Lead Design Engineer

Overview

A large medical device manufacturing client is seeking a Design Engineering Lead to 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).

The ideal candidate will have a strong background in mechanical engineering, with extensive experience in the medical device industry and capital equipment design. Responsibilities include creating comprehensive design documentation, overseeing testing in both bench and clinical environments, and ensuring seamless execution through vendor and supplier coordination.

• Designing electro-mechanical reusable/capital medical devices from concept through design freeze.
• 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.

• Bachelor’s degree in mechanical engineering required.
• Minimum of 10 years of relevant work experience in electro-mechanical capital equipment design
• 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.
• This role also requires domestic and international travel to support development efforts.