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Staff R&D Engineer
Job Title: Staff R&D Engineer
Location: This position is based in our Campbell, California offices. This position is onsite and full time.
Why Imperative Care?
Do you want to make a real impact on patients? Imperative Care is changing the way stroke is treated. As part of our team, you’d be developing breakthroughs that will revolutionize the future of stroke care. Every day, the technologies that we develop at Imperative Care directly impact human lives. Our focus is on the needs of the patient, and they come first in everything we do.
What You’ll Do
As an advanced professional in this field, the Staff R&D Engineer is responsible for conceptualization, design, development, and manufacturability of endovascular/neurovascular new products along with improvements to current product features. This position uses advanced expertise and deep technical knowledge to design innovative new products and solutions that advance product development initiatives in one of the specific engineering focuses mentioned below. This role determines best course of action to solve complex situations and serves as the R&D lead on cross-functional project teams, mentoring other junior R&D engineers to contribute to their development.
- Lead technical design and development of products from early prototyping to manufacturing transfer.
- Drive innovation and ensure products achieve best-in-class performance while promoting manufacturability and meeting cost targets.
- Use advanced expertise to work directly with customer representatives, marketing, physicians, pre-clinical engineering, and regulatory affairs to understand user interactions, identify product opportunities, and develop comprehensive product requirements.
- Conduct animal, cadaver, and/or bench top studies to systematically evaluate and/or characterize product performance dependencies and usability needs.
- Lead design-focused risk analysis activities, product verification and validation test planning, and oversee product test development and execution.
- Research and advise on new vendors, materials, and/or processes.
- Play a key technical role in a project team, evaluating assigning appropriate R&D engineering resources to meet project milestones.
- Lead cross-functional project team to ensure products are designed, developed, and manufactured in compliance with customer needs, company quality systems, budget, schedule and regulatory requirements of the countries into which the products will be marketed.
- Oversee that technical activities are properly documented and work together with process development to create manufacturing processes for a successful product transfer to manufacturing.
What You’ll Bring
- Bachelor’s degree in engineering, or related discipline and a minimum of 8 years of related experience developing flexible medical device instruments; or equivalent combination of education and work experience in related regulated industry.
- MS in Engineering and experience in medical device development in a start-up environment preferred.
- Statistical analysis Software (Minitab or similar) and CAD (Solidworks, ProE, similar).
- Demonstrated knowledge of and exposure to product testing and data collection.
- High level of expertise with Product Lifecycle Management from proof of concept through manufacturing transfer including documentation control systems and design.
- Experience working under quality systems designed to meet governmental regulations such as FDA, GMPs, QSR, ISO 13485/9001, and the MDD.
- Experience leading a technical cross-functional team through all phases of product development. Strong understanding of braiding, laminating, coiling, and laser cutting design and process constraints.
- Ability to be self-directed with minimal direction and supervision and take initiative to discern from multiple priorities when guiding a technical project team toward efficient solutions and opportunities; ability to multi-task efficiently in a fast-paced environment.
- Entrepreneurial spirit, a strong foundation in documentation and communications skills required.
Employee Benefits include a stake in our collective success with stock options, bonus, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.
Join Us! Apply Today.
Salary Range: $160,000 - 185,000 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 consider
