Sr. Design Engineer
Acist Medical Systems, Inc. - Fremont, CA

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ACIST Medical Systems is the market leader in providing innovative diagnostic and therapeutic products and services that enable interventionalists and their clinical teams in providing superior patient care. Our focus is “the pursuit of the perfect image” through continuous research and development of new products and technologies – supporting today’s needs and anticipate those of tomorrow. We are an international company, with products in over 45 countries, providing high quality systems and award-winning customer support across the globe.

We believe employees are our greatest asset. ACIST fosters an environment that attracts and retains employees who are proactive, responsive and innovative through commitment to teamwork, communication, feedback and change.

Position Summary:
Provide expertise in the area of electromechanical and catheter design. Frequently act as a leader during product development and process improvement initiatives. Primary responsibilities include device design prototype generation, testing and evaluation, and technical problem solving from concept through market release. The individual will also be expected to provide project and technical leadership to project teams.

Primary Duties and Responsibilities:
Projects – Product and Technology Development

Develop ACIST’s catheter technology

Integrate and transfer emerging and existing technologies and materials into ACIST’s catheter technology capabilities

Ensure the success of multiple prototyping and product-development activities that leverage ACIST’s emerging catheter technologies

Design, prototype, and construct innovative catheter-based delivery systems, stand-alone catheter products, and related interventional devices

Stay current with the portfolio of ACIST’s catheter designs and incorporate best practices and applicable standardization in the development of new designs

Deliver design packages that include initial specifications, preliminary procedures, material sets, test methods, suppliers, and summary of work done along with early prototype systems

Drive toward an essential understanding of capabilities and materials used in ACIST’s catheter systems and share this understanding to promote the use of the proper tools

Integrate state-of-the-art industry technologies and ACIST’s technologies into the ACIST’s catheter technology portfolio through innovative catheter designs

Nurture technology transfer between ongoing catheter development projects and allied technology efforts throughout ACIST’s operations

Create and assess the feasibility of catheter system and/or technology options for downstream development partners, including development of accurate in vitro and in vivo test plans, models, and methods

Collaborate with outside vendors on the outsourcing of catheter materials and components

Perform competitive intellectual-property analyses and cultivate an intellectual-property portfolio of catheter-related technologies

Support

Contribute to regulatory submissions

Review technical aspects of catheter-related projects as required by ACIST’s quality system

Technical Documentation and Training

Generate Change Orders (CO) to document design and manufacturing process instructions (MPI).

Generate Test Plan(s) (TP), Test Report(s) (TR) Work Instruction(s) (WI), and Non conforming reports (NCR)

Train technicians and/or operators on processes

Required Skills

Minimum:
Bachelor's degree in mechanical or materials engineering

6 years experience as a design engineer/mechanical engineer with catheter design experience

Proven history of catheter design experience, including:
Managing technology and/or design projects

Contributing as part of a small team

Demonstrated mechanical aptitude

Proficient use of Microsoft Office

Proficient use of Solidworks

Statistical Software, (exp. Design of Experiment (DOE), Gauge R&R, T-test, and SPC)

Strong verbal and written communication skills and interpersonal skills to effectively translate ideas, concepts and information

Adaptable, team-oriented working style

Demonstrated record of self-motivated performance

Proven ability to identify, initiate, and drive tasks and projects to completion

Demonstrated ability to maintain flexibility with regard to projects and changing priorities

Proficient technical writing skills

Preferred:
Experience in/with:
Working as a member of a small team

Collaborating with team-members across disciplines

Minimally invasive intravascular devices

Knowledge of and experience with:
ISO requirements

Foreign and domestic regulatory submission procedures

GMP guidelines

Medical-device design control

R&D development cycles

Enthusiastic attitude toward catheter design, allowing for creative problem solving and efficient idea sharing

Creativity

Required Experience

About this company
ACIST® Medical Systems is a global medical device company that develops advanced contrast injection technologies that help simplify the...