A BIT ABOUT SIBEL HEALTH:

With headquarters based in Chicago, Illinois and an international office in Seoul, South Korea, Sibel Health is an award-winning digital health startup with a mission to deliver Better Health Data for All®. We were founded with a specific focus on our most vulnerable patients—pregnant persons and babies—where we believe wireless monitoring has the potential to do the most good worldwide. We achieve this by providing a complete monitoring solution of advanced wireless wearables, best in class software, and novel AI/ML algorithms all linked to the cloud. To date, we’ve launched our technologies in 20 countries from the most advanced hospitals in the world to the most resource constrained locations. We work with some of the most respected healthcare organizations in the world from major philanthropies to large medical technology and pharmaceutical companies. With numerous FDA clearances and a recently completed fundraising round, we are poised for growth and expansion. We are seeking mission-driven individuals with a strong sense of purpose who believe that technology can improve the lives of our most vulnerable patients.

THE OPPORTUNITY:

We are looking for a Senior Mechanical Engineer to join our team. In this role, you will be responsible for the development of mechanical architecture for new products and provide technical leadership for existing products as needed. Reporting to the Mechanical Engineering Manager, you will function as a technical resource in the design and development of wearable sensors and provide quality support for medical product development and change control. Sibel’s fast-paced environment offers ample opportunities for growth in several areas: improved technology skills, effective leadership, dedicated mentorship, creative design, strong communication skills, teamwork, and more. 

WHAT YOU WILL BE WORKING ON:

• Develop procedures and deliverables, ensuring their compliance with medical quality system requirements and applicable regulations and standards (such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards). 
• Conduct complex investigations pertaining to the development of new designs, methods, materials or processes, and investigate possible applications of the results.
• Drive mechanical design and development efforts through Stage 2 and 3 PDP.
• Lead ME Requirements definition for NPI.
• Work closely with V&V Leads in Test Planning and Execution.
• Act as Lead interlocutor for the ME Team for internal manufacturing, internal design teams and external manufacturers, test facilities and engineering service providers.
• Assiduously optimize product costs while executing with unerring fidelity to project scheduling requirements.
• Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, overall design controls, design verification, design validation, investigations, CAPA data, etc. to assure product quality.
• Assure conformance with regulations of the FDA and other international regulatory agencies and may assist in providing responses to the FDA and other regulatory agencies with respect to medical device compliance.
• Active participant in developing and maintaining product risk management files in line with ISO 14971.
• Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.
• Provide support, guidance and direction for bringing on-market product issues to closure and escalating to senior management for support as necessary.
• Prepare, support and ensure the readiness for any potential internal and/or external audits and inspections.
• Keeps abreast of the latest technology developments to ensure the company sees available opportunities for technical improvements in products and services, and/or cost reductions.
• Interact with Clinical and Marketing departments to determine design requirements and goals.
• Select vendors for prototypes, request quotes and prepare purchase requisitions.  Provide recommendations for production vendors.
• Help develop assembly procedures and assist in transfer methods to manufacturing.
• Document ECO changes within the Document Control system.

Products under development are likely to include:

• Injection molded plastic parts, mechanical layout of flex circuits, elastomeric components, machined components, films, electrical connectors and cables, use of force, and temperature sensors, design of seals for fluid ingress protection.

ABOUT YOU:

• Bachelor’s degree in Mechanical Engineering or Biomedical Engineering.
• BSME with 7+ years’ experience in mechanical design and product development or MSME with 5+ years’ experience with research or focus in technical areas relevant to biomedical science and/or technology.
• Demonstrated technical leader with an ability to manage multiple priorities, focus efforts, overcome obstacles, and complete key objectives.
• Ability to independently research, propose and implement new technologies that impact current NPI initiatives, as well as introduce new biomedical applications of soft sensors.
• Understands and efficiently implements DFx in product development.
• Ability to create cost-effective mechanical architecture given user needs and design inputs.
• Creative engineer and problem solver with technical experience in the development of biotech products through the PDP process.
• Ability to work closely and collaboratively with other members of the multi-disciplinary development team in a fast-paced team environment.
• Demonstrated understanding of how the product/project meets the needs of the customer and organization.
• Comprehensive understanding of PDP, V&V and the ability to drive Requirements Definition.
• Excellent CAD skills, design of plastic injection and compression molded parts, sheet metal components, development and execution of tests for evaluation and verification.
• Broad knowledge of plastic and metal materials with the ability to define the selection criteria and tradeoffs for different materials.
• Ability to conduct thermal and mechanical analysis as well as statistical analysis.

YOU MAY THRIVE IN THIS ROLE IF YOU HAVE…

• At least three years of experience in medical device product development, ideally Class II or Class III devices.
• Demonstrated abilities and willingness to wear “multiple hats” and perform a wide range of tasks within a dynamic environment - must demonstrate energetic initiative!
• In-depth experience with and broad knowledge of rapid prototyping (3D printing) methods and hands-on skills using common machining and modeling tools and materials.
• Experience with SolidWorks modeling of plastic and elastomer molding design machined, compression molded and injection molded parts is desired.
• Ability to interpret industrial design concepts and translate into manufacturable product designs.
• Resourcefulness in OTS materials, parts and systems identification and acquisition.
• Knowledge of ASME dimensioning and tolerance standards GD&T.
• Ability to read, analyze, and interpret engineering specifications, technical procedures, or governmental regulations. 
• Ability to effectively present information and respond to questions from groups of managers, clients, and customers. Ability to convey project accomplishments, obstacles, issues, and project status clearly and concisely. 
• Knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.)
• Experience with and knowledge of FDA, EU MDR, and other key medical device regulations. 
• Well-developed ability to take a systems approach and to understand the interaction between components (i.e. hardware, software, consumables as applicable).

BENEFITS:

• Medical, dental, vision, life, and disability insurance.
• "Take as much time as you need" policy.
• Simple IRA plan with employer matching.
• Company sponsored events and lunches.
• Stipend for professional development.
• Opportunity to be part of a dedicated and driven team that is here to disrupt and revolutionize wireless monitoring.

Sibel Health Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.