Senior Manufacturing Engineer – Medical Devices 

Role Overview

Seeking a seasoned Senior Manufacturing Engineer to optimize and scale our medical device production in a highly-regulated environment. You’ll collaborate with cross-functional teams and contract manufacturers to ensure robust, compliant, and efficient manufacturing processes.

 Key Responsibilities

• Manufacturing Process Design: Develop and validate cost-effective assembly, testing, sterilization, and packaging workflows—ensuring seamless design transfer and scale-up.
• Contract Manufacturer Coordination: Manage relationships, equipment, and process implementation at CMOs—overseeing IQ/OQ/PQ and equipment qualification.
• Lean/Six Sigma Optimization: Facilitate continuous improvement using Six Sigma, Lean, DFMEA, process validation, and scrap-reduction techniques.
• Documentation & Compliance: Maintain accurate BOMs, work instructions, SOPs, validation protocols, and ensure FDA, ISO 13485, cGMP adherence.
• Cross-functional Collaboration: Work closely with R&D, quality, supply chain, and suppliers to align production scale-up with technical and regulatory requirements.
• Training & Coaching: Provide mentorship to junior engineers and support operator training during new product launches or process transitions.

Required Qualifications

• Bachelor’s (or Master’s) in Mechanical, Biomedical, or Manufacturing Engineering.
• 8+ years’ experience leading medical device manufacturing projects, scaling from prototyping to commercial production.
• Proficient in SolidWorks or similar CAD tools.
• Demonstrated expertise in process validations (IQ/OQ/PQ), DFMA, Lean, Six Sigma, pFMEA, and statistical methods (SPC, DOE). 
• Strong understanding of FDA 21 CFR Part 820, ISO 13485, and cGMP standards 
• Proven experience coordinating with contract manufacturers and managing design transfers.

Preferred Qualifications

• Lean or Six Sigma certification (e.g., Green/Black Belt).
• Experience with catheter, capital equipment, or electronics in a contract manufacturing setting. 
• Familiarity with sterilizable polymers, packaging engineering, or automation systems.
• Excellent project management and communication skills.