Principal Product Development Engineer

Job Description

General Purpose of Job:   

Responsible to lead in the design, development, integration, test and implementation to manufacturing of highly reliable, cost effective products and electro mechanical devices which can be used by our customers world-wide.  This principal engineer role maintains a global focus to ensure the product design and manufacturing processes are optimized for quality, reliability, Design For Manufacturability and low cost.  This principal engineer manages new product development projects and project teams, works with those team members to identify product design requirements, ensures the new product meets the product design requirements specification, verifies the product design by performing bench and field testing and performs a pre-production run to ensure the product is ready for production.

Essential Duties and Responsibilities: 

·         Manages the product development project by providing the following project planning – schedule with milestones and action items with due dates.

·         Manages the development of the product design requirement specification used to describe the product with design, performance and test requirements and defines regulatory and quality standards.

·         Uses engineering principles and techniques to research, design, analyze and test new product designs, technologies, materials and prototypes during product development.

·         Builds product bench top models for proof of principle.

·         Prepares a Design FMEA describing the product function and/or operation, listing the possible hazards and methods of risk reduction.

·         Defines the product design test requirements and specifications, prepares a test plan and provides test equipment for testing the new product design.

·         Provides the product design verification and test reports based on the test requirements and specifications listed in the product design requirement specification.

·         Performs a pre-production run working with manufacturing, quality and purchasing to ensure the product design meets the product design requirement specification and can be economically produced in production.

·         Researches design options and performs experiments to determine potential design feasibility or application. Responsible for design/development activities which may include leading, participating in, coordinating or supporting: concept, planning, design and execution stages.

·         Assists in the creation and release of Product Requirements, Design Specifications, and Design Descriptions for assigned designs, applicable standards and procedures. Responsible for recording and sharing technical knowledge gained with colleagues.

·         Reviews product documentation for accuracy including documentation intended for customer use.  

•   Evaluates product non-conformances and recommend design modifications.

•   Mentors other engineers and designers.

Secondary Duties and Responsibilities

·         Coordinates work with marketing, research, sales, quality and compliance departments to define the product design requirements and ensure these requirements are satisfied.

·         Works with outside vendors, suppliers, customers and governmental / regulatory agencies to define the product design requirements and ensure product compliance.

·         Coordinates work with the tool shop and outside vendors to develop and/or make tooling and prototypes for product development.

·         Coordinates work with marketing, research, sales, training departments and provide engineering support for field-testing and/or clinical studies.

·         Provides engineering expertise and/or support in the areas of tooling, prints, specifications, materials and vendor products throughout the organization.

·         Recommends methods, materials and provides drawings for product improvements based on manufacturing needs and capabilities.

Supervision

·         General Direction: Receives general guidance with respect to overall objectives and prioritization of work; operates within division or department policy guidelines using independent judgment in achieving assigned objectives.

·         Project Specific: Provides guidance to members of multi-disciplined product development teams as assigned.

Education and Experience

·         Bachelor’s Degree in Mechanical Engineering, Electrical Engineering or Biomedical Engineering, and minimum five years related experience and/or training or equivalent combination of education and experience developing electromechanical products.

·         Advanced degree preferred.

• Knowledge of electronics/electrical design.

• Experience with designing and prototyping basic circuitry.

• Experience with basic electronics equipment.

• Some knowledge of mechanical design a plus.
• 8-10 years experience managing cross-functional projects in regulated environments.

• Strong project management skill set required.
• Project management certification preferred.
• Six Sigma, Black Belt certification desired.

• Familiarity with essential requirements of the Medical Device Directive <x{(}>(MDD), ISO 13485, FDA design controls or similar regulatory environment.

 The ROHO Group is an Equal Opportunity Employer and we take seriously the responsibility of hiring a diverse and talented workforce.  

Additional Info

• Intended Start Date:
  Not Specified
• Employment Type:
  Full Time
• Compensation:
  Annual Salary
• Salary Range:
  

• Minimum Education:
  Unspecified
• Experience Level:
  7+ Years
• Travel Requirement:
  No travel

Company Info

• Name
  The Roho Group
• Company Website
  http://www.therohogroup.com/
• Industry
  Medical Devices
• Awards and Accolades
  

• Number of Employees
  Between 100 and 1000
• Type of Company
  Privately Held
• Stock Ticker
  

Contact Info

• Contact Name
  Visit website: http://www.pcrecruiter.net/pcrbin/regfirst.exe?uid=the%20roho%20group.therohogroup
• Phone Number
  Visit website
• Contact Email
  Visit website
• Contact Preference
  No Preference