Senior Product Development Engineer

RESPONSIBILITIES:

• The Senior Product Development Engineer will design new components and devices while making improvements and design changes to existing components and devices.
• Ensure regulatory requirements are met and designed devices meet intended use requirements.
• Drive innovation to improve device outcome by guiding the project team.
• Leads and oversees large projects involving of phases of design and development.
• Coordinates Commercial Release project activities while ensuring expectations are met.
• Develop product requirements based on the applicable standards.
• Create validation and verification plans to meet test methods and protocols.
• Ensure all aspects of product design including variability, usability, scalability and manufacturability.
• Uphold company vision and values.
• Adhere to all safety absolutes and guidelines.

QUALIFICATIONS:

• Bachelor s degree in Engineering or a related field with equivalent experience.
• Prefer Master s degree in Engineering.
• The Sr Product Development Engineer will have medical device Industry experience of 7 years.
• Proficient in Microsoft Project, Excel, Work, Outlook and PowerPoint.
• Experience in developing project plans on full scale.
• Vast knowledge and understanding of ISO 13485 design control requirements.
• Ability to oversee revenue recognition and budget accountability.
• Preferred Knowledge of applicable standards for EtO sterilization (e.g. ANSI/AAMI/ISO 11135-1, ANSI/AAMI/ISO 11135-2)

BENEFITS:

• Direct Hire
• Paid Time Off
• Medical Insurance
• Vision Insurance
• Dental Insurance

Ask for: Julie Roberts

Ajulia Executive Search is a New Jersey based Executive Search Firm specializing in retained searches in multiple sectors, including Manufacturing, Finance, IT, Legal, and Pharmaceutical. We have a nationwide client base and offer services in temporary and direct hire placements.