This position will be responsible for manufacturing engineering and production line support associated with the delivery system for a biodegradable implant developed for a soft tissue orthopedic application. Key duties include development of manufacturing and inspection procedures, design and development of appropriate assembly tools and fixtures and ongoing manufacturing line support. All development will be in close cooperation with design engineers. Methods and output must be compliant with the quality system and applicable medical device regulations. Initial work will be small scale and targeted at achieving capability to support verification and validation followed by First in Human clinical trials. Subsequent focus will be scale up and cost reduction for pivotal clinical trials and commercialization.
- Provide technical leadership for medical device manufacturing assembly
- Create manufacturing and inspection procedures
- Train production assembly operators
- Design and develop assembly tools and fixtures
- Schedule builds and assure component inventory to achieve program objectives
- Support manufacturing activities to achieve design verification and validation
- Assure manufacturing capability appropriate for First in Human clinical trials
- Support supplier development activities
- Partner with development engineers to drive capability and cost reductions for subsequent scale up through design, manufacturing and supplier modifications and enhancements
- BS in Mechanical or Biomechanical Engineering
- 5+ years experience in medical device Manufacturing Engineering in a cleanroom environment
- Demonstrated ability to team with design engineers in creative problem solving
- Ability to be “hands on” in design and fabrication of fixturing using Solidworks
- Knowledge of and familiarity with applicable suppliers
- Respect for and an understanding of the need for getting things done
While performing the duties of this job, the employee is occasionally required to stand; walk; and/or sit 8 hours each day. The employee must occasionally lift and/or move up to 25 pounds.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Contact: Please send resume and cover letter with salary expectations.
No relocation assistance is available. Candidates must already have authorization to work in the U.S. Resumes submitted by staffing agencies and/or recruiters will not be accepted.