Sr. Clinical Research Engineer
About The Position
The Senior Clinical Research Engineer, Future Forward, leads the design and development of new product concepts before commercial launch, applying clinical, scientific, and technical expertise. The role works closely with engineers, physicians, interaction designers, human factors specialists, training and technical publication specialists, and internal and external stakeholders to guide product and procedure development. It supports early-stage feasibility studies, gathers case insights, identifies and documents user needs, manages product requirements and clinical risks, and provides clinical design guidance. The role develops and executes pre-clinical and clinical evaluation strategies to assess device performance, safety, and usability throughout the Product Development Process and prepare technologies for commercial launch. It also partners with regulatory, quality, clinical affairs, finance, and other cross-functional teams on clinical indications and commercialization strategies, advancing technology from concept to a commercial-ready product.
Requirements
- Fluent in medical procedure terminology and sound knowledge of anatomy.
- Ability to understand complex robotic systems and software algorithms.
- Experience working in an operating room or interventional suite environment.
- Experience collaborating with physicians and collecting feedback on clinical product use.
- Excellent mechanical and technical aptitude, including spatial relations and understanding complex mechanical products.
- Excellent analytical capability and practical skills to develop and test clinical hypotheses and draw succinct conclusions.
- Strong teamwork skills and demonstrated ability to foster collaboration across disciplines to support timely project success.
- Demonstrated success recognizing critical issues and driving them to closure through coordinated action.
- Experience with product development and Design Controls.
- Effective verbal, written, and presentation communication skills.
- Self-starter who requires minimal supervision.
- Self-confident and able to react quickly under pressure.
- Minimum B.S. in Biomedical Engineering, Mechanical Engineering, or a similar field.
- At least 8 years of related experience in clinical engineering and/or product development within the medical device industry.
- Must be available to work full-time and commute or relocate to Sunnyvale, California.
- Available for up to 30% travel, including some international travel.
Nice To Haves
- Experience with on-site clinical trial support.
- Experience with commercial product launch.
- Familiarity with intellectual property development and patent assessment.
Responsibilities
- Lead the design and development of new product concepts prior to commercial launch.
- Research disease states and medical technologies related to new business opportunities and develop expertise in new products and their clinical applications.
- Collaborate with marketing partners and clinicians to identify and understand marketing needs.
- Work with key opinion leaders, subject matter experts, and other stakeholders to identify clinical goals and translate needs into user-centric designs for platforms, procedures, instruments, and accessories.
- Collaborate with engineers and physicians to define and evaluate clinical performance goals and potential safety and usability risks for products in early-phase development.
- Develop and execute clinical derisking pathways, including pre-clinical and clinical feasibility studies.
- Assess product design iterations internally and with external key opinion leaders.
- Develop and execute preclinical evaluation strategies in advance of human trials and regulatory submissions.
- Provide subject matter expertise for user manuals and training documentation.
- Support regulatory documentation and submissions.
- Identify potential product enhancements and new product ideas using an analytical approach.
- Lead and execute early-stage feasibility studies, pilot trials, and pivotal clinical trials supporting technology development and regulatory and reimbursement strategies.
- Collect and analyze clinical study insights to inform product requirements and training needs, and manage clinical risks in accordance with quality management systems.
- Design, develop, and execute clinical evaluations of prototypes, translating feedback for engineering teams.
- Develop intellectual property for novel clinical applications and technologies.
- Keep the organization’s vision and values at the forefront of decisions and actions.
- Perform other duties as required to support the company’s strategy and goals.
Benefits
- Market-competitive compensation package including base pay, incentives, benefits, and equity.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
