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Position overview: The Principal Mechanical Engineer will be responsible for design, development, and optimization of complex parts and assemblies. In addition, the candidate will be responsible for leading the mechanical engineering efforts across multiple projects from initial concept, through all phases to final product commercialization. This role requires a deep understanding of mechanical design, materials, engineering principles, and regulatory standards, as well as experience in the development of products within the medical device industry. Work to improve efficiency, reduce costs, and enhance product quality in a production environment. Responsibilities include: DFM/FEA analysis, Tolerance stack up for assemblies using statistical techniques, evaluating process, testing, updating mechanical systems, updating component/assembly drawings and manufacturing procedures. Excellent communication skills are essential to work collaboratively with cross-functional teams to design/develop and transfer systems from R&D to Manufacturing. The ideal candidate will have a background in mechanical design, analysis, and manufacturing processes.

Responsibilities:

R&D Engineering: Concept, design, and development of electro-mechanical systems. Perform comprehensive FEA analysis, DFM, DFA for assemblies, components, sub-systems to ensure manufacturability and reliability.

Analysis: Perform engineering calculations such as tolerance stack analysis using statistical methods to ensure the integrity and performance of mechanical designs for high volume manufacturing processes.

Fixturing and Tooling: Design and develop manufacturing processes, tooling equipment, and conduct testing to validate design concepts and verify performance requirements.

Manufacturing Support: Collaborate with manufacturing teams to optimize designs for manufacturability and provide technical support during production.

Documentation: Prepare technical documentation, including IQ/OQ/PQ, engineering drawings, specifications, and Manufacturing Procedures.

Continuous Improvement: Identify opportunities for improvement in existing designs and processes to enhance product performance, reliability, and cost-effectiveness. Analyze production workflows and identify areas for improvement. Troubleshoot manufacturing issues and implement corrective actions. Conduct time and motion studies to improve efficiency.

Cross-functional Collaboration: Work closely with other engineering disciplines, such as electrical and software engineering, as well as with product management and quality assurance teams, to meet project goals and objectives.

Qualification:

Education:

Bachelor’s Degree or equivalent in Mechanical Engineering, Optical Engineering, Physics, or similar disciplines with eight or more years of relevant experience. A master’s degree can be substituted for relevant experience.

Required Experience:

• 8+ years of experience in mechanical design and development within the medical device industry, with a proven track record of bringing products to market.
• Experience in leading mechanical design efforts for Class I, II, or III medical devices.
• Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and other engineering tools such as MiniTab, MATLAB, MS Excel.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work effectively both independently and as part of a team. Hands-on experience in laboratory technical work, preferably medical device systems.
• Experience in documenting technical work and results, writing lab reports, statistical analysis, and presentation of data.
• Excellent written and verbal English communication skills are required.

Knowledge, Skills, and Abilities:

• Proficiency with SolidWorks 2020 and above.
• Biomedical product, medical device development experience preferred.
• Electromechanical design, GD&T, tolerance analysis.
• Development of laser/optic energy delivery devices, and laser systems is an advantage.
• Experience with Q-switched, fiber optic or other high-energy lasers and related optical and optomechanical hardware is an advantage.
• Experience with Class 3B & Class 4 lasers and related optics for energy delivery and related single-use devices is an advantage.
• Understanding of Design Controls according to ISO 13485 or 21 CFR 820.