Title: Mechanical Manufacturing Engineer Level II or III
Location: Lake Forest, CA
Compensation: DOE $100-135K + bonus + stock + Career Growth
Must Have: Five years Design & 6 years Manufacturing
Seeking a Mechanical Manufacturing Engineer Level Il or Level III to work with a team of engineers on the continuous development of handheld medical devices. Provide design expertise and integration in the area of Mechanical Engineering development of new products and accessories in the field of non-invasive monitoring technologies. Work with a collaborate team of professionals and watch your career grow!
What You Will Be Doing
Plan and assist with the direction of new product development
Perform product development activities, assist with modifying plans and/or improve and support existing processes
Direct and facilitate testing of new products to verify product reliability
Development of technical protocols and reports, writing & setting up control of documentation system
Advanced understanding of statistical analysis principles as they relate to data analysis and testing reports
Develop high-volume disposable sensors and reusable sensors from concept to product launch
Collaborate with colleagues to maintain a mutual understanding of product needs, regulatory, and production requirements
Generate complete engineering drawings and documentation of all design output
Develop systems and processes for high-volume production
Design and implement automated processes
Strong Desired Experience
Microliter volume pumps and actuation
Sterile operations (processes) and material selection.
Knowledge of:
- FDA 510(k) approval process
- ISO standards
- GMP regulations
What You Need for this Position
Bachelors of Science, Masters desired
5+ years Design Experience (ability to design for production or a related discipline)
6+ years Manufacturing Experience (High volume) and costing.
Medical device industry, preferably in physiological monitoring
Experience leading an engineering team
Injection Molding/ Over-Molding
Micro Molidng, micro stamping, micro fluid HUGE PLUS
Consumable products preferred to have Medical device industry
Materials experience such as metals, plastics, adhesives helpful
Solidworks and Product Data Managemeng experience
Product Packaging
Success taking a device from development to customer shipment
Managing manufacturing vendors
What's In It for You
Medical (HMO or PPO), dental and vision
Flexible spending plan for dependent care and medical
401k (no matching yet)
Bonus plan
Stock options
Vacation (starting at 3 weeks)
Sick time
Short & long-term disability
Lunch on Mondays
Breakfast for early birds
Career Advancement
A COVID-19 vaccine is required for this position by the client for whom we are recruiting. If there is a bona fide medical or religious reason why you cannot be vaccinated, please be prepared to discuss that with the client hiring manager or their HR representative. CyberCoders will not inquire regarding your vaccination status.
Colorado employees will receive paid sick leave. For additional information about available benefits, please contact Nyna Goldberg
Applicants must be authorized to work in the U.S.