Tech Stack

Description

You will lead mechanical engineering efforts for new product introduction, designing manufacturing fixtures and processes, and collaborating with cross-functional teams to ensure high-quality production. This role focuses on process improvement, risk-based decision making, and supporting product transfers.

Requirements

• Bachelor's degree in Mechanical Engineering with 5 years of experience, or MS/PhD with 4 years.
• Strong background in mechanical design for complex capital equipment, ideally including optics, motion systems, and fluidics.
• Ability to review mechanical drawings and read schematics.
• Proficient in SolidWorks for 3D CAD modeling, design analysis, and detailed mechanical drawings.
• Creation of pFMEAs, ECOs, work instructions, and qualification documentation.
• Working knowledge of manufacturing and assembly techniques, machining, injection molding, instrument and consumables for biotech.
• Experience with instrument manufacturing under ISO 9001 or ISO 13485 standards.
• Expertise in cGDP, cGMP.
• Ability to travel to contract manufacturers (approximately 10%).
• Desire to be part of a rapidly evolving organization.

Responsibilities

• Lead and support mechanical engineering efforts for NPI, covering design development, verification, validation, and production transfer.
• Design and development of manufacturing test fixtures as required.
• Design fixtures and tooling to help reduce cost of machine setup and reduce scrap.
• Team with R&D, QA and Production departments to design, develop, test, document and implement processes, tooling, and fixtures.
• Lead effort to develop and maintain process Failure Modes and Effects Analyses (pFMEAs) and implement mitigations.
• Create process requirements for equipment and fixturing needed for process development and manufacturing.
• Develop and maintain documentation for design and process control, product configurations, manufacturing procedures, and other Quality System requirements.
• Evaluate existing engineering processes and implement process improvements using Lean principles.
• Identify opportunities and implement changes to improve products and reduce costs.
• Support the transfer of product lines and the qualification-validation efforts.
• Prepare reports and presentations summarizing information or trends related to manufacturing performance.
• Provide technical expertise or support related to manufacturing.