PURPOSE OF JOB: The Senior Engineer is responsible for the
design, development, execution and implementation of cardiac
implantable medical devices in support of the Company's Research and
Development efforts.
TYPICAL RESPONSIBILITIES/DUTIES
1) Full cycle product design and development to include prototype
manufacture, device testing, pre-clinical animal studies,
characterization, analysis and reporting.
2) Problem-solving based on clinical feedback and/or related to
clinical field issues.
3) Work as part of product development team to define, develop,
verify, validate, and support products in a clinical trial.
4) Work with Manufacturing with process development and
coordinating design transfer and release of new products.
5) Manage design and development projects according to established
Design Control procedures.
6) Present information cross-functionally as well as intra-departmentally.
7) Work with outside vendors and consultants.
8) Execute work in accordance with applicable regulatory requirements.
9) Train, develop and lead technicians in functional areas.
10) Interface with other functional areas of the business:
clinical, quality assurance, regulatory assurance and engineering as
needed to ensure effective collaboration and teamwork.
QUALIFICATIONS, DESIRED SKILLS & EXPERIENCE:
1) Experience in medical cardiac implant design and development,
manufacturing processes and regulatory requirements.
2) Knowledge of implantable materials; nitinol experience a plus.
3) Knowledge of fatigue properties and in vitro test methods of
implantable metal materials.
4) 4+ years experience in medical device development and FDA
regulatory processes with solid knowledge of design control requirements.
5) Bachelors of Science degree in Mechanical or Bioengineering
required. Masters of Science degree in Engineering Sciences preferred.
6) Proficient in SolidWorks.
7) Working knowledge of regulatory, clinical and quality system
requirements.
8) Knowledgeable and experienced in processes such as machining,
extruding, injection molding.
9) Excellent interpersonal communication and time management
skills. A self-starter, requires little supervision.
10) Demonstrated ability to manage and prioritize multiple
tasks/projects with a strong problem solving ability.
Paul Sanderson
Sanderson Mcleod
<mailto:paul_at_sandersonmcleod.com>paul_at_sandersonmcleod.com
www.sandersonmcleod.com
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Received on 2011-12-16 10:58:35