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WW manufacturer of devices is seeking a ME in R&D who has a background in
New Product Development
CHARACTERISTICS OF THE CLASS: Under general supervision, serves on a team or
may lead a small team responsible for designing and developing precision
electro-mechanical products for use in the dental market to include new
products as well as line extensions; performs related duties as required.
ESSENTIAL DUTIES:
Leads small multifunctional teams in the development of new products and/or
the design and development of an important area of a major new product.
Ensures effective communication within the team and between the team and the
rest of the organization. Actively manages the time line using project
management techniques and ensures there is clarity and focus on the critical
path and that appropriate contingency plans are in place.
Leads technical teams developing line extensions or may participate on a
technical team developing next generation products. . Ensures that product
requirements are clearly defined and met and that design control is
documented in accordance with Company and regulatory requirements. .
Interacts with internal and external customers to understand and define
design requirements.
Utilizes sound engineering practices and principles as well as state of the
art technology and analysis tools to resolve technical challenges. Maintains
knowledge of current developments in technical literature, both in
engineering and dentistry. Resolves complex engineering problems in a timely
manor with little direction from manager.
May directly supervise several technicians. May be responsible for:
staffing, performance management, professional development and coaching.
Develops clear objectives and measurements and hold employees accountable
for meeting their objectives. Ensures compliance to Company and regulatory
policies, programs, and procedures. .
RELATED DUTIES: Keeps abreast of changing technologies in order to apply
creative solutions to problems. Works with the Engineering Manager to
forecast engineering and capital needs throughout new product development.
Maintains engineering records and prepares reports. May be responsible for
reviewing, documenting, logging, maintaining and/or initiating the
investigation of product complaints.
MINIMUM QUALIFICATIONS:
Training and Experience:
Bachelor�s degree in mechanical engineering, supplemented by three years
of applicable engineering experience in a product development
environment; or an equivalent combination of training and experience is
required.
Knowledge, Abilities and Skills:
Comprehensive knowledge of mechanical engineering technologies. Thorough
knowledge of Good Manufacturing Practices (GMP). Knowledge of FDA, OSHA,
European Medical Device Directive, ISO 13485 requirements and
regulations as they apply to this position. Working knowledge of
engineering materials and fabrication processes.
Ability to innovate by understanding customers� needs and identifying
technical solutions to problems. Ability to communicate effectively,
both verbally and in writing. Ability to lead a group in
resolving/overcoming technical challenges. Ability to exercise good
judgment in evaluating situations. Ability to work well under pressure
and to meet deadlines.
Excellent analytical and problem solving skills. Strong initiative and
leadership skills.
PHYSICAL REQUIREMENTS:
Able to stand, walk, bend, reach, and lift up to 30 pounds occasionally.
Able to communicate well, both verbally and in writing. Able to use a
personal computer and appropriate software.
Working Conditions:
Office and manufacturing plant environment with some variations in
temperature, fumes, noise, dust and atmospheric conditions. Travel
approximately 15%.
TRNG.002-F01 Rev E FORM#033-176P1
Mid Atlantic State with a WW manufacturer of Medical Devices
Relocation
Excellent Benefits
Salary$ 65- 85M
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