Principal R&D Engineer

Cambridge Recruiters; Sunnyvale (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

A leading staffing firm is seeking a seasoned medical device engineer in Sunnyvale, California. The ideal candidate will possess over 10 years of experience in medical design, particularly with vascular interventional products. This role involves overseeing product development from concept to market release, collaborating with medical professionals during clinical testing, and ensuring compliance with regulatory requirements. Strong communication and leadership capabilities are essential for success in this position. Local candidates are strongly preferred.

Qualifications

• 10+ years medical design experience in a medical device/clinical environment.
• 2-3 years of team lead or supervisor experience.
• Ideal experience with vascular interventional medical products.
• MUST HAVE: Medical Device Engineering experience.
• Ideal Product Experience: vascular interventional products, catheters, vascular access devices and guidewires.
• Ability to lead projects from concept through market release.
• Knowledge of regulatory requirements including GMP/GLP.
• Strong analytical and communications skills.
• Out-of-the-box thinking and drive for excellence.
• Proficiency with SolidWorks/CAD and MS Word/Excel.

Responsibilities

• Responsible for product development activities and validation of systems.
• Collaborate with medical professionals for prototype development.
• Ensure communication processes are established across groups.
• Develop marketing and engineering specs, feasibility studies, cost analyses and risk assessments.
• Build and implement a detailed R&D work plan to meet project objectives.
• Develop prototypes and coordinate supplier activities.
• Ensure cross-functional communication across teams.
• Communicate quality management system information.
• Attend animal studies as needed.
• Collaborate with medical professionals through all development stages.

Skills

Medical Device Engineering experience

Strong analytical skills

Communication skills

Out-of-the-box thinking

Proficiency with SolidWorks/CAD

Basic MS Word and Excel

Education

BS Mechanical Engineering or similar engineering discipline

Tools

SolidWorks

CAD

MS Word

MS Excel

Job description

• Responsible for product development activities that encompass the design, testing, fabrication and validation of systems and devices as well as ancillary systems that may be necessary to meet company goals and objectives.

Description

• Applies intensive and diversified knowledge of engineering principles and practices to the research, development, design and evaluation of technical suitability of materials, components, assemblies, processes and/or equipment. Clearly communicates designs and all requisite requirements to support personnel both verbally and in writing.
• Works to improve and expand company's capabilities to provide R&D services
• Contributes to, develops and/or performs marketing and engineering specifications, feasibility plans/studies/reports, cost estimation/analysis, design reviews, risk and hazard analyses, FMEAs for Design/Process/Use, product verification and validation testing.
• Builds and implements a detailed research/development work plan to fulfill company's project objectives.
• Develops prototypes and processes based on company's available equipment, processes and/or specifies, procures suitable equipment for development reviews or coordinates supplier activities to support development.
• Ensures appropriate communication processes are established within and across functional groups.
• Communicates information related to quality management system effectiveness.
• Attend animal studies as needed.
• Collaborates with medical professionals to during all stages of development of prototypes/products including market/product specification development, pre-clinical and clinical testing of prototypes/products.

Training and Experience Required

• BS Mechanical Engineering preferred, or similar engineering discipline.
• 10+ years medical design experience in medical device/clinical environment.
• 2-3 years of team lead or supervisor experience.
• MUST HAVE: Medical Device Engineering experience
• Ideal Product Experience: Vascular interventional medical products and technologies, especially catheters, vascular access devices and guidewires.
• Ability to Function as the Project Leader from the Concept Phase through Market Release.
• Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other employees and supervisor.
• Ability to attend human clinical cases and interact the hospital staff in a constructive and professional manner.
• Knowledge of medical device industry regulatory requirements including design and control practices, GMP’s and GLP’s.
• Strong analytical and communications skills.
• Out-of-the-box thinking, creativity and drive for excellence.
• Proficiency with SolidWorks/CAD
• Proficient at basic MS word and Excel.

Local Candidates strongly preferred

NO H1B or C2C candidates. The client will NOT provide sponsorship or H1B Transfers.