Description

About the Role

Our client is seeking a dynamic and experienced Senior Mechanical Engineer to drive innovation in their product development efforts. In this pivotal role, you will collaborate with cross-functional teams to take projects from ideation through to commercialization, making a significant impact on healthcare solutions.

Your Key Responsibilities

• Lead the conceptualization, design, and development of new medical devices while adhering to Quality System Requirements.
• Act as the technical lead on multiple projects, managing development teams through various stages of product life cycles.
• Design and assemble prototype devices to assess their technical feasibility and performance.
• Convert user and patient needs into comprehensive design requirements, ensuring they meet verification and validation standards.
• Create robust test methods and develop design test fixtures for accurate evaluation of product specifications.
• Effectively communicate progress and project updates across departments to enhance collaboration.
• Tackle complex technical challenges by identifying and implementing innovative solutions.
• Engage with healthcare professionals to gather insights and ensure design considerations address real-world applications.
• Document protocols and generate reports on engineering studies using proven statistical methods.
• Collaborate with suppliers for component sourcing, fostering strong business relationships.
• Oversee verification and validation activities during regulatory approvals and design transfer phases.
• Contribute to the expansion of the product portfolio through design improvements and line extensions.
• Mentor junior engineers and peers to uplift the technical capabilities within the R&D department.

Requirements

Qualifications

• Bachelor's Degree in Engineering or a related field coupled with 5 years of relevant experience, or 8 years of technical experience in lieu of a degree.
• Strong analytical and problem-solving skills applied to product development.
• Excellent written and verbal communication capabilities for clear interaction with cross-functional teams.
• Proven ability to work independently and manage multiple projects efficiently.
• Strong interpersonal skills, allowing for effective collaboration within a team environment.
• Familiarity with statistical analysis techniques to support decision-making processes.
• Proficiency in software applications including Solidworks, spreadsheets, and databasing tools.
• Hands-on knowledge of lab equipment and practices, such as calipers, micrometers, and tensile testers.
• Understanding of US and international regulatory standards applicable to the medical device industry.

Preferred Skills

• Experience with materials and processes related to medical device manufacturing, such as extrusion, injection molding, and catheter fabrication.
• Knowledge in project management fundamentals, design controls, and quality systems.
• CAD design expertise, preferably using Solidworks.
• Familiarity with clinical applications and the ability to translate these into detailed product requirements.
• Demonstrated success in guiding products through development to successful market launch.

If you are ready to make a meaningful difference in the medical device industry and thrive on tackling challenges, we invite you to apply for this Senior Mechanical Engineer position!