Senior Product Manufacturing Engineer

Who We Are

Join us on our mission to democratize access to the abundance of health information in the human eye! Here at identifeye HEALTH Inc., we’re pioneering a new branch in diagnostics between laboratory medicine and radiology, that will enable regular non-invasive health monitoring for both ocular and systemic diseases. 

We believe in empowering the individual by building approachable and intuitive products to provide personalized health insights to each and every patient. Our products are portable, affordable, easy to use and connected devices for early disease detection and monitoring.

We are born from 4Catalyzer - a rapidly growing health-tech incubator founded by Dr. Jonathan Rothberg, an award-winning scientist and highly successful serial entrepreneur. We are fostering a culture of technical excellence where you have the opportunity to learn, explore and see your ideas come to life. 

Joining identifeye HEALTH is the opportunity to redesign the future of healthcare through the power of technology. We are here to solve real-world problems and maximize global impact, motivated by the idea that our products will change lives, including the ones of people you love.

What We Live By

• Prioritize the Patient - We make products that remove barriers between quality care and the people who need it 
• Data-Driven Decisions - We search for the best solutions; objective, backed by data, and optimized for speed, simplicity and scale
• Support Each Other - We celebrate the ideas and contributions of our teammates and recognize that we can only succeed as a team, and when each person feels heard and valued
• Simplify - We build intuitive solutions to simplify patient care

What You Will Be Doing

The Senior Product Manufacturing Engineer will be a key member of the identifeye HEALTH Manufacturing team. As the Senior Product Manufacturing Engineer, you will be the operations subject matter expert, driving close alignment with cross functional teams to meet manufacturing and R&D deliverables. This position will have multiple technical responsibilities supporting R&D internally, as well as with our contract manufacturing partners (CM) in the following areas of focus: manufacturing engineering, manufacturing test, industrial engineering, product packaging, graphics and labeling, assembly tooling, supplier tooling, and other initiatives associated with the development and commercialization of our product.  

As part of our team, your core responsibilities will be to: 

• A technical lead collaborating closely with program management both internally and externally supporting the execution of key programmatic deliverables
• Lead process development support with our CM partners and associated suppliers on establishing the appropriate capital assembly tooling strategies
• Support the coordination and review with our CM partners on cost of goods estimations, capacity planning models, manufacturing builds, and process validation efforts
• Support cost down initiatives with the CM by actively working with the CM partners and their suppliers to improve efficiencies and aid in problem resolution within the manufacturing work stream
• Collaborate with R&D on design change management impacts to manufacturing
• Cross functional team member supporting CM and tier 2 supplier on DFM, DFA, and DFT efforts
• A technical contributor on DFMEA, and technical lead on PFMEA and control plan efforts
• Technical oversight with the CM ensuring that bills of materials, assembly drawings, and assembly process instructions are clearly defined
• A cross functional lead in collaboration with all R&D, QA/RA, and the CM on labeling, graphics and general operational initiatives 
• Advise management on programmatic developments which impact schedule and costs

What We Are Looking For

Baseline Skills, Experiences, & Attributes: 

• Bachelor’s Degree in Mechanical, Electrical, Manufacturing or a related engineering discipline
• 5+ years of applicable engineering experience, with at least 3 years within medical devices
• Familiarity with quality and regulatory requirements including FDA’s Quality System Regulation, ISO 13485, etc. 
• 3+ years of experience in process validation (IQ/OQ/PQ) and working knowledge of DFMEA and PFMEA
• Knowledge of Design for Excellence principles (e.g. DFM, DFA, DFT, DFS) 
• Prior experience with contract manufacturers and suppliers, including ECOs and SCARs 
• Strong written and verbal communica