Product Development Engineer

A:  Purpose and Scope

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 cleared by the FDA. 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.

A willingness to work in Fremont is required.

B:  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.

C:  Organizational Relationships

This position reports to the Director of Research and Development

JOB REQUIREMENTS

A:  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.

B:  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.

C:  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.