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Product Development Engineer - Mid

Waltham, MA 02452

Posted: 04/01/2023 Job Number: 31976

Job Description


PURPOSE

The Product Development Engineer is responsible for providing technical support to high impact Research & Development initiatives, including new opportunity identification, technology development, product development, and line extensions

RESPONSIBILITIES
  • Provides technical support to product development initiatives within new product development and sustaining engineering portfolios
  • Effectively operates on project teams in the development of products and technologies from concept to commercialization while adhering to medical device design         controls/regulatory requirements
  • Defines product specifications, design inputs, product design, verification testing, and supporting design validation studies.
  • Provides technical and project support to cross-functional teams on design, development, and research projects
  • Performs engineering analyses to support new and existing designs
  • Fabricates prototypes with assistance from junior staff, the technical support team, and internal and external suppliers
  • Works with internal and external manufacturing partners to ensure producible designs
  • Contributes to company Intellectual Property Portfolio
  • Effectively communicate activity status, issues, and mitigation plans with key stakeholders
  • Other duties as required

 
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
  • Possesses sufficient engineering acumen required to support technical activities  such as executing technical activities such as running engineering tests, coordinating,  and  generating testing protocols.
  • Knowledge of cGMPs and FDA/CE Mark regulatory requirements
  • Knowledge of Microsoft Office’ s suite of products
  • Excellent communication skills, both written and verbal.
  • Ability to support technical assessment(s), generating, and documenting test plans and reports
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients
  • Ability to manage multiple priorities simultaneously

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
  • Bachelor's degree in Engineering or related field; or equivalent combination of education, training, and experience
  • 3+ years of experience

 

Meet Your Recruiter

Fran Hardy

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