Lead Mechanical Engineer 4

Hologic • Marlborough, MA

4d

About The Position

The Lead Mechanical Engineer provides technical leadership and strong customer-centric design judgment for medical-device new product development, from concept through production, design transfer, and product launch. The role is accountable for the technical quality, cost, schedule, and delivery of mechanical workstreams and milestones, and receives strategic supervision while managing assigned work.

The engineer leads product architecture, subsystem definition, interface management, design decisions, and risk management. Work includes frames and skins; electromechanical interfaces; and interfaces between reusable consoles and disposable components. Designs must balance performance, weight, appearance, cleanability, serviceability, manufacturability, usability, reliability, and cost. The role translates customer, user, regulatory, and system requirements into design inputs, acceptance criteria, and verification plans.

The position establishes technical plans, budgets, schedules, and resource needs; drives value engineering and cost reduction; and works with manufacturing teams and suppliers on design for manufacturing and assembly. It coordinates with electrical, EMC, systems, quality, regulatory, human-factors, and other functions. The engineer leads technical reviews, prototype builds, investigations, verification and validation, design transfer, and production-readiness activities; provides technical direction and mentorship; and prepares, reviews, and approves mechanical design deliverables and project documentation.

The role also evaluates new technologies and processes and contributes to project proposals and business planning by developing or reviewing technical scope, estimates, schedules, and resource requirements. Travel may be required up to 10%.

Requirements

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field, with research and development experience in the medical-device industry.
• With a bachelor's degree, 8–10 years of work experience in the health and/or business communities; with a master's degree, 6–8 years of work experience in the health and/or business communities.
• Action- and detail-oriented, with an aptitude for technical learning.
• Strong functional and technical skills, problem-solving skills, and drive for results.
• Ability to apply knowledge and expertise acquired through progressive experience to resolve crucial issues and unique conditions.
• Strong technical writing ability, including ability to author protocols, reports, requirements, and risk documentation with minimal guidance.
• Experimental, computational, and analytical skills, including DFSS tools and statistical methods such as design of experiments (DOE) and MiniTab.
• Proficiency using CAD; SolidWorks preferred.
• Experience with electromechanical interface design.
• Experience with disposable-to-reusable product interfaces, including material selection, reliability, performance, and usability.
• Proven cost-out and value-engineering capability, including establishing a cost baseline, identifying major cost drivers, and delivering documented savings.
• Design-for-manufacturing and assembly capability, including designing practical parts and reducing part count, fasteners, complex setups, tight tolerances, secondary operations, and rework while preserving function.
• Understanding of manufacturing-process selection, including choosing among bent sheet metal, machined parts, castings, molded plastics, or alternatives based on volume, geometry, tolerances, tooling investment, supplier capability, and total cost.
• Ability to design frames and skins as an integrated system, balancing stiffness, weight, alignment, appearance, assembly variation, access, and serviceability.
• Cost-aware CAD and drawing practices, including robust and maintainable SolidWorks assemblies, production-ready drawings, functional datums, appropriate GD&T, and avoidance of unnecessary over-tolerancing or complexity.
• Supplier and manufacturing collaboration skills, including early engagement, incorporating process feedback, understanding quotes and cost breakdowns, and evaluating tooling and sourcing tradeoffs.
• Foundational knowledge of EMC-aware mechanical design, including how enclosure seams, apertures, grounding, bonding, materials, and coatings may affect radiated emissions.
• Experience developing mechanical requirements and associated test methods to verify designs.
• Exceptional communication of cost and tradeoffs to program leads and stakeholders, including assumptions, risks, verification needs, schedule impacts, and tooling impacts.
• Ability to work flexible hours.
• Ability to travel as necessary, up to 10%.

Responsibilities

• Provide technical leadership for new product development mechanical workstreams and projects, accountable for technical quality, cost, schedule, and milestone delivery.
• Lead mechanical development from concept through design transfer and product launch, including product architecture, subsystem definition, interface management, design decisions, and risk management.
• Lead development of product frames and skins, balancing structural performance, weight, appearance, cleanability, serviceability, manufacturability, and cost.
• Lead mechanical design of electromechanical interfaces and integration of components with console structures, mechanisms, electrical systems, and fluid pathways.
• Lead design of interfaces between reusable consoles and disposable components, addressing alignment, connection, retention, usability, leak prevention, and reliable operation.
• Translate customer, user, regulatory, and system requirements into mechanical design inputs, acceptance criteria, and verification plans.
• Establish mechanical design strategies, technical plans, budgets, schedules, and resource needs; communicate status and escalate risks and issues.
• Drive value engineering and cost reduction against product cost targets; evaluate designs, materials, manufacturing processes, suppliers, tooling, and assembly methods; document savings and verify requirements are preserved.
• Lead design for manufacturing and assembly with internal manufacturing teams and suppliers, considering machining, casting, sheet-metal fabrication, injection molding, and plating.
• Coordinate mechanical design with electrical, EMC, systems, quality, regulatory, human-factors, and other functions, including enclosure shielding, bonding, and plating strategies where required.
• Lead technical reviews, facilitate decisions on complex design tradeoffs, and present recommendations, risks, and supporting data to project teams and stakeholders.
• Provide technical direction to engineers and project contributors; coordinate work, review deliverables, and mentor and develop less-experienced engineers.
• Lead prototype builds, engineering investigations, and verification and validation activities; use test results and root-cause analysis to resolve issues and guide design improvements.
• Lead design-transfer and production-readiness activities, including supplier engagement, process and inspection planning, documentation, and resolution of build issues through launch.
• Prepare, review, and approve mechanical design deliverables and project documentation for technical completeness, quality, and applicable standards.
• Evaluate new technologies, materials, methods, and engineering processes that may improve product performance, manufacturability, reliability, or cost.
• Contribute to project proposals and business planning by developing or reviewing technical scope, estimates, schedules, and resource requirements.
• Keep informed of new methods and developments affecting the organization and recommend new practices or changes.

Benefits

• Comprehensive training upon joining and continued development and training throughout the career.
• Competitive salary.
• Annual bonus scheme; the position is bonus eligible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior