Senior Mechanical Design Engineer

We are seeking an experienced and highly skilled Senior Mechanical Designer to lead the mechanical design and execution of cutting-edge diagnostic, automation, and medical device systems. This role combines deep hands-on design capability with cross-functional project ownership, production handover, and vendor management. You will work closely with interdisciplinary teams to take concepts through prototyping, testing, and scaled manufacturing.

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Key Responsibilities:

Mechanical Design & Development

1. Lead the mechanical design of complex electromechanical systems involving precision parts, enclosures, mechanisms, and fluidic components.
2. Create 3D and 2D CAD models for assemblies and subassemblies using parametric and surface modeling techniques.
3. Apply best practices for DFM (Design for Manufacturing), DFA (Design for Assembly), and reliability engineering in all designs.
4. Architect high-precision systems involving optical alignments, microstructures, thermal interfaces, and motion subsystems.
5. Design enclosures and internal mechanical parts using sheet metal, injection-molded plastics, and machined components.

Mechanism and SPM Development

1. Design special purpose machines, lab automation fixtures, and modular testing platforms.
2. Integrate actuators, stepper motors, linear motion components, and control interfaces.
3. Design mechanisms such as linkages, spring-loaded systems, drive trains, gearboxes, and linear cam assemblies.

Fluidic System Integration

1. Design custom fluidic pathways involving pumps, valves, manifolds, reservoirs, microchannels, and seals.
2. Integrate mechanical components with biosensors and fluidic cartridges.
3. Collaborate with cross-functional teams to manage mechanical-electrical-fluidic interfacing.

Prototyping and Validation

1. Lead hands-on prototyping through 3D printing, laser cutting, CNC machining, and hand-assembly.
2. Design and conduct mechanical validation protocols including stress testing, vibration testing, and thermal cycling.
3. Perform tolerance stack-up analysis, failure mode analysis, and root cause resolution for mechanical issues.

Project and Documentation Ownership

1. Take ownership of mechanical workstreams within product and research projects.
2. Generate detailed drawings, BOMs, exploded views, and assembly SOPs.
3. Lead design reviews, risk reviews (DFMEA/FMEA), and version-controlled document management.
4. Mentor junior engineers and ensure high technical standards across the team.

Production and Vendor Interface

1. Coordinate with vendors and fabricators for rapid prototyping and production tooling.
2. Guide production engineering on jigs, fixtures, tooling, and quality assurance processes.
3. Support pilot production and scale-up by refining designs, improving yields, and optimizing assembly flow.
4. Participate in first article inspection (FAI), vendor audits, and production part approval processes.

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Technical Skills Required:

Design and CAD

• Advanced 3D modeling using SolidWorks, Fusion 360, Creo, or similar CAD platforms.

• Proficient in sheet metal design, injection-molded plastic parts, and machined components.

• Expertise in tolerance analysis, GD&T, and design control documentation.

• Strong grasp of complex mechanism design, moving parts, and interlocking assemblies.

• Familiarity with simulation tools for stress, flow, and thermal modeling is a plus.

Mechanical Engineering Fundamentals

• Deep understanding of material selection, fatigue, failure modes, and mechanical loads.

• Experience with sealing systems, IP-rated enclosures, cable routing, and EMI shielding.

• Knowledge of fluid dynamics and fluid handling systems (positive/negative pressure, reservoirs, air traps, etc.).

Cross-functional Integration

• Ability to work closely with electronics, software, biosensor, and QA teams.

• Familiarity with integration of PCB assemblies, wiring harnesses, and connector placement.

• Comfort in working with clinical, QA/RA, and user-experience teams to refine products.

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Preferred Qualifications:

• Bachelor's or Master's degree in Mechanical Engineering, Mechatronics, or related discipline.

• 10-12 years of experience in product development, preferably in medical devices, diagnostics, lab automation, or industrial automation.

• Experience with ISO 13485, IEC 60601, or equivalent design control and compliance frameworks is a strong advantage.

• Prior experience in managing projects and mentoring junior engineers.