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 Staff/Senior Staff Mechanical Engineer will work with a team of cross-functional development and manufacturing engineers on the continued development of identifeye’s devices from concept through production. In addition to contributing technically, this role will be responsible for leading a small but mighty mechanical engineering team, driving the team to successfully manage and meet deliverables. For a self-motivated engineer, this is a unique opportunity to jump into the middle of a fast-paced environment focused on high quality designs and delivery of devices that delight our customers.
As part of our team, your core responsibilities will be to:
- Work closely with internal and external stakeholders to develop fundamental specifications that will determine final system performance of a complex precision electro-opto-mechanical medical imaging system
- Design, bring-up, debug and validate designs for function and performance from concept through production
- Build system prototypes, develop and conduct experiments, perform V&V testing, gather data and analyses, validate performance of components, subassemblies, test setups and systems
- Play a key role in the DFM/DFA process as we transition to high volume manufacturing
- Specify, select, and qualify system components, develop and benchmark system performance, develop and implement test procedures, and evaluate and select appropriate test instrumentation
- Develop component, assembly, and system specifications and tolerances that satisfy clinical and functional input requirements and validate fabricated systems to ensure conformance to specifications
- Document and test new and existing parts, assemblies, and procedures to evaluate performance, patient safety, facilitate manufacturing, and satisfy applicable regulatory requirements
- Collaborate in the fabrication of mock-ups and prototypes for testing and evaluation, utilizing a variety of techniques including SLA, FDM, SLS, sheet metal and machining
- Manage development efforts with 3rd party vendors and contractors
- Own mechanical engineering team deliverables, with responsibility for project plans, budgets, timelines and resource allocation
- Coach, mentor and support engineers, cultivating a team-oriented environment with opportunities for learning and development
What We Are Looking For
Baseline Skills, Experiences, & Attributes:
- Bachelor’s Degree or Advanced Degree in Mechanical Engineering
- 10+ years of applicable experience in precision electro-mechanical systems design in an FDA or ISO regulated product development environment
- Prior experience in a supervisory, technical lead or project manager capacity. Proven ability to successfully manage competing priorities, ensuring timely fulfillment of project objectives and deliverables.
- Strong leadership acumen and passion for mentoring
- Working knowledge of applicable standards and regulations including ISO 13485, Quality System Regulation 21 CFR 820, ISO 9001, Risk Management and FMEA analysis
- Strong Cad/Cam skills with tools like SolidWorks (Fusion 360, OnShape, CREO or similar)
- Fluent with engineering drawings, tolerancing, and tolerance stack analyses of complex assemblies
- PDM and file management experience (Windchill, Solidworks PDM, GrabCad Workbench or similar)
- Solidworks Simulation Tools (Cosmos, Ansys, Comsol, Nastran or similar FEM tool)
- Additive 3D manufacturing expertise with Stratasys, Fomlabs, Markforge and the like
- Test, alignment and assembly tooling design and development experience
- Hands-on experience in prototyping and concept development. Extensive experience in engineering solutions to meet complex product requirements, verification and validation of subassemblies and production level systems.
- Working knowledge of mechanism and product design using injection molding, casting, machining and sheet metal parts that meet functional requirements and are suited for mass production
- PLM systems (Omnify preferred). ECO processing of engineering documentation, work instructions, procedures, and specifications.
- Title subject to change and dependent on experience
- 5+ years of engineering development experience in a small fast-paced start-up environment
- Prior experience managing a Mechanical Engineering team
- Design, analysis and fabrication experience with optomechanical systems
- Very experienced with DFM, DFA techniques and initiatives
What We Offer
- Fully covered medical insurance plan, and dental & vision coverage. As a health-tech company, we place great worth on our team’s well-being.
- 401(k) plan. Everyone should be encouraged to save for their retirement adventures!
- Flexible PTO policy and remote/hybrid work arrangements. We believe in taking personal responsibility for managing our own time, workload and results.
- Free onsite meals & kitchen stocked with snacks at our office locations.
- Annual "Improve Your Work Environment" stipend. We support what you need to be your best self when at work!
- Professional development reimbursement. Let's grow together!
- More exciting employee perks... but most importantly, the opportunity to build a revolutionary healthcare product and save millions of lives!
For this role, we provide visa assistance for qualified candidates.
identifeye HEALTH Inc. does not accept agency resumes.
identifeye HEALTH Inc. is an E-Verify and equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.