The engineer is to work within a regulated quality system environment to further develop Moximed's joint unloading technology embodied by the MISHA Knee System. In this role you will be working with cross-functional groups. Your role will be essential in developing product improvements and verifying/validating changes against user needs, product requirements, and intended use. Must enjoy the team approach over individual contributions. Experience with product development after design transfer to production is required.
Responsibilities
Build on current product and joint unloading technology following design control procedures and principles.
Analyze and interpret customer feedback, complaints, and retrieved products to drive and support product development activities.
Collect data to support the business case and design input for development projects. This includes root cause analysis, cost estimates from suppliers, and one-on-one or focus group meetings with end-users including surgeons, nurses, and other healthcare workers. The ability to assist with COGS assessments is desirable.
Integrate cross-functional groups early in the development and provide consistent updates.
Create and perform engineering validations and verifications - challenge existing tolerances, mechanical testing, packaging testing, etc.
Perform risk-based assessments as part of development activities. Experience with developing and executing biocompatibility evaluation plans to support product and process changes is highly sought.
Prepare and present technical and end-of-phase design reviews to cross-functional group members.
Maintain accurate documentation including test protocols, reports, and engineering assessment to support quality system and regulatory requirements. Incorporation of lean documentation principles required.
Suggest, contribute, and champion initiatives to improve R&D, design control, and change control practices.
Work directly with cadavers and in an OR setting to inform on the development and refinement of hand-held surgical instruments and minimally invasive surgical techniques.
May require up to 10% travel to visit suppliers, end-users, etc. in addition to working on site in the Fremont facility as needed.
Other responsibilities may be assigned to meet the needs of Moximed.
JOB REQUIREMENTS
Education and Training
Bachelor's Degree in mechanical engineering or equivalent discipline preferred.
5+ years of experience in a manufacturing environment with 3+ years of actual product development experience is required. Preference is given to FDA Class 2 orthopaedic medical devices development.
Excellent SolidWorks knowledge and skills for the creation and revision of parametric models and ASME Y14.5 compliant engineering drawings. Ability to interpret and perform tolerance stack-up analyses highly desired.
Advanced knowledge of MS Office computer required. Knowledge of MS Project preferred.
Proven history of leading design verification, design validation, test method validation, and/or process validation (IQ/OQ/PQ) testing required.
Knowledge of descriptive statistics and sampling methodology is required at minimum. Working knowledge of Minitab software desirable.
Well versed in ISO 14971 hazard analysis. Experience with creating dFMEA and pFMEA to inform hazard analysis desirable.
Working knowledge of ISO 11137 radiation sterilization standards, ISO 10993 biocompatibility standards, and FDA guidance on ISO 10993-1 highly desirable.
Technical Requirements
Excellent problem solving, strategic thinking, decision making, analytical, and oral / written communication skills required.
Results oriented, strong sense of ownership, and committed to achieving meaningful results.
Ability to work well under pressure to meet deadlines in a cross-functional team environment.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions.
Ability to work independently with minimal supervision on a daily basis.
Managerial Experience
Excellent problem solving, strategic thinking, decision making, analytical, and oral / written communication skills required.
Must be able to work within a lean, focused R&D group and manage/collaborate with cross-functional team members to achieve milestones.