Principal R&D Engineer, Fluidics
Campbell, CA
Full Time
R&D
Experienced
Job Title: Principal R&D Engineer, Fluidics
Location: This position is based in our Campbell, California offices.
Why Telos Health?
At Telos Health we are developing novel robotic-assisted technologies and interventional capabilities that will forever change the disparate outcomes of ischemic stroke – a disease that impacts close to a million people a year in the U.S., and 10 million worldwide. Not only is Telos changing the way stroke is treated, but also bringing this treatment to the greater population who is currently without. We are actively building a team who is focused on developing novel solutions for this complex disease – a disease in which one in four adults will face in their lifetime.
What You’ll Do:
We are looking for an energetic and experienced individual for the Telos Engineering team to lead the single use fluidics project activities. We are looking for someone that has experience in medical device disposable life cycle, from early-stage product development all the way through production and market release. In a highly cross-functional engineering team, you will drive the development plan, manage budget, timeline, deliverables and priorities, and report to leadership status of activities. Your will also be responsible to manage and interface with external vendors to ensure their deliverables stay on track with the project timeline. In addition to leading project activities, you should be comfortable providing design input to the Mechanical team and contribute to writing test plans, test protocols and running testing and verification activities. We are looking at someone that can thrive in a very dynamic environment, can make quick and sound project decisions, drive activities to completion, but also identify and solve blocking items that prevent program progress.
If you believe in pushing the boundaries to impact the healthcare industry, be at the cutting-edge medical device technology and help solve the next challenges in stroke intervention, we would love for you to join us in our next endeavour.
Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.
Join Us! Apply today.
Salary Range: $176,000 - 191,000 annually
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.
Location: This position is based in our Campbell, California offices.
Why Telos Health?
At Telos Health we are developing novel robotic-assisted technologies and interventional capabilities that will forever change the disparate outcomes of ischemic stroke – a disease that impacts close to a million people a year in the U.S., and 10 million worldwide. Not only is Telos changing the way stroke is treated, but also bringing this treatment to the greater population who is currently without. We are actively building a team who is focused on developing novel solutions for this complex disease – a disease in which one in four adults will face in their lifetime.
What You’ll Do:
We are looking for an energetic and experienced individual for the Telos Engineering team to lead the single use fluidics project activities. We are looking for someone that has experience in medical device disposable life cycle, from early-stage product development all the way through production and market release. In a highly cross-functional engineering team, you will drive the development plan, manage budget, timeline, deliverables and priorities, and report to leadership status of activities. Your will also be responsible to manage and interface with external vendors to ensure their deliverables stay on track with the project timeline. In addition to leading project activities, you should be comfortable providing design input to the Mechanical team and contribute to writing test plans, test protocols and running testing and verification activities. We are looking at someone that can thrive in a very dynamic environment, can make quick and sound project decisions, drive activities to completion, but also identify and solve blocking items that prevent program progress.
If you believe in pushing the boundaries to impact the healthcare industry, be at the cutting-edge medical device technology and help solve the next challenges in stroke intervention, we would love for you to join us in our next endeavour.
- Lead development, testing and verification activities of single use medical devices components in compliance with internal design control SOPs
- Oversea a team of cross functional engineers in a matrix organization
- Collaborate with cross-functional teams and leading clinician on feature specifications and requirements, and make decisions about implementation and resource trade-offs
- Collaborate closely with R&D, QA, Clinical Engineering, Program Management, Operations, and Product to ensure successful design, testing and release of the product.
- Collaborate with the Mechanical team to provide and review design solutions
- Manage project activities, budget, timeline, deliverables, priorities and identify bottlenecks
- Communicate project status to escalate issues to high-level management, users, and staff
- Manage multiple external vendors and contract manufacturers for development, testing and manufacturing activities.
- Work with QA team to create a verification plan and drive risk control assessment
- Participate in the testing and verification activities such as protocol development, and protocol execution for subcomponents testing, system integration and system testing.
- Ensure that product releases successfully meet user needs and that key performance indicators for product performance are defined and met
- Ensure product complies to medical device regulations and standards
- Participate in the preparation of technical documents for FDA submissions
- Strong analytical and problem-solving skills with knowledge of technical alternatives and their impact to project deliverables
- Effective engagement with cross functional teams and key stakeholders to influence outcomes and achieve project objectives
- 8+ years of industry experience with a BS/MS in Mechanical engineering, Biomedical engineering, or related field.
- 5+ years of industry experience developing medical devices or healthcare products, specifically single use, disposable components.
- A solid understanding of design control requirements (21CFR820).
- A history in bringing single use medical products from prototyping to production release.
- Strong understanding of fabrication methods including machining, rapid prototyping, and injection molding.
- Strong understanding of sterilization validation, biocompatibility testing, aging testing and verification testing.
- Experience with fluidics systems and subsystems and their interaction and interface with capital hardware and other single use disposables a plus.
- Previous experience managing outside contract manufacturers.
- Hands-on engineering experience with the proven ability to work well within highly cross-functional team from multiple disciplines.
- Previous experience with the development of budgets, project plans, etc.
- Excellent presentation skills are required
- Excellent communications skills (both written and verbal) required
Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.
Join Us! Apply today.
Salary Range: $176,000 - 191,000 annually
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.
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