Senior Manufacturing Engineer, Mechanical Job at Bolt Medical in Carlsbad

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Role Description

The Sr. Manufacturing Engineer, Mechanical will be responsible for design, development, and optimization of manufacturing processes. Work to improve efficiency, reduce costs, and enhance product quality in a production environment. Responsibilities include: DFM analysis, evaluating process, testing, updating mechanical systems, updating component drawings and manufacturing procedures. This position requires a strong understanding of mechanical engineering principles and the ability to work collaboratively with cross-functional teams to transfer systems from R&D to Manufacturing. The ideal candidate will have a background in mechanical design, analysis, and manufacturing processes.

Roles and Responsibilities:

• Sustaining Engineering: Design transfer of an electro-mechanical system to manufacturing. Perform DFM analysis for all mechanical systems, assemblies, components and implement changes as required to ensure manufacturability.
• 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.

Education:

• Bachelors Degree or equivalent in Mechanical Engineering, Optical Engineering, Physics, or similar disciplines with three or more years of relevant experience. A masters degree or PhD can be substituted for relevant experience.

Required Experience:

• 3+ years of experience in mechanical design and development, preferably in a manufacturing or product development environment.
• Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and other engineering analysis tools.
• 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 in lasers, photonics and optics.
• 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.
• Biomedical product, medical device development experience preferred.
• Optomechanical 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.
• Understanding of Design Controls according to ISO 13485 or 21 CFR 820.
• Six Sigma experience/training is an advantage.