Product Development Engineer 2

Role Overview:

In this role, you will design and execute projects, providing imaginative and thorough solutions to a wide range of assignments with an emphasis on biologics, biomaterials, and tissue product development. The successful candidate will have the opportunity to lead product development from the feasibility phase to product commercialization.

Responsibilities:

• Contribute new ideas/concepts and present cogent research results to internal and external professionals.
• Lead or support the design and characterization studies of regenerative medical devices in accordance with industry standards.
• Maintain a level of scientific knowledge in assigned area; perform scientific literature searches and evaluations as required and understand/comply with accepted laboratory and safety procedures.
• Understand and apply current technology and evaluate related investigations and information from the literature.
• Document scientific evidence following documentation requirements.
• Present results of scientific research, development/assessment and handover activities, and be responsible for projects involving considerable research.
• Work closely with the team to ensure the efficient progress of projects.
• Creative for new technology development using internal resources for product development activities.

Location:

Columbia, MD

Education:

• Bachelor of Science required (Biomaterials, Biomedical Engineering, or material science and engineering)
• Postgraduate degree in same disciplines preferred

Experience:

• 4 years' experience in biomaterials, biomedical engineering or related engineering experience required
• Minimum of 2 years' experience in product development within Medical devices or Biotech preferred

Competences:

• Experience in FDA regulated environment strongly preferred.
• Experience with design control and FDA 510k submission strongly preferred.
• Experience with Product design, process design, design verification, and validation.
• Experience with Medical Device industry standards preferred, such as sterilization validation, packaging validation, human factors etc.
• Excellent communication skills in order to interface with cross functional team members including Manufacturing, Engineering, Regulatory, Quality, Project Management and Marketing.

Travel Requirements:

Up to 5%

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.