Director of Engineering and Product Development Process

Description

The Director of Engineering and Product Development Process is responsible for planning and directing all aspects of engineering activities and projects within the engineering team and for companywide adherence to the product development process. This position is responsible for the electrical, mechanical, and systems engineering teams ensuring that the work delivered is of high quality, that proper processes are in place, and that the team is properly staffed to execute on project work. The Director of Engineering and Product Development Process, working with the team leads, will determine the scope of work required from the engineering teams providing resource estimates used for project planning and while identifying and filling any gaps.

The Director of Engineering and Product Development Process owns the Product Development Process, a QMS Procedure, used to develop new products. This broad responsibility spans across the entire company to ensure that development processes are correctly designed, implemented and followed by everyone involved development projects.

Responsibilities

  • Lead and direct all aspects of engineering work needed to complete projects on the product roadmap.
  • Own and maintain the Product Development Process (QMS)
  • Ensure that Product Development Process is followed on every project across all organizations (R&D, Product Development, Product Management, Marketing, Manufacturing)
  • Establish engineering policies and procedures for the team following industry best practices
  • Ensure a high degree of quality for design control specifications (user requirements, design inputs, system requirements, sub system requirements, design outputs) and that they meet the business needs of the organization.
  • Ensure that engineering team is properly staffed for planned project work
  • A key contributor to the development of project plans and budgets to achieve stated goals and objectives.

Required Qualifications

  • Strong leadership ability, team builder, team player, and decision maker.
  • 10+ years’ experience in the scientific instrument or medical device industry.
  • 5+ years’ experience in an engineering leadership role in the scientific instrument or medical device industry.
  • Extremely process driven with demonstrated experience creating and implementing product development processes.
  • Track record of managing the development of products from beginning to release.
  • Strong ability to balance the technical and business requirements of projects.
  • Bachelor of Science Degree. Engineering preferred
  • Ability to communicate effectively to top management and C-suite.
  • Occasional travel as needed.

Prefered Qualifications

  • Extensive project management experience
  • Strong understanding of instrumentation development and regulatory/safety requirements. Medical device regulatory and quality control experience a plus.
  • Thorough knowledge of the business and the environment in which the company operates.
  • Advanced degree in Engineering, Science, or Management a Plus

Cultural, Behavioral and General Characteristics

  • Integrity
  • Collaborative
  • Independent and self-starter
  • Work standards/high work ethic – initiative and drive
  • Innovativeness & creativity
  • Self-sufficient, self-driven, self-motivated (work with minimal supervision): figure it out
  • Adaptability
  • Ability to quickly learn SLIM technology and apply it
  • Ability to think through complex issues and solve problems
  • Desire to share information and support a transparent culture
  • Technical translation

Key Relationships

  • Internal Interactions:
    • Engineering Team
    • Software Development
    • Project Management
    • Product Management
    • Commercial Operations
    • CEO and Strategic Leadership Team
  • External Interactions:
    • Design and Development Contractors
    • Mass Spec Vendors

Cultural, Behavioral and General Characteristics

  • Outstanding people skills; confident, great communicator, honest, and sincere
  • Must be a dynamic personality and willing to work within a collaborative team environment
  • Energetic, proactive self-starter who enjoys challenges and variety
  • Integrity
  • Independent and self-starter
  • Work standards/high work ethic – initiative and drive
  • Innovativeness & creativity
  • Self-sufficient, self-driven, self-motivated (work with minimal supervision): figure it out
  • Adaptability
  • Ability to think through complex issues and solve problems
  • Desire to share information and support a transparent culture
  • Technical translation

If interested, please send a cover letter and resume to careers@mobilionsystems.com.

Job Type: Full Time
Job Location: Philadelphia Area

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