Research And Development Engineer

Title: Principal Engineer / R&D Engineer

Duration: 6 months contract with the possibility of extension

Location: Santa Clara CA 95050

Shift: 9am-5pm PST

Must Have:

• CAD Experience
• Self Sufficient Contractor- This is not entry level position
• Minimum of 7 years of experience of Medical Device experience
• Working Knowledge of Design Control

Good Haves:

• Catheter experience

This position is primarily focused on R&D and product development activities, not manufacturing operations.

Job Description Summary:

• This engineering position requires strong technical and time management skills to support the design and development of innovative, new products within the Vascular Closure Group.
• The Principal Engineer will apply advanced technical principles, theories, and concepts related to new product introduction and research and development projects.
• This individual will work closely with cross functional teams to ensure products are launched on time and in compliance with internal SOP, FDA and international regulations.
• This Product Development Engineer will be responsible for acting as the lead design engineer on Disposables R&D projects.

Day to Day: managing project timelines and deadlines, coordinating with the project manager, creating samples for marketing and manufacturing, spending a significant amount of time doing hands-on lab work, attending meetings and one-on-ones as needed, preparing test reports, and developing presentations for senior leadership. The role is fairly self-paced, but the engineer is responsible for making sure the project continues moving forward at the expected pace.

Essential Duties and Responsibilities:

• Lead R&D efforts relating to product sustaining and life-cycle management for Client Disposable products, including CAPAs, SCNs, and Design-related initiatives and programs.
• Hands-on device testing, troubleshooting, prototype development as well as lab equipment maintenance.
• Provide technical and project leadership directing initiatives of varying size, scope, and complexity with effective management of project Scope, Time, Budget, and Communication.
• Work closely with cross-functional teams such as Manufacturing, Regulatory and Quality, to take a product from concept to commercialization.
• Utilize advanced experimental design methodologies, with significant complexity, and execute test protocols and reports to facilitate the design of medical devices.
• Develop clinically relevant bench top test models and methods for device performance evaluation.
• May be involved in product preclinical testing to investigate product performance.
• Analyze data using advanced statistical techniques and communicate results to a cross-functional team.
• Responsible for managing design control activities to ensure deliverables are made in compliance with internal SOPs, FDA and international regulatory regulations.

Qualifications:

• Experience with IQ/OQ of lab equipment and maintenance of PM and Calibration.
• Experience in device testing, troubleshooting, and prototype development.
• Experience with product concept development, customer interaction, and validation of customer needs/design requirements.
• Working knowledge of Medical Device Design Control including active management of Design History File elements and quality system requirements.
• Advanced Working knowledge of CAD (Solidworks) and fixture design.
• Working knowledge of statistical study designs (DOE, ANOVA, etc.) for feasibility and design verification of disposables.
• Understanding and experience in design, development, and testing of cardiovascular catheter delivery systems, or equivalent devices is a plus.
• Familiarity with good manufacturing processes (GMP), QMS, and domestic and international regulatory agencies requirements.
• Experience with high volume production environment is preferred.
• Experience with IDE, PMA and Class III device classification is preferred.
• Familiarity with AGILE is a plus.

Education and Experience:

• Bachelor’s degree in technical concentration (Mechanical or Manufacturing Engineering, Bioengineering, Industrial Engineering, etc.) is preferred.
• Minimum of 7 years of experience in the medical device industry.

Skills:

• Displays solid written and verbal communication and presentation skills, and effectively communicates with customers, multiple teams and diverse stakeholders across the company.
• Independent thinker with team-oriented mindset.
• Ability to identify critical path and mitigate risk as early as possible.
• Possess good mechanical aptitude to assist in design and problem resolution.

EEO: “Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”