Senior Product Development Engineer

POSITION SUMMARY:

The Sr. Product Development Engineer designs and develops Class I & II medical devices for eye surgeries, such as vitrectomy probes. These devices have features down to 2 micrometers that need to be precisely manufactured and assembled. As a team member of the R&D Department, close collaboration with the Manufacturing Engineering, Quality and Production Teams is part of the daily routine. Responsibilities include improvement projects as well as end-to-end product developments from concept to manufacturing. Critical thinking is essential at all stages of the development process.

RESPONSIBILITIES:

• Performs complex mechanical designs, engineering analyses and feasibility studies for new components or products
• Works out the design requirements and determines optimum design choices, including via trade-off studies of various options.
• Approaches troubleshooting by methodical, scientific means to identify root cause prior to implementing possible solutions through redesign
• Thorough documentation of work performed, as required by the regulatory environment per 21 CFR 820.
• Researches, understands, and presents information relating to Regulatory and Environmental Standard compliance requirements as it relates to product and processes.
• Collaborate with Manufacturing in supplier selection, manufacturability, and the transition from R&D to manufacturing to ensure smooth and efficient design transfer.
• Supports evaluation for viable Engineering Changes
• Research new enabling technologies and manufacturing techniques and determine feasibility.
• Responsible for project related functions including preparing, managing, and facilitating development of plans, schedules, tasks and resources from conception to volume manufacturing
• Generate technical drawings of systems, components, and interfaces based on inputs provided by others.
• Provides sustaining engineering support for existing products.
• Work in a stage-gate product development process following principles of FDA design controls
• Engage with cross-functional teams including Quality Assurance to ensure smooth project execution.
• Generates patentable designs and proprietary manufacturing processes.
• Competitive market analysis

REQUIRED SKILLS AND EXPERIENCE:

• Proficient in SolidWorks, FEA, GD&T
• Demonstrated ability to solve problems via scientific methodology and analysis (for example Theory of Knowledge)
• Medical Device experience, FDA 21 CFR 820 & ISO 13485
• Familiar with the manufacturing, assembly and bonding processes of consumable medical devices.
• Experience with sterilization, biocompatibility requirements
• Developing IQ/OQ/PQ, process validation documents
• Risk Management per ISO 14971.
• Requirements definition and traceability through verification and validation testing
• Works and communicates effectively with people from all levels of the organization
• Flexible and willing to perform other tasks as assigned
• Travel – less than 10%, domestic & international

EDUCATION:

BS in Mechanical Engineering, Physics, or equivalent, 8 years of experience

Advanced degree desirable

ADDITIONAL SKILLS AND EXPERIENCE DESIRED:

Methodical root cause analysis (DMAIC), detail-oriented

Mechanics of materials

Electronics concepts to control valves and pumps for liquid management systems

Micro-machining techniques

Familiar working with suppliers and vendors

Use of standard machine tools to fabricate simple tools and fixtures is a plus

Annual Compensation: $150,000 – $180,000 DOE (Depending on Experience)

Location: San Leandro, CA (Onsite, Full-time)

Company Website: www.midlabs.com

Employment Type: Full-time

Medical Instrument Development Laboratories, Inc. (MIDLabs) is an equal opportunity employer. We are committed to fostering an inclusive, diverse, and respectful work environment and do not discriminate based on race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, or any other legally protected characteristic. Applicants from all backgrounds are encouraged to apply.