Sr. Mechanical Engineer (Must Have Test Method Development, Verification, Medical Device)

Responsibilities

• Provide technical direction and oversight of V&V test method development activities. Define, plan and lead activities, including, test method & measurement system development and validation, fixture design and testing optimization in support of Design Verification.
• Participate in the planning and execution of technical project work. This will involve the application of engineering first principles and advanced engineering methods to gain deep understanding of the underlying technical issues, and to propose and implement robust solutions.
• Collaborate with Systems and Engineering teams to understand and derive specifications for a broad portfolio of MDS products.
• Create and document novel test methodologies and provide feedback and recommendations for product/design changes.
• Resolve technical problems. Identify or create solutions for technical problems using systematic problem-solving and statistical methodologies.
• Support project plan development and contribute to the development of the Design Verification strategy.
• Conduct and encourage frequent formal and informal communication with the team to ensure full engagement and efficient operation.
• Expected to mentor associates in related technical roles. Provide technical direction and frequent feedback.
• Developing personal skills, expertise, and competencies. Ensure that technical lessons are reviewed, learned, and disseminated.
• Ensure compliance with BD quality policies, procedures, and practices.
• Ensure compliance with all local, state, federal, and Client safety regulations, policies, and procedures.

Qualifications

• BS in Mechanical Engineering or related field
• 8+ years of relevant experience in mechanical engineering, with a focus on medical device testing and verification
• Experience with test method development, verification, and validation
• Strong knowledge of medical device regulatory requirements and standards
• Ability to develop and execute test plans and protocols
• Experience with statistical analysis and problem-solving techniques
• Excellent communication and collaboration skills