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Development Engineer II

 

Development Engineer II

 Research & Development                 ·                  US-PA-King of Prussia                   ·            Full time

 

Development Engineer II

Job Location: US-PA-King of Prussia

 

Job Post Information

Posted Date: February 8, 2024 11:42 PM

ID: 2024-4388

Category: Research & Development

 

About Nevro

Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy™, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 100,000 patients globally.

Nevro’s comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic trunk and limb pain and painful diabetic neuropathy.  Senza®, Senza II®, Senza Omnia™, and Senza HFX iQ™ are the only SCS systems that deliver Nevro’s proprietary 10 kHz Therapy. HFX iQ, Nevro’s latest innovation, is the first and only SCS System that uses Artificial Intelligence to optimize and maintain pain relief using each patient’s response1.Nevro’s unique support services provide every patient with an HFX Coach™ throughout their pain relief journey and every physician with HFX Cloud™ insights for enhanced patient and practice management. 

Nevro also recently added a minimally invasive treatment option for patients suffering from chronic sacroiliac joint (“SI joint”) pain and now provides the most comprehensive portfolio of products in the SI joint fusion space, designed to meet the preferences of physicians and varying patient needs in order to improve outcomes and quality of life for patients.

 

Job Summary & Responsibilities

This position plays a key role in the development of the next generation of Class III implantable Neuromodulation system for pain management or the next generation of Class I tools or implants for Sacroiliac Joint pain. This is a technical position that reports to a Senior Engineer.

As a member of a small team for SI Joint pain, this role may require work as assigned and needed by Quality and Manufacturing Engineering.

  • Display ability to lead small-scale projects from initiation to regulatory submission.
  • Perform tasks required in medical device product development – for implanted devices as well as for external components, tools, and accessories.
  • Establish product requirements and specifications
  • Participate actively with Marketing and Sales to define customer needs. Engage surgeons and KOL throughout the conceptualization and development phases.
  • Led development sessions and actively participate in cadaver labs with surgeons to obtain critical project input. Provide technical feedback on the development of marketing materials.
  • Participate in risk management activities (e.g. dFMEA, pFMEA) and lead design activities such as Design Input, Design Output, Design Verification, Design Validation, and Design Transfer (Ex. Mechanical Testing, Cadaver Lab, etc.)
  • Update & review product CAD models and drawings and participate in Design Reviews.
  • Interfaces with external vendors to develop prototypes
  • Designs, runs, and gathers data for experiments
  • Analyzes and documents test results in a laboratory notebook or equivalent
  • Participates in the design of new test methods and procedures
  • Responsible for processing ECOs and other documentation in compliance with FDA guidelines and ISO requirements
  • Supports laboratory and clinical research
  • Prepares reports and presentations and documents progress with Senior Management
  • Interface with other departments such as Marketing, Manufacturing, Regulatory and Quality.
  • Communicates with physicians and other clinicians on product design and development activities and gathers feedback on product prototypes
  • Investigate and solve mechanical product failure modes and devise solutions to problems
  • Understands and can operate within a highly regulated environment following industry technical and test standards as well as good documentation and laboratory practices.
  • Performs other related duties as assigned

 

Role Requirements

  • Bachelors degree in Engineering (ME, Biomedical). Advanced degrees (M.S. or Ph. D.) are preferred
  • A minimum of 3 years’ experience with at least 1 year in medical devices or other regulated industry such as Aerospace or Automotive.

 

Skills and Knowledge

  • Good analytical and problem-solving skills
  • Ingenuity and ability to innovate clever solutions to problems
  • Strong theoretical knowledge in areas such as tolerance stack-up, solid modeling and design, GD&T
  • Experience in FEA, fatigue testing, and biomedical materials are desirable
  • The following experiences are desirable:
  •  Manufacturing techniques such as plastic injection molding, machining, casting, 3D printing and joining techniques such as welding
  • Human factor considerations of worn textile, mechanical retention (i.e. clips, sleeves, etc) or surgical tools product features.
  • Managing packaging and labeling requirements, testing and documentation
  • Excellent oral and written communication along with good presentation and technical writing skills
  • Knowledge of medical device quality assurance
  • Ability to thrive in a fast-paced, multidisciplinary environment
  • Able to work independently with minimal supervision.
  • Requires the ability to travel approximately 10% of the time throughout the United States and internationally.

 

Target Pay Range

$75,061 – $103,209. The final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, alignment with market data, and geography. *Nevro is a multi-state employer, so the target pay range may increase or decrease depending on the city/state.

Full-time Nevro team members enjoy a full suite of additional benefits such as market-leading medical, dental, and vision benefits, 401k matching, ample vacation time, pre-tax savings perks, tuition reimbursement, Employee Stock Purchase Plan (ESPP), short and/or long-term incentive opportunities, recognition awards, volunteer time off, and several employee resource groups that focus on supporting our Wellness, Leadership Development, and Diversity and Inclusion.

 

EEO Statement

Nevro offers equal employment opportunity, regardless of race, color, creed, religion, national origin, marital or family status, sex, sexual orientation, gender expression (including religious dress and grooming practices), gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), physical or mental condition, protected veteran status, disability, age or other characteristics protected by laws.

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