Mechanical/Optical Engineering Position at OCT Medical Imaging Inc.
This opening is for a senior mechanical engineer who will be responsible for the design and development and manufacturing of several intravascular catheters and pullback devices used in intravascular imaging. Senior mechanical engineer will develop disposable devices following FDA regulatory standards, by working in coordination with regulatory professionals, optical engineers and software professionals in the company. Moreover, senior mechanical engineer will, maintain history files of product designs, and make changes by working in close coordination with end-users as needed. This position requires a bachelor’s degree in mechanical engineering with 10 years’ experience in medical device industry or a master’s degree in mechanical engineering with at least 5 years’ experience in a medical device company or PhD with three years of experience in developing disposable catheter and related products. Prior experiences in OCT or intravascular ultrasound (IVUS) devices will be a plus.
Major Job responsibilities:
- Product design and development for intravascular imaging including OCT catheter and guidewires
- Design and development and optimization of Pull-back devices
- Document and maintain records of product designs
- Interface with other hardware and software engineers during testing and development phase
- Develop design verification testing protocols, perform the required testing and write final reports
- Experience in Finite Element modeling and Solidworks
- Use computer aided design (CAD) software to develop and test product designs
- Coordinate with engineers and regulatory personnel and clinicians during all aspects of product development until FDA approval
- Work with other hardware engineers to develop related peripheral componentsEducation
- Bachelor or master’s degree or PhD in Mechanical engineering/Optical or equivalent.
Skills & Experience
Experience & Training:
- Two to ten years of relevant catheters and related products development and engineering experience is a must.
- Project management experience is a plus.
- Proficiency with CAD software such as Solidworks.
- Knowledge of FDA required product design history file maintenance is desirable.
- Working Knowledge of IVUS and OCT catheters are a plus
- Knowledge of OCT and optical design and simulation software such as Zemax is a plus
- Knowledge of Ultrasound and optical Coherence Tomography imaging is a big plus
- Good understanding of fabrication and manufacturing process (injection molding, machining, stamping etc.,).
- Ability to work with cross-functional teams to complete all associated tasks needed for FDA device approval.
- Mastery of working within formal design control processes, writing test protocols and reports.
- Excellent communication and organizational skills.
- Proven capabilities in root cause analysis and risk assessment processes
- Expected to be self-directed and exercise good judgment in achieving the product development goals
Company Description: OCT Medical Imaging Inc. (OCTMI), is a medical device company developing variety of diagnostic devices for imaging in body channels for a variety of disease states including intravascular imaging. OCTMI provides a conducive startup environment that nurture creativity, team work and provides an opportunity to be part of a team that develops cutting edge technologies in detecting and diagnosing various diseases. We provide, vacation, matching 401k insurance of health, dental and vision.
Please Apply to : firstname.lastname@example.org