Mechanical Engineering Team Leader

• Led and managed a team of 3-4 mechanical engineers focused on product development and testing.

• Set project goals, timelines, and deliverables, ensuring all milestones are achieved on time.

• Mentor and support team members to drive innovation, efficiency, and adherence to industry best practices.

• Oversee medical device mechanical design and development, ensuring that designs meet all performance, safety, and regulatory standards.

• Collaborate with cross-functional teams (electrical, software, quality, regulatory, etc.) to integrate mechanical designs into complete product systems.

• Ensure that all mechanical designs are feasible for manufacturing (DFM), cost-effective, and scalable for production.

• Analyze and document test data, ensuring all test results meet regulatory and safety standards

• Drive continuous improvement in testing methods, ensuring accurate and reliable data for decision-making.

• Support risk management activities, including the creation of FMEAs, risk analyses, and design verification/validation reports.

• Work closely with external vendors, suppliers, and contract manufacturers to ensure smooth product development and manufacturing processes.

Requirements:

• Bachelor's or Master's degree in Mechanical Engineering.

• 12+ years of experience in mechanical design and product development, with a focus on medical devices.

• 3+ years of experience in a leadership or team management role.

• Proven track record in mechanical testing, including design verification and validation.

• Proficiency in 3D CAD design (e.g., SolidWorks, AutoCAD).

• Excellent problem-solving skills and ability to work in a fast-paced, dynamic startup environment.

• Strong communication and interpersonal skills for effective team collaboration and stakeholder engagement.

• Experience with plastic molding and iteration in medical device development

• Knowledge of biocompatible materials and design for manufacturability (DFM).

• Familiarity with risk management processes

• Strong understanding of medical device regulations, including ISO 13485 and FDA requirements – Advantage.