Principal Mechanical Design Eng with medical devices Exp.

The Principal Engineer will serve as a key member in the Pump Hardware 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 and project leadership, with an emphasis on consumer plastic component design 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. Past engineering experience developing, delivering, deploying and maintaining medical devices is required for this position. Past experience in plastic part design and/or mold design is required for this position

Technical competencies

• In depth knowledge and experience in designing plastic parts for injection molding.
• In depth knowledge and experience of plastic material properties and plastic molding analysis software such as Moldflow
• In depth knowledge and experience with assembly methods for plastic parts.
• Possesses a working knowledge of regulatory agency requirements.
• Independently reviews and analyzes new designs for DFMA/DFS 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 develop complex designs to the point of manufacture and release to production.
• Advanced understanding of analysis tools, methods, and statistical techniques.
• Ability to work with manufacturing automation to ensure successful six sigma design and processes
• Strong ability to work with vendors as well as contract design and manufacturing companies.
• Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment. May provide guidance to lower level personnel.
• Represents the organization as the prime technical contact on contracts and projects.
• 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.

Basic Qualifications

• 8+ years experience in designing mechanical components and systems.
• 5+ years experience in designing complex plastic injection components and the analysis of designs using simulation software.
• 3+ years experience working with contract design and manufacturing companies
• 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.
• Strong familiarity with mold construction, design, and industry standards for mold processes and equipment
• MSME from an accredited college or university
• Lean product development experience. • DRM (Design for Reliability and Manufacturability) experience
• 5 yrs+ in Medical products environment or a regulated industry