The Principal Engineer will serve as a key member in the Consumables R&D group and have the experience and drive to manage and aid in the engineering, development, and release of medical device products. This position will provide technical leadership, coaching, and direction for other engineering personnel to ensure our customer needs, quality and productivity goals are met.
This position is responsible for all activities across the product development lifecycle. They should feel comfortable dealing with ambiguity, and confident about being able to apply engineering experience and principles to make pragmatic choices about design, manufacturing, and quality system processes. They should have excellent communication and collaboration skills. Past engineering experience developing, delivering, deploying and maintaining medical devices is required for this position.
Position Responsibilities: Technical competencies:
Possesses a working knowledge of regulatory agency requirements.
Independently reviews and analyzes new designs for DFMA/Client and provides feedback to design teams.
Demonstrates working knowledge of risk management tools, and works within a team to analyze and mitigate project risks.
Able to manipulate disparate data and draw reasonable conclusions.
Able to discern gaps in information and work with others to address them.
Comfortable probing designs to ensure it is appropriate for all expected uses.
Able to develop complex designs to the point of manufacture and release to production.
Evaluates and applies design trade-offs and constraints for design optimization.
Skilled in the use of advanced analysis tools, methods, and statistical techniques.
Is able to prepare and present comprehensive design reviews.
Able to identify gaps in requirements as a whole. Understands value of use cases.
Ability to define integration points, objectives of integration points and create plans and protocols to successfully create integration.
Ability to work with multifunctional teams to assure entry into integration is clearly defined to make integration successful.
Strong ability to work with vendors as well as contract design and manufacturing companies.
Applies extensive technical expertise and has full knowledge of other related disciplines.
Develops technical solutions to complex problems that require the regular use of ingenuity and creativity
Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long-term perspective, for desired results. May provide guidance to lower level personnel.
Represents the organization as the prime technical contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations.
Have excellent interpersonal, written and verbal communication skills; Individual must communicate well with all levels of management and employees as well as customers and external collaborators
Participate or lead special project teams and individual employees continuously. Schedule and coordinate project meetings. Interface with cross-functional groups, aligning priorities to achieve a common end goal.
Knowledgeable in current and possible future policies, practices, trends, technology and information affecting own geographical area.
Communicates in ways that help people understand change and what needs to be done to execute it well.
Deals constructively with mistakes and setbacks.
Carefully weighs the pros/cons and makes appropriate decisions based calculated risk assessment.
Explains own decisions and decision- making process while being open to feedback.
Evaluates new information with existing information/ paradigms to create new and innovative ideas/ways of doing things.
Actively pursues development opportunities. Views mistakes as learning opportunities. Understands importance of balancing own development with competencies required of the organization/role.
Appropriately involves others in decisions and plans that affect them.
Credits others for their accomplishments.
Clearly expresses ideas and concepts in writing
Exhibits appropriate nonverbal behavior to show receptivity to others' spoken messages.
Prepares and delivers clear, well-organized presentations.
Bachelors degree in Mechanical Engineering or Bachelors degree in Plastics Engineering from an accredited college or university
Strong knowledge of thermo plastic materials and specifications (ABS, PVC, Polypropylenes,etc)
Strong background in design of injection molded parts and assemblies and their associated manufacturing processes.
7+ years experience in designing mechanical components and systems.
3+ years experience working with contract design and manufacturing companies
MSME from an accredited college or university
Lean product development experience.
DRM (Design for Reliability and Manufacturability) experience
2 yrs+ in Medical products environment or a regulated industry
Physical Job Requirements:
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
Must occasionally lift and/or move up to 7 kilograms.
While performing the duties of this job, the employee is regularly required to talk, hear, and work with a computer.
Frequently required to sit, stand, walk, and handle objects, tools, or controls.
This job description is intended to describe the general nature and level of work being performed. It s not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees
Artech Information Systems LLC - 19 months ago
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