About the Role:

As a Senior Mechanical Engineer, you will play a pivotal role in leading the mechanical design of complex biotech consumables from concept through production. 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:

• Lead the mechanical design of complex biotech consumables from concept through production
• Focus on injection-molded (IM) plastics, over-molding, LSR, and advanced assembly techniques like ultrasonic welding and laser bonding
• Design for Manufacturing (DFM) and Design for Assembly (DFA), working closely with toolmakers and CMOs to ensure tool designs and strategies are optimized
• Vendor Management - Act as the primary technical point of contact for external molding partners and material suppliers, ensuring quality and performance standards are met
• 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

• 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.

Minimum Requirements:

• Bachelor’s or Master’s degree (or equivalent) in Mechanical Engineering or a related field
• Multi-year 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

Preferred Qualifications:

• Deep knowledge of thermoplastic resins (COC, COP, PC, PP), elastomers (TPE/TPU), and the nuances of high-volume injection molding
• 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.)

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