Production Quality Engineer
Full Time. Louisville, CO
Bolder Surgical is seeking a Production Quality Engineer possessing technical judgment and the value of understanding customer focus to support the company. Essential that candidate possesses the ability to drive for results and collaborate on multidisciplinary product development teams from concept to production. Candidate must be versatile and flexible to work within an entrepreneurial environment.
Additionally, this individual should have the ability to:
• Progress from acquiring limited knowledge to developing broad knowledge and skills in a specific practice area.
• Evaluate, select, and apply standard techniques, procedures, and criteria to perform a task or sequence of tasks for conventional projects with few complex features.
• Progress from exercising limited judgment on details of work and application to work demonstrating judgment that leads to conclusions.
• Collaboratively apply and use judgment to determine adaptations in methods.
This position is responsible for performing the following tasks on an assigned task(s) while receiving close supervision on unusual or difficult problems and general review of all aspects of work:
• Collecting data and gathering information for assigned project(s)
• Performing standard computations or analysis.
• Progressing from performing simple to moderately complex design and project tasks while being directed by objective rather than being directed at the task level.
• Preparing portions of project documents. Performing research and investigations.
This position may be assigned tasks to and coordinate with technicians or administrative staff and must possess the following skills to:
· Interact with other staff effectively
· Communicate effectively both orally and written
· Assist with communication to peers and managers pertaining to specific assignments or meetings
• Assistance and back up for Material control management including receiving, receiving inspection, non-conforming materials, and material evaluation and disposition.
• Development and ongoing assistance in management of cleanroom monitoring, sterilization requalification, and product bioburden monitoring programs.
• Assist in quality inspection plan (QIP) development and non-conforming material investigation.
• Assistance in development of calibration and preventive maintenance of receiving inspection equipment.
• Review and approval of production documentation and records, including in-process inspections, QMS updates, rework procedures, change orders, and process validation documentation (MVPs, IQ, OQ, PQ, and pFMEAs.)
• Evaluates customer returns and feedback; communicates results effectively with the customer.
Job Requirements and Qualifications
- Bachelor’s degree in Engineering or scientific degree or the equivalent of education experience sufficient to successfully perform the essential functions of the job may be considered.
- 3-5 years of Quality or Production Engineering experience.
Work Enviornment/Other Information:
· Ability to work flexible hours. Travel for this position is anticipated to be 4-6 times per year to/from contract manufacturers
· The employee is regularly required to sit, stand, walk, and reach with hands and arms, use hands to finger, handle, feel, and be able to talk and hear. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.
Bolder Surgical is a medical device manufacturer based in Louisville, CO that has redefined surgery particularly in small spaces. Founded in 2010, we have developed and are marketing laparoscopic surgical instruments including the world’s smallest low-power 3mm Vessel Sealer & Generator and the world’s first ever 5mm linear Stapler. As the company continues to bring unique, high quality products to market, activities around R&D, quality, regulatory, sales, marketing, and manufacturing are increasing dramatically. The company is well capitalized and is poised for substantial growth through the coming years.