Bolt Medical is hiring: Senior Manufacturing Engineer, Mechanical in Carlsbad

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RECRUITERS: DO NOT CONTACT.

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.