Electromechanical Engineering Lead

This role is part of the Company's Research & Development Integrated Systems Department. This role plays a vital role in crafting the future of new and existing medical devices, fostering innovation in the med tech industry. This Design Engineering Lead role will drive the development of reusable/capital electro-mechanical medical devices from concept through design freeze. This role involves leading a multidisciplinary team of engineers and designers, collaborating closely with internal stakeholders and external partners, and managing all phases of New Product Development (NPD). Specific responsibilities include:

• Designing electro-mechanical reusable/capital medical devices from concept through design freeze.
• Creating comprehensive design documentation.
• Overseeing testing in both bench and clinical environments.
• Ensuring seamless execution through vendor and supplier coordination.
• Leading a team of engineers and designers.
• Engaging effectively with internal and external clients such as sales, marketing, regulatory, quality assurance, manufacturing, procurement, and engineering teams.
• Traveling domestically and internationally to support New Product Development (NPD) efforts.
• Creating design documentation such as user needs assessments, design specifications, test plans, risk analysis reports, and technical files.
• Performing testing and evaluating developments at the bench level and in clinical environments.
• Collaborating with vendors and contract manufacturers to develop and test prototypes, ensuring seamless execution.
• Leading cross-functional project teams consisting of internal and external resources, encouraging a cooperative and diverse environment.
• Negotiating with suppliers and managing external resources to complete projects on time and within budget.
• Directing technicians and providing mentorship to junior engineers and designers.

Must-Have Skills, Education, and Experience:

• The ideal candidate will have a strong background in mechanical engineering, with extensive experience in the medical device industry and capital equipment design.
• Bachelor's degree in mechanical engineering required, Master's degree in engineering preferred.
• Minimum of 10 years of relevant work experience in electro-mechanical capital equipment design
• Strong Coaching and Team Leadership Skills and Experiences are a must.
• Excellent written & verbal communication skills with ability to clearly articulate solutions to complex technical problems
• Excellent time management and multitasking skills.
• Ability to read and interpret drawings and technical documents.
• Strong analytical skills and problem-solving ability.
• Strong interpersonal skills and ability to effectively work through ambiguity with teammates.
• Knowledge of FDA and ISO regulations.