Senior Product Manufacturing Engineer - Guilford, United States - identifeye HEALTH

Description

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 communication skills
• Strong presentation and negotiation skills, with ability to influence internal and external customers on technical issues
• Strong organizational skills
• Experience with Google Workplace and Microsoft Suite

Preferred Qualifications:

• Advanced Degree in a related discipline
• Green Belt Certification or higher in Lean Manufacturing and/or DMAIC Six Sigma
• Knowledge of gears, motors, sensors, and complex electromechanical assemblies
• Familiarity with manufacturing automation tooling (e.g. functional testers, assembly tooling, in-circuit testers)
• Knowledge of printed circuit board assembly processing

Physical Job Requirements:

The physical demands described within the responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to be independently mobile
• Must be able and willing to lift 40 lbs
• This position is required to work onsite at our office location in Guilford, CT
• This position may require travel between 15-25% of the time

What We Offer

Anticipated Salary Range: $115,000 to $145,000 annually. The base salary range represents the anticipated low and high end of the salary range for this position. Actual salaries will vary and may be above or below the range based on various factors including but not limited to work location, operational needs, potential employee qualifications and other considerations permitted by law. The range listed is just one component of our total compensation package for employees. Other rewards may include annual bonuses, equity and program-specific awards.

In addition, we provide a variety of other benefits to employees including but not limited to:

• 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

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.