Engineering Manager - Combo Product - Boston

As a Engineering Manager, you will lead the design, development, and commercialization of our novel combination devices. In this role, you will be responsible for managing and executing all aspects of device development, from concept generation and prototyping to validation and manufacturing transfer.

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Client Details

The organization is a dynamic and rapidly growing combination device startup based near Boston, MA. Their mission is to develop innovative medical devices that integrate multiple technologies to improve patient outcomes and revolutionize healthcare.

Description

The below are some of the responsibilities for the Engineering Manager :

• Lead the design and development of innovative combination devices from concept to commercialization, adhering to project timelines, budgets, and quality standards.
• Manage a team of junior engineers and mentor them.
• Drive the creation and implementation of robust engineering strategies and project plans, ensuring efficient development processes and effective resource utilization.
• Conduct comprehensive technical analyses, feasibility studies, and risk assessments to support design decisions and optimize device performance.
• Generate and review design documentation, including specifications, drawings, and test protocols, ensuring compliance with applicable regulations and standards.
• Collaborate closely with cross-functional teams to integrate drug delivery systems with advanced technologies, such as electronics, software, and connectivity.
• Perform design verification and validation activities, including conducting testing, analyzing data, and generating reports to support regulatory submissions.
• Identify and mitigate technical challenges and project risks through proactive problem-solving and continuous improvement initiatives.
• Provide technical leadership and mentorship to junior engineers, fostering a collaborative and innovative engineering culture.
• Stay current with industry trends, emerging technologies, and regulatory requirements related to combination devices, and apply that knowledge to drive innovation and enhance product development strategies.

Profile

The successful Engineering Manager candidate will have the following skillset :

• Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or a related field. A Ph.D. is a plus.
• At least 5 years of engineering management experience.
• Extensive experience (8+ years) in the design, development, and commercialization of medical devices, preferably combination products or drug delivery systems.
• Strong expertise in engineering principles, including mechanical design, materials selection, and manufacturing processes.
• Proficiency in CAD software (e.g., SolidWorks) and familiarity with simulation tools.
• In-depth knowledge of relevant regulations and standards, such as ISO 13485, FDA QSR, and IEC 60601.
• Proven track record of leading successful device development projects, from concept to commercialization.
• Experience in risk management, design verification / validation, and regulatory submissions.
• Excellent problem-solving skills and the ability to work in a fast-paced, startup environment with ambiguity and evolving priorities.
• Strong leadership and communication skills, with the ability to collaborate effectively with cross-functional teams.

Job Offer

The Engineering Manager will be offered a competitive salary and a comprehensive benefits package, along with the opportunity to be part of an exciting startup environment at the forefront of medical device innovation.

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