Compensation Overview

We are looking for a Staff Manufacturing Engineer, to join the Instrument Manufacturing Engineering Team. This individual will play a key role in developing and implementing manufacturing process improvements, equipment/fixture/tooling design and qualification, and process development and qualification, with a focus on delivering high quality products and meeting production demand.  

The ideal candidate will have a strong background in manufacturing and process engineering with knowledge and hands-on experience with contract manufacturing, internal production assembly, calibration and control for instrument or capital equipment manufacturing.

What you will be doing:

• Collaborating with NPI, R&D, QA and Production departments to design, develop, test, document and implement processes, tooling, and fixtures.
• Defining, measuring, and reporting key metrics for production quality and cost.  Analyzing process performance and capabilities for internal manufacturing operations.
• Leading efforts to develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for company processes, implement mitigations, and leverage risked based decision making.  
• Creating process requirements to inform design activities and implement equipment and fixturing needed for process development and manufacturing efforts.
• Developing and maintaining documentation for design and process control, product configurations, manufacturing procedures, (e.g., travelers, bills-of-materials, Work Instructions, Lot History Records), and other Quality System requirements.
• Evaluating existing engineering processes and implementing process improvements. 
• Designing and developing manufacturing test fixtures as required. Designing fixtures and tooling to help reduce cost of machine setup and reduce scrap
• Using Lean principles, Lead and/or actively participate in product/process engineering problem solving.
• Identifying opportunities and implementing changes to improve products and reduce costs by leveraging knowledge of assembly methods, quality control standards, fabrication processes, tooling, production equipment, product design, and materials
• Supporting the transfer of product lines and qualification-validation efforts
• Preparing reports and presentations summarizing information or trends related to manufacturing performance
• Providing technical expertise or support related to manufacturing.

Minimum Requirements: 

• Bachelor’s degree in Engineering: Mechanical, Electrical or Manufacturing with 7 years of experience, or MS/ PhD with 5 years of experience.
• Work history of qualifying multiple manufacturing processes.  
• Ability to review mechanical drawings, ability to read schematics
• Creation of pFMEAs, ECOs, work instructions, and qualification documentation. 
• Experienced in Supplier Engagement and support, domestic and offshore
• Working knowledge of, but not limited to, manufacturing and assembly techniques, machining, injection molding, instrument and consumables for biotech
• Experience working 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, with a compelling technology, and taking products and processes to the next level.

Preferred Qualifications: 

• Experience with SolidWorks, Oracle, Arena is a plus. 
• Lean Six Sigma Green/Black Belt Certification.

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