Principal R&D Engineer

Cambridge Recruiters; Sunnyvale (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

Cambridge Recruiters is seeking a senior Medical Device Design Engineer in the Bay Area with 10+ years of medical device experience to lead product development efforts from concept to market release.

The role requires leadership, strong communication, and a solid understanding of GMP/GLP regulatory practices, with a focus on vascular interventional products. You will collaborate with clinicians and engineers across stages of R&D, validation, and product launch.

Qualifications

• 10+ years of medical device design experience in medical/clinical settings.
• 2-3 years of team lead or supervisor experience.
• Must have medical device engineering experience.
• Ideal: vascular interventional products experience (catheters, vascular access devices, guidewires).
• Ability to lead projects from concept to market release.
• Familiarity with regulatory requirements (GMP/GLP) and design controls.
• Strong analytical and communication skills.
• Proficiency with SolidWorks.
• Proficient in MS Word and Excel.

Responsibilities

• Responsible for product development from design to validation of systems and devices.
• Clearly communicates designs and requirements to support personnel both verbally and in writing.
• Works to improve and expand company's capabilities to provide R&D services.
• Develops feasibility plans, cost analyses, design reviews, risk analyses, and verification/test plans.
• Builds and implements a detailed R&D work plan to meet project objectives.
• Develops prototypes and procures equipment; coordinates supplier activities.
• Ensures cross-functional communication across teams and with QM.
• Attends animal studies as needed.
• Collaborates with medical professionals through all stages of product development.

Skills

Team leadership

Problem solving

Communication skills

Pressure handling

Out-of-the-box thinking

Education

BS Mechanical Engineering

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.