiate contracts with vendors and contract
manufacturers
? Provide strategic direction as a member of the senior management team
? Support regulatory process
? Support business development process
? Support corporate business strategy
EMPLOYMENT REQUIREMENTS:
? BS degree required; Masters in engineering preferred
? Minimum of 10 years experience in product development, engineering,
and manufacturing of therapeutic or diagnostic medical devices
? Direct experience transitioning pre-production technology to
high-volume manufacture, preferably with experience in use of Six
Sigma/Lean processes and tools
? Experience working with clinical trial results to integrate user
feedback into the product design specifications
? Demonstrated project management expertise and strong leadership
skills with an outstanding track record of setting and meeting
development deadlines
POSITION QUALIFICATIONS:
? Ability to manage complex projects and resolve complex issues
? Excellent supervisory, interpersonal, leadership, and project
management skills
? Ability and tenacity to move major initiatives forward through
focused effort and clear set of business goals
? Proficiency in integrating input from various functional areas and
customer feedback and bringing people together across boundaries to
achieve results
? Experience designing products for manufacturability
? Knowledge of medical device regulatory pathways and requirements
KEY PERSONAL CHARACTERISTICS:
? Excellent communication skills
? Strong leader
? A cheerleader for people and projects
? Can-do, enthusiastic style of leadership
? Hands-on, walk-around management style
? Production-minded and aggressive time-line oriented
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Potential applicants should communicate directly with the contact
listed in the posting. Please do not "reply" to the posting messages.
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Received on 2011-11-18 07:11:32