Senior Manufacturing Engineer
1 month ago
Job Type: Full-Time, direct hire
Shift: Days
About Us: We are an established and growing company in the medical device industry, known for our commitment to innovation, precision, and quality in manufacturing. Our mission is to enhance healthcare through cutting-edge technology and manufacturing excellence. Join our team where your expertise in manufacturing will directly impact patient care.
Position Overview: We are seeking an experienced Senior Manufacturing Engineer with a specialized focus on CNC Swiss, milling, grinding, and SolidWorks. This role will lead the design, implementation, and continuous improvement of manufacturing processes for medical devices, ensuring compliance with industry standards while driving efficiency and quality.
Key Responsibilities
Process Development & Optimization: Oversee the design and enhancement of manufacturing processes for CNC Swiss lathes, milling, and grinding operations, utilizing SolidWorks for design and analysis.
Quality Leadership: Champion quality improvement initiatives, implementing Six Sigma, Lean manufacturing, and other methodologies to elevate product quality and process efficiency.
Regulatory Compliance: Ensure manufacturing processes adhere to GMP, ISO 13485, and other relevant medical device regulations.
Project Management: Lead cross-functional teams in project execution, from concept through to production, focusing on improving manufacturability, reducing costs, and enhancing production flow.
Technical Expertise: Provide expert-level programming for CNC machines, develop tooling, and implement automation where appropriate to increase production efficiency.
Continuous Improvement: Drive kaizen events, conduct FMEAs, and implement SPC to enhance production processes continually.
Team Leadership: Mentor and guide junior engineers and technicians, fostering a culture of innovation and continuous learning.
Stakeholder Communication: Interface with various departments, vendors, and external partners to ensure seamless operation and compliance with standards.
Qualifications:
Minimum of 8 years of experience in a manufacturing engineering role, with at least 5 years in medical device manufacturing.
Extensive experience with CNC Swiss, milling, and grinding operations.
Proficiency in SolidWorks and CAM software for design and manufacturing.
Strong background in quality systems
Demonstrated leadership experience in a manufacturing environment.
Excellent problem-solving skills with a proactive approach to process improvement.
Knowledge of medical device regulations and standards, including biocompatibility and sterile processing.
Ability to manage multiple projects with competing deadlines.
Excellent communication skills with the ability to work collaboratively across departments.
What We Offer:
Competitive salary commensurate with experience, including performance bonuses.
Comprehensive health, dental, and vision benefits.
Support for continuous education and professional development.
A dynamic, supportive work environment that values innovation and work-life balance.
Opportunity to make a tangible difference in healthcare through advanced manufacturing technologies.
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