Salary Range:

$143,250.00 - $238,750.00

Job Description:

Confluent Medical Technologies is a financially healthy and rapidly growing medical device company whose employees are passionate about providing life-saving solutions to our customers through a collaborative and high-impact work environment.  Our moderate size, diversity of technologies, and broad material science capabilities provide an environment in which our employees can develop broad skill sets and directly influence product development and manufacturing outcomes.

We are seeking a Nitinol Components Product Development Engineer to join our talented team in Fremont, California.  This valued team member will be responsible for designing and optimizing Nitinol components and subassemblies for a variety of medical applications; development of process parameters and fine tuning of specific outputs to ensure the product meets specification.  The Nitinol Components Product Development Engineer will participate in the execution of New Product Development projects, regardless of scale, specifically focused on Nitinol medical devices and will execute the successful transfer of new products through all phases of the development cycle to volume production.

Responsibilities:

• Responsible for new product development process identification, parameter optimization, proof of concept testing, technology improvements, and process implementation.   
• Responsible for tool and fixture design and qualification used for manufacturing medical devices and components. Must be able to accomplish broad and complex assignments.  May provide technical guidance to lower level personnel.
• Responsible for screening and optimization of process parameters to achieve robust and stable processes and maximize yields, efficiencies and process capabilities.   
• Plan and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria.
• Design and perform process characterization studies & DOE’s, support protocols and reports.  
• Have a firm understanding of validation strategy (IQ/OQ/PQ), support protocols and reports. 
• Works on problems and projects of moderate to complex scope where analysis of situation or data requires a review of identifiable factors.  Selects techniques to solve complex problems and make sound engineering recommendations.
• Generate clear and concise work instructions, test methods, and visual standards.     
  • Adhere to all company quality policies and procedures.
  • Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
  • Mentor less experienced engineers/technicians.   

Essential Qualities:

• Ability to read, interpret, and update drawings for complex mechanical devices and assemblies.
• Understanding of GD&T and tolerance stack analysis.
• Ability to solve complex technical challenges by applying materials science and fundamental metallurgical principles.
• Understanding of materials science and fundamental metallurgical principles. Hands-on experience with Nitinol alloys required.
• Capable of performing under multiple competing deadlines while maintaining a cooperative and constructive working relationship with colleagues. 
• When complex technical problems are encountered, provides guidance to the team on how to address and resolve the issues. 
• Has in depth knowledge of line of work in addition to being a recognized expert within the company in specific area. Keeps up to date of developments affecting his/her areas of expertise to ensure the organization remains current with the technology.  
• Ability to communicate clearly and efficiently in a highly technical environment.
• Able to work independently with minimal supervision.

 Education and Experience:

• Experience working with Nitinol technology and testing required.
• Bachelors in Engineering with a minimum of 12 years of related hands-on engineering experience in the medical device field OR a Masters degree in Engineering and a minimum of 10 years of engineering experience OR PhD in Engineering with a minimum of 8 years of related engineering experience.  Degree in Mechanical or Materials Science Engineering preferred.  
• Experience designing high precision mechanical components.
• Strong Solidworks modeling and drawing experience.
• Experience with Minitab or JMP desirable.
• Familiarity with metalworking/machining processes.
• Strong communication skills, written and oral. Able to communicate complex technical concepts clearly and effect.   
• Familiar with technical terms, regulations and standard practices (ISO, ASTM, FDA, etc.) related to field of work.   
• Proficient in MS Word / MS Excel / MS Office   

Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components and tubing, balloon expandable stents and catheters, complex catheters, biomedical textiles, and high precision polymer tubing. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.

We regret that we are unable to sponsor employment visas or consider individuals on time-limited visa status for this position.

Confluent Medical Technologies is an equal opportunity employer.

Only qualified candidates will be contacted.