Staff R&D Engineer, Devices

Imperative Care; Campbell (CA); On-site; USD 160,000 - 185,000; Full time

Benefits offered by this job

Stock options

Bonus

401k plan

Health benefits

Generous PTO

Parental leave

Job summary

Imperative Care in Campbell, California, seeks a Staff R&D Engineer, Devices for on-site, full-time work with some travel. Based in our Campbell office, you will lead the design and validation of interventional neurovascular and vascular medical devices from concept through commercialization.

You will create designs using CAD (SolidWorks), supervise prototyping, bench testing, and validation activities, and collaborate with cross-functional teams and contract manufacturers to optimize

Qualifications

• Bachelor’s degree in engineering and 8+ years of device development experience.
• Strong background in intravascular device design and manufacturing controls.
• Experience with design verification and test method validation.
• Ability to travel domestically and internationally.
• Knowledge of polymers, stainless steel, nitinol materials.

Responsibilities

• Lead design efforts to ensure safety, reliability, and performance of new devices.
• Define product requirements with cross-functional teams and lead prototyping and testing.
• Collaborate with contract manufacturers to scale production and ensure quality.

Skills

Medical device design

Design verification & testing

Prototype development

CAD SolidWorks

Cross-functional collaboration

Regulatory compliance knowledge

Travel flexibility

Education

Bachelor's degree in engineering

Tools

Centerless grinding

CNC Swiss

Laser micromachining

Precision machining

Job description

Title: Staff R&D Engineer, Devices

Location: This position is based in our Campbell, California offices. This position is on-site and full-time with some travel.

Why Imperative Care?

Do you want to make a real impact on patients? Imperative Care is changing the way stroke and vascular diseases are 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

This role is for a hands-on, individual contributor to lead technical innovation, design, development, manufacturability, and testing/verification/validation of new medical devices, including specialty devices used in the interventional neurovascular and vascular markets from early stage through commercial release and transfer to manufacturing according to established Design Control procedures.

• Work closely with Marketing, Clinical Engineering, and physician partners to define product requirements, create designs using CAD software (Solidworks), and lead prototyping and bench and other preclinical testing and experiments to ensure product performance, reliability, and safety.
• Collaborate cross-functionally with Process Development, Quality, Regulatory, Marketing, and Mfg/Ops teams within Imperative Care and contract manufacturer(s) to ensure new product manufacturability (DFM) and robust process control and alignment with design specifications, quality systems, operational capabilities, and cost targets and to optimize and scale existing processes to improve efficiency, yield, and product quality, working with outside partners as needed.
• Support and work collaboratively with contract manufacturing partners for the design, implementation, and validation of the related manufacturing equipment and processes needed for scalable, high-accuracy medical device production.

What You’ll Bring

• Bachelor’s degree in engineering, or related discipline and a minimum of 8+ years of related experience driving innovation in the development of flexible medical device instruments; or equivalent combination of education and work experience in related regulated industry.
• The ideal candidate will have a strong background in intravascular medical device design, development, prototyping, executing design verification and test method validations, and manufacturing methods and controls, with a focus on guidewires, stents, stent delivery devices, catheters, and/or similar devices.
• Familiarity with special-purpose machine design, automation, precision machining (e.g., centerless grinding and CNC Swiss and laser micromachining), equipment and manufacturing methods used for device fabrication, as well as process development and validation within a regulated manufacturing environment to support activities both in-house and in collaboration with contract manufacturer(s).
• Experience with advanced materials such as polymers, stainless steel, platinum, hydrophilic coatings, and nitinol, as well as related precision fabrication and processing/machining techniques (e.g., tube drawing, coil winding, braiding, laser processing, grinding, EDM, CNC).
• Must be able to travel domestically and internationally, as necessary.

Employee Benefits

• 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.

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 considerations when extending an offer.

The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.

Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.