R&D, Mechanical Engineer

About the role

Join *** Urology in the fast-paced world of acquisitions and integrations! The Urology Research & Development (R&D) organization is seeking a highly skilled and motivated R&D Engineer to join our team. In this role, you will provide support to assess design effectiveness of medical devices and evaluate compliance with *** requirements and international standards as part of an acquisition and integration of a third-party company. This role would be responsible for assessing the acquired company's Design History File (DHF) and updating associated design documentation and design outputs to address any gaps against the *** Quality Management System.

Responsibilities

• Provide design solutions and technical support under guidance of subject matter experts.
• Utilize background in mechanical design, test method design and validation, verification testing, and statistical analysis.
• Test products for feasibility, develop test methods, and perform formal design verification testing.
• Provide input to project goals and progress and recommend appropriate revisions.
• Communicate progress, risks, and trade-offs of technical deliverables to project leadership and recommend revisions as needed.
• Complete engineering work in one or more of the following: technology development or remediation, product design refinement, test of materials, preparation of specifications, process study, and report preparation.
• Assess the feasibility and soundness of alternative engineering processes, products, or equipment.
• Complete clear and concise engineering documentation.
• Demonstrate Technology Development and Product Development system knowledge through delivery of high-quality, high-impact deliverables.

Required Qualifications

• Bachelor's degree or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field.
• 2+ years of engineering or related experience with bachelor's degree; with MS degree, over 1 year of experience.
• Strong mechanical and problem-solving skills and attention to detail.
• Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources.
• Strong written and verbal communication, judgment, decision-making, collaboration, and critical thinking skills.
• Personal drive, individual accountability, and a strong bias for action.
• 10% travel.

Preferred Qualifications

• Experience with integrations and working with cross-functional teams.
• Test method development and validation experience.
• Experience in Minitab.
• Experience in single-use device design verification testing and data analysis.
• Ability to build strong relationships across the organization and with external stakeholders.