Objective:The Senior Mechanical Design Engineer is a senior-level individual contributor responsible for leading the design and development of ophthalmic surgical devices, capital equipment, accessories, and procedural systems throughout the product lifecycle. This role serves as a technical leader and subject matter expert, applying advanced mechanical and electro-mechanical engineering expertise to drive innovation from concept through commercialization. Working cross-functionally with Marketing, Manufacturing, Quality, Regulatory, and Clinical teams, the Senior Mechanical Design Engineer ensures products meet customer needs, regulatory requirements, and business objectives. This position may lead technical aspects of development projects and provide mentorship to engineers but does not have direct people-management responsibilities.
Responsibilities:- Serve as the technical lead and subject matter expert for one or more core technologies, product platforms, or strategic product lines, providing technical direction and design decision-making throughout the product lifecycle.
- Lead mechanical and electro-mechanical design activities for new product development projects.
- Generate and evaluate design concepts based on customer, clinical, and marketing requirements.
- Collaborate with Marketing, Manufacturing, Quality, Regulatory, and Clinical teams to ensure products meet design requirements and customer expectations.
- Develop, maintain, and review design documentation in compliance with FDA CFR 820 Quality System Regulations, ISO 13485 requirements, and company design control procedures.
- Create and maintain 3D CAD models and detailed engineering drawings using SolidWorks, Autodesk Inventor, or equivalent software.
- Perform engineering analyses, including tolerance stack-up studies, performance optimization, and engineering calculations to support product design and verification.
- Design, build, and evaluate prototypes to verify product functionality and performance.
- Author test protocols, execute testing, analyze results, and prepare technical reports.
- Support product verification and validation activities and document results.
- Participate in customer visits, clinical evaluations, and operating room observations, as needed, to gather user insights and identify product improvement opportunities.
- Lead root-cause investigations of product performance issues, customer complaints, and nonconforming materials, and support implementation of corrective and preventive actions (CAPA).
- Provide technical leadership for sustaining engineering efforts, product improvements, and manufacturing support initiatives.
- Mentor and provide technical guidance to engineers and cross-functional team members to advance engineering capability and project execution.
Qualifications:Required Experience:
- Bachelor's degree in Mechanical Engineering or related engineering discipline with 5+ years of product development experience; or
- Experience developing products within a regulated environment, preferably medical devices operating under ISO 13485 and FDA CFR 820 design control requirements.
- Candidates with equivalent experience developing sophisticated electro-mechanical products in consumer, industrial, aerospace, or defense industries will also be considered.
Required Skills/Qualifications:
- Proficiency creating 3D CAD models, assemblies, and engineering drawings using SolidWorks, Autodesk Inventor, or equivalent CAD software.
- Ability to interpret and create engineering drawings, specifications, reports, and other engineering or manufacturing documentation.
- Strong knowledge of electro-mechanical systems, devices, and materials including pneumatic systems and fluidic management systems.
- Expertise in mechanical design and tolerance analysis.
- Experience specifying, integrating, and validating sensors, instrumentation, and automated test equipment used in product development and verification.
- Working knowledge of electrical systems and experience collaborating on the integration of electrical, software, and mechanical subsystems within electro-mechanical products.
- Proficiency with Microsoft Office Suite and engineering-related software applications.
- Excellent oral and written communication skills.
- Demonstrated ability to work cross-functionally.
Preferred Experience
- 7+ years of progressive product development experience involving the design of electro-mechanical medical devices or accessories.
- Master's degree or PhD in Mechanical Engineering or related engineering discipline with 3+ years of product development experience.
- Demonstrated technical expertise in one or more of the following areas associated with medical device development:
- Pneumatic systems
- Hydraulic systems
- Fluid management systems
- Vibrations and acoustics
- Automated machinery and capital equipment development
- Precision motion control systems
- Experience with Design for Six Sigma (DFSS), Quality Function Deployment (QFD), Design for Manufacturability (DFM), and Design for Assembly (DFA) methodologies.
- Demonstrated record of technical innovation through patents, invention disclosures, peer-reviewed publications, or successful commercial product introductions.
U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
