Sr. Mechanical Engineer

About the Role:

As a Senior Mechanical Engineer, you will play a pivotal role in leading the design, development, and optimization of complex mechanical systems for biotech applications. You will be a key technical contributor, problem solver, and mentor, working across disciplines to drive innovation and ensure system success. Your expertise in mechanical design, prototyping, testing, and regulatory compliance will be instrumental in delivering high-performance, scalable solutions that meet the stringent demands of biotech environments.

What you will be doing:

• Contribute to the design and development of high-complexity mechanical systems for biotech applications, ensuring seamless integration with biological and chemical workflows.
• Apply advanced engineering principles in mechanics, thermodynamics, fluid dynamics, and materials science to solve intricate design challenges.
• Drive prototype development and oversee rigorous validation testing to ensure optimal system performance.
• Ensure designs meet relevant regulatory standards (e.g., FDA, ISO, GMP) in partnership with compliance teams.

• Drive projects from concept to commercialization, managing scope, schedules, risks, and trade-offs.
• identify risks early, and implement mitigation strategies to maintain timelines and budget.
• Act as a technical liaison between mechanical engineering and cross-functional teams (e.g., R&D, software, manufacturing, quality assurance) to ensure system integration.
• Work with vendors and suppliers, ensuring quality and reliability in externally sourced components.

• Participate in failure mode analysis and implement corrective design improvements to enhance reliability and manufacturability.

• Present project updates and design proposals to project leadership, ensuring alignment with project objectives.
• Foster a collaborative team environment, mentoring junior engineers and driving knowledge-sharing initiatives.

To be successful in the role, you will need:

• Bachelor’s or Master’s degree in Mechanical Engineering or a related field.
• 7+ years of experience in mechanical design and product development, preferably in biotech, medical devices, or related industries.
• Proficiency in CAD tools (e.g., SolidWorks, Creo, or equivalent) and engineering analysis tools.
• Strong understanding of mechanical system integration, prototyping, and validation testing.
• Experience with regulatory requirements (e.g., FDA, ISO 13485, GMP) for biotech or medical device applications.
• Demonstrated ability to lead projects, mentor engineers, and drive cross-functional collaboration.

Nice to have skills & Background

• Experience in fluidic systems, thermal management, or precision mechanics for biotech applications.
• Knowledge of manufacturing processes, including injection molding, machining, and 3D printing.
• Familiarity with risk assessment methodologies (FMEA, DFMEA, etc.).