Lead Mechanical Engineer 4

Hologic•Marlborough, MA

8h•$119,300 - $186,600

About The Position

The Lead Mechanical Engineer provides technical leadership for new product development mechanical workstreams and projects, supporting customer-centric product design from concept through production. The role is accountable for technical quality, cost, schedule, and milestone delivery, and leads mechanical development through design transfer and product launch. This includes product architecture, subsystem definition, interface management, design decisions, and risk management. The engineer leads design of product frames and skins, electromechanical interfaces, and interfaces between reusable consoles and disposable components. The role translates customer, user, regulatory, and system requirements into design inputs, acceptance criteria, and verification plans; establishes technical plans, budgets, schedules, and resource needs; and drives value engineering and cost reduction. The position collaborates with manufacturing teams, suppliers, and cross-functional partners, and provides technical direction, coordination, review, and mentorship to engineers and project contributors. The role also leads prototypes, investigations, verification and validation, design transfer, and production-readiness activities. It prepares, reviews, and approves mechanical design deliverables and project documentation, evaluates new technologies and processes, and contributes technical scope, estimates, schedules, and resource requirements to proposals and business planning. The position requires a bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field, with relevant medical-device research and development experience. The stated experience ranges are 8–10 years with a bachelor's degree or 6–8 years with a master's degree.

Requirements

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field, with research and development experience in the medical device industry.
8–10 years of work experience in the health and/or business communities with a bachelor's degree, or 6–8 years with a master's degree.
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 skills, including ability to author protocols, reports, requirements, and risk documentation with minimal guidance.
Experimental, computational, and analytical skills, such as DFSS tools and statistical methods including design of experiments (DOE) and MiniTab.
Proficiency using CAD; SolidWorks is preferred.
Experience with electromechanical interface design and 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 (DFM/DFA) 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 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 while balancing stiffness, weight, alignment, appearance, assembly variation, access, and serviceability.
Cost-aware CAD and drawing practices, including creating robust, maintainable SolidWorks assemblies and production-ready drawings; applying functional datums and appropriate GD&T; and avoiding over-tolerancing or unnecessary complexity.
Supplier and manufacturing collaboration skills, including engaging suppliers and manufacturing engineers early, 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.
Clear communication of costs and tradeoffs to program leads and stakeholders, including assumptions, risks, verification needs, and schedule or tooling impacts.
Ability to stay informed of new methods and developments affecting the organization and recommend new practices or changes.
Ability to travel as necessary, up to 10%.

Nice To Haves

SolidWorks proficiency is preferred.

Responsibilities

Provide technical leadership for new product development mechanical workstreams and projects, accountable for technical quality, cost, schedule, and delivery of milestones.
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, including integration of components such as pumps with console structure, 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 as appropriate.
Drive value engineering and cost reduction against product cost targets; evaluate designs, materials, manufacturing processes, suppliers, tooling, and assembly methods, and document savings while verifying 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.