Staff Engineer, Manufacturing

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• Bachelor’s Degree in Mechanical, Industrial, Biomedical, or related Engineering from an accredited university
• A minimum of 8 years of manufacturing engineering (equipment/process design and support) in a regulated industry such as Medical Device, Pharmaceutical, or food; OR a master’s degree in related field plus 6 years’ experience
• A minimum of 1 year of FDA validation experience for equipment qualification and process validation

• Experience with medical device manufacturing and inspection technologies (heat staking, manual assembly, discrete manufacturing, ultrasonic/laser welding, press assembly, adhesives, leak testing, vision systems, and robotics, preferred)
• Experience in a high-volume manufacturing environment preferred, i.e. production 1M+ annual, cycle time < 7 second.
• Six Sigma Black Belt (CSSBB) or Lean Six Sigma Certification
• Ability to effectively create 3D engineering models, assemblies, fixtures, and drawings (Solidworks preferred)
• Ability to create proof of principle, experimental designs and collect, interpret, and analyze data using statistical techniques (Minitab preferred)
• Strong technical writing skills (planning, protocol writing, execution, report writing)
• Demonstrate excellent understanding of medical device product development including risk management methodologies
• Knowledge of PLC and HMI programming for equipment troubleshooting or minor modifications (Allen Bradley preferred)
• Strong understanding and application of 21 CFR 820 Medical Device Quality System Regulation, especially 21 CFR 820.70 for equipment qualification and 21 CFR 820.75 for process validation (FAT, SAT, IOQ, OQ, PQ, PPQ)
• Must be able to work effectively on electrical, mechanical, and/or software related issues associated with equipment
• Strong analytical and creative problem-solving skills, able to provide solutions to complex technical challenges, focusing on design for manufacturing on manual and automated applications
• Resolve highly sensitive and complex issues within the department
• Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook)
• Demonstrated ability to prioritize tasks and lead a varied workload to meet team objectives
• Demonstrated technical coaching and leadership of peers
• Strong demonstrated ability to deliver manufacturing projects in a timely manner and execute on high-quality deliverables to meet defined goals
• Anticipates the need to shift priorities to provide the best possible response to cross functional teams
• Apply strong cognitive ability to collecting, processing, and disseminating information
• Strong ability to foster teamwork, collaboration, negotiation, coaching, and influencing others
• Make a positive impact on others in support of company goals and a healthy work environment

• Must be able to remain in a stationary position for extended periods of time
• Must be able to access and navigate all areas of the facility, including clean rooms, and labs
• Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
• Ability to work within, crouch, stoop, bend around and potentially underneath equipment for extended periods of time
• Position requires being physically present on the premises during regular company hours or as approved by management

• Lead process design and optimization through design of experiments and engineering studies
• Lead manufacturing equipment specification, design, development, construction, implementation, or modification
• Troubleshoot and implement solutions to aid in the manufacture of the product. Typical solutions require changes to assembly equipment and/or the modification of part/mold design and inspection criteria to improve the quality, reproducibility, efficiency or safety of the manufacturing processes
• Equipment Qualification (installation, operational and process qualifications (IQ/OQ/PQ) to meet regulatory requirements
• Create test protocols to challenge equipment performance against intended specifications. Execute protocols and write validation reports
• Design and execute Measurement System Analysis (MSA) such as…